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- 2025-12-17 07:27:31
- InterView
- "ADC use sufficient in neoadjuvant therapy of breast cancer"
- by Son, Hyung Min Dec 16, 2025 08:35am
- The potential of utilizing the Antibody-Drug Conjugate (ADC) Enhertu is being confirmed in the neoadjuvant setting.At the European Society for Medical Oncology Asia (ESMO Asia 2025) annual meeting in Singapore, clinical outcomes for Enhertu (trastuzumab deruxtecan) in patients with advanced HER2-positive breast cancer were recently disclosed.In an interview at the conference, Professor Chang Ik Yoon of the Division of Breast Surgery at Seoul St. Mary's Hospital evaluated Enhertu as an option with sufficient clinical value not only for metastatic breast cancer but also for advanced HER2-positive breast cancer requiring neoadjuvant treatment, demonstrating the potential to overcome the limitations of the existing standard of care.In the treatment of advanced breast cancer, pathological complete response (pCR) is a key indicator for lowering the risk of recurrence and improving long-term survival. However, a limitation of the existing standard of care TCHP, combining Herceptin (trastuzumab)·Perjeta (pertuzumab)·cytotoxic chemotherapy, is that approximately half of the patients fail to achieve pCR in real-world clinical practice.Professor Chang Ik Yoon of the Division of Breast Surgery at Seoul St. Mary's Hospital The Phase 3 DESTINY-Breast11 study, designed to address this unmet need, evaluated Enhertu's potential as a neoadjuvant therapy in 927 patients with advanced HER2-positive breast cancer. The result showed that the pCR rate in the Enhertu combination group was 67.3%, which was 11.2 percentage points higher than that of the existing standard treatment, the ddAC-THP group (56.3%). This double-digit gap in the early·advanced breast cancer setting is considered a clinically meaningful difference.Consistent improvement was also confirmed in subgroup analyses. In the Hormone Receptor (HR)- positive patient group, the pCR rate with the Enhertu combination therapy was 61.4%, 9.1 percentage points higher than in the control group (52.3%). Notably, the gap widened further in the HR-negative patient group, highlighting the therapeutic value of this approach in this high-risk population.Professor Yoon stated, "Even with earlier use of the treatment, there were no distinct disadvantages in terms of side effects. The safety profile showed a more stable pattern." Professor Yoon projected that "the scope of Enhertu's utilization in pre-operative treatment strategies will continue to expand."Q. We would like to ask about the background of today's session. Regarding the neoadjuvant data presented at ESMO, some medical oncologists expressed the view that the clinical significance was not substantial. Would you share your views?The answer to this question depends on one's perspective. There have already been several prior studies. The common and crucial endpoint examined in these studies was pCR.HER2-positive breast cancer accounts for approximately 20–25% of all breast cancers. The pCR rates following conventional chemotherapy range from about 50% for HR-positive, HER2-positive cases to up to 80% for HR-negative/HER2-positive cases. Combining these, approximately 65% achieve pCR, meaning roughly one-third, or 35%, do not.The pCR rate reported in the latest DESTINY-Breast11 study was around 67%. Placing this figure alone next to the existing data, the difference is not dramatically significant. However, the results were better than those of the control group, which received anthracycline (AC) chemotherapy followed by THP.However, some points don't align well with the South Korean setting. Doxorubicin (adriamycin) in the AC therapy is an agent with cardiac toxicity, and HER2-targeted therapies also carry a cardiac toxicity risk. Because using both together increases the risk of cardiac side effects, there is a clinical tendency in South Korea to avoid AC whenever possible. In contrast, it is still frequently used overseas. In that sense, the fact that Enhertu showed similar or even better results without using AC is a clear advantage.Q. Why is AC still used overseas despite its cardiac toxicity?AC is one of the major chemotherapy agents that has traditionally improved survival and recurrence rates in breast cancer treatment. It is a drug that, along with the taxane-type agents, has proven survival benefits. However, its use has somewhat declined since the introduction of HER2-targeted therapies due to concerns about cardiac toxicity.Despite this issue, there is still the understanding that significant problems do not arise when the cumulative dose is not high. Because the cardiac toxicity of HER2-targeted therapies is relatively manageable, they are still combined with AC in many overseas settings.Q. Why has the TCHP regimen been used more often in South Korea?The underlying perception in Korea was that there was no need to deliberately expose patients to the risk of cardiac toxicity if the difference in pCR rates was not significant. Therefore, the regimen most widely used has been the TCHP regimen administered over six cycles.Following the introduction of Enhertu, number of chemotherapy cycles can be reduced from six to four, and that earlier treatment does not incur a significant safety penalty; in fact, the safety profile appeared more favorable.Q. How clinically significant do you consider regarding pCR being approximately 10% difference in?In most studies, pCR is accepted as an indicator correlated with reduced recurrence rates and increased survival. Since actual survival data takes time to mature, pCR is utilized as an essential surrogate marker to predict long-term outcomes. Especially in HER2-positive and triple-negative breast cancer, pCR is almost synonymous with reduced recurrence risk and improved survival.However, the question of how meaningful a 10% increase is when pCR rates are already approaching 70-80% is fair. It is also possible to interpret that even if the pCR rate is slightly lower, the difference in long-term survival may not be significant because additional treatment is given during the subsequent adjuvant therapy.Q. Oncologists may have concerns about using such a powerful option too early in the neoadjuvant stage.Yes. Patients who do not achieve pCR are considered high-risk for recurrence, and choosing subsequent adjuvant therapy is critical. If a superior option has already been used in the neoadjuvant stage, the question of what to use next is unavoidable.While prospective data on subsequent treatment are currently insufficient, this does not mean that options are entirely nonexistent. As subsequent studies emerge, this aspect will be gradually resolved.Q. Do you believe the current results alone are sufficient to support the use of Enhertu in the neoadjuvant setting?In my opinion, it is sufficient for patients who achieve pCR. In these cases, the 5-year recurrence risk is less than 10%, indicating that the current standard treatment is adequate. The issue lies with patients who have residual disease.The KATHERINE study shows that HER2-positive breast cancer patients with residual disease after neoadjuvant therapy had an 8-year recurrence risk of about 20% even with the existing standard treatment. However, the DESTINY-Breast05 results suggest the possibility of reducing this recurrence risk to approximately 8% at 3 years. The hazard ratio indicates that the risk is nearly half.In other words, the reason not to be overly relying on pCR is that subsequent treatment options have improved, allowing for further intervention to lower the risk of recurrence.Q. Can Enhertu be used in the neoadjuvant setting and then used again later?It is possible. We already know that Enhertu is a better drug than Kadcyla, and a strategy of using it again, if necessary, can be considered. However, cost and reimbursement issues will be separate concerns.The core strategy is personalized treatment: de-escalating therapy for patients who achieve pCR and intensifying treatment for those with residual disease.For instance, with the old standard of care, a patient who achieved pCR would still need 14 cycles of Enhertu afterward. If pCR is achieved with only 4 cycles of Enhertu during neoadjuvant therapy, that patient would not require the additional 10 cycles. A patient group clearly benefits from this.Q. There was also criticism of the study design regarding why it only looked at the neoadjuvant stage and not the perioperative (pre- and post-operative) setting.The recent trend in research questions whether all patients need to complete the full course of chemotherapy. The approach is to see if treatment can be reduced for patients who show a good response.For example, studies like PHERGain adjust treatment based on an interim response evaluation. In this context, the design to identify early responders by using Enhertu upfront is a meaningful attempt. However, the failure to clearly define the subsequent strategy for patients with residual disease can be confusing, and may need further research.
- InterView
- ‘Imfinzi demonstrates rationale for perioperative immunotherapy in gastric cancer’
- by Son, Hyung Min Dec 15, 2025 11:02am
- The role of adjuvant systemic therapy is emerging as an important consideration even in patients with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.Despite outstanding surgical outcomes in East Asia, a significant proportion of patients with stage II-III locally advanced disease still experience recurrence due to micrometastases. In this context, a perioperative treatment strategy, which involves systemic therapy before and after surgery, has emerged as a promising approach to enhance long-term outcomes.At the recent ESMO Asia Congress 2025 held in Singapore, results from an Asian subgroup analysis of the Phase III MATTERHORN study were presented, reinforcing the clinical value of Imfinzi (durvalumab) in combination with standard FLOT chemotherapy (5-FU, leucovorin, oxaliplatin, and docetaxel).In the study, Imfinzi plus FLOT demonstrated clinically meaningful improvements in event-free survival (EFS), 3-year overall survival (OS), and pathological complete response (pCR). These findings signal a clear shift toward earlier use of immunotherapy in resectable gastric cancer.Surgery remains the cornerstone of the cure in gastric cancer. However, there is growing global consensus, including in Asia, that surgery alone is insufficient for many patients. The MATTERHORN study demonstrated that administering a combination of chemotherapy and immunotherapy prior to surgery, followed by curative resection and additional therapy afterward, can significantly improve long-term outcomes.Based on these results, the U.S. Food and Drug Administration (FDA) approved Imfinzi for the treatment of adult patients with resectable, early-stage, and locally advanced (stages II, III, and IVA) gastric and gastroesophageal junction (GEJ) cancers last month. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.At ESMO Asia 2025, Daily Pharm spoke with Dr. Yelena Y. Janjigian, first author of the MATTERHORN study (Chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center), as well as Professor Sun Young Rha of Yonsei Cancer Center (President of the Korean Cancer Association) to discuss the clinical implications of this shift and the challenges associated with its implementation in Korea.Q. As the first author of MATTERHORN, what prompted the development of this perioperative immunotherapy strategy for patients with resectable gastric and GEJ adenocarcinoma, and what is the clinical significance of the results?Professor Yelena JanjigianDr. Yelena Janjigian: MATTERHORN holds significance as the first Phase III study in the resectable, early-stage setting to demonstrate improvements across pCR, EFS, and OS with chemo-immunotherapy.At ESMO Asia, we presented subgroup results from Japan, Korea, and Taiwan, which were consistent with the global findings. These data support the global relevance of the perioperative approach.With recent FDA approval for resectable gastric and GEJ adenocarcinoma, aligning treatment approaches across regions will help us move the field forward, especially given the global incidence of more than 1.2 million new cases each year.Q. The Asian subgroup showed efficacy and safety trends consistent with global results.Professor Yelena Janjigian: Three key points are important. First is the feasibility across regions. Perioperative Imfinzi was deliverable in Asian centers, and physicians were able to administer both FLOT and durvalumab safely.It also did not compromise surgical care. Rates of complete (R0) resection and the ability to proceed to surgery were maintained.Furthermore, the results showed improvement across all major efficacy endpoints—pCR, EFS, and OS. The ability to improve all three endpoints in one study is unprecedented in this setting and underscores the strength and value of the data.Q. What considerations should clinicians keep in mind when applying the regimen in earlier-stage patients?Professor Yelena Janjigian: The study enrolled a broad age range—from 18 to 84 years—and older patients benefited similarly to younger patients.That said, some patients, particularly in Asian populations, may present with nutritional compromise or lower baseline white blood cell counts. Asian investigators are familiar with these characteristics. Strategies such as early G-CSF administration and careful initial dose tailoring of FLOT can help maintain safety while preserving efficacy.Most importantly, close clinical monitoring, hydration, and supportive care are essential components of successful perioperative treatment.Q. Some Korean clinicians believe the regimen may be more suitable for stage III or IV than stage II. What is your view on this?Professor Yelena Janjigian: Clinical staging in gastric cancer is often imprecise. A patient staged clinically as T2 may be found at surgery to have T3N1 disease. Because many patients have difficulty tolerating intensive postoperative therapy after major gastrectomy, preoperative treatment becomes particularly valuable.We believe the greatest benefit of chemo-immunotherapy occurs when the tumor remains in place, allowing optimal priming and expansion of anti-tumor T-cells. This is supported by the stronger efficacy observed in the neoadjuvant component compared with adjuvant-only settings.In my clinical practice, even patients with clinically estimated T2 tumors—especially those with diffuse or signet-ring histology—are discussed in a multidisciplinary context for consideration of perioperative systemic therapy.Additionally, the shift in tumor epidemiology in Asia—with increasing proximal and GEJ tumors—further supports the need for downstaging approaches, as these tumors historically have poorer surgical outcomes.Q. How should we interpret the potential for non-operative management in early gastric cancer?Professor Yelena Janjigian: This area is highly exploratory and remains limited to very select patients within clinical trials or specialized centers.In certain patients who achieve a complete clinical and pathologic response and who can reliably adhere to intensive surveillance, non-operative strategies have been examined. However, this is not standard practice and remains controversial, particularly among surgeons.Nevertheless, these discussions reflect a broader evolution toward balancing cure with long-term quality of life. Gastrectomy, even when minimally invasive, alters eating patterns, sleep patterns, and body image. For selected patients, preserving the stomach—when supported by rigorous evidence and strict monitoring—could represent a meaningful advance, but this requires further research before it can be broadly implemented.Q. Gastric cancer has historically been viewed as a disease with favorable surgical outcomes, leading to a lesser emphasis on chemotherapy. Yet MATTERHORN highlights the importance of perioperative treatment. Why is this approach necessary?라선영 연세암병원 교수Professor Sun Young Rha: MATTERHORN enrolled patients with stage II and III gastric cancer eligible for curative surgery. While stage I “early gastric cancer” is often cured through endoscopic treatment or gastrectomy, stage II–III cancers are locally advanced and carry significantly higher recurrence risk.In East Asia, surgery followed by adjuvant chemotherapy has historically yielded strong outcomes, with five-year survival rates around 75–80%. Still, approximately 30–40% of stage III patients experience disease relapse, demonstrating a significant unmet need.Perioperative therapy aims to eradicate micrometastases after surgery and sustain systemic control afterward. In Western countries, perioperative FLOT has become the standard to achieve a better tumor resection, considering factors such as the increased obese population and different tumor extent at GEJ.Q. What are the key findings of MATTERHORN, and which patients are most likely to benefit from D-FLOT?Professor Sun Young Rha: The MATTERHORN study is significant in that it introduces a new treatment option for patients with locally advanced, resectable gastric cancer. Notably, a distinct survival benefit was observed in high-risk stage III patients with a high tumor burden. It is also noteworthy that the overall survival curve suggests the possibility that more than half of patients may remain alive at five years.However, it should be noted that MATTERHORN did not compare the experimental arm with the post-operative adjuvant chemotherapy that has been long used in Korea or Japan, but rather with FLOT, which is considered the global standard of care. While FLOT is highly effective, Asian patients may encounter challenges in completing treatment due to its relatively high intensity.Therefore, especially in Asia where surgical outcomes are generally more favorable, it may be more appropriate to selectively apply this regimen to patients with high-stage disease.Q. If the D-FLOT regimen becomes available in Korea, which patients would be the most appropriate candidates?Professor Sun Young Rha: If ongoing follow-up continues to support the favorable outcomes observed in stage III patients—particularly in terms of EFS and 3-year OS—this group will likely be prioritized in Korea.For stage II patients, surgery followed by adjuvant chemotherapy already yields a 5-year OS rate up to 80%, and the potential incremental benefit of perioperative D-FLOT must be balanced against its higher treatment burden and toxicity profile.In MATTERHORN, approximately 40–50% of patients completed the full perioperative regimen, reflecting the challenges associated with the adjuvant FLOT component. This underscores the importance of careful patient selection. Stage III patients, who have higher rates of micrometastatic disease and a 30–40% recurrence risk within two years, are expected to derive the greatest benefit.Clinical features such as extensive nodal involvement, T4 tumors, or biologically aggressive histology should guide decision-making. Biomarker-informed approaches will increasingly help tailor treatment intensity and minimize unnecessary toxicity.Q4. What distinguishes Asian patients from Western patients in MATTERHORN?Professor Sun Young Rha: A notable feature of Asian patients enrolled in the MATTERHORN study is that they generally had good performance status and a relatively lower tumor burden. In countries such as Korea and Japan, where early detection rates are high and surgical outcomes are excellent, patients enrolled in clinical trials can potentially have better overall performance status compared to their Western counterparts.While the proportion of stage IV patients in the study appears somewhat high, it should be interpreted as including patients with high-risk, advanced gastric cancer characterized by deep tumor invasion or extensive lymph node involvement, rather than those with unresectable or incurable M1 metastatic disease.In the MATTERHORN study, Asian patients represented approximately 20% of the total population, indicating that additional real-world experience will be needed to further strengthen the evidence base. It will be important to continue accumulating data from Asian patients to more clearly define the clinical significance in future practice.Q. What challenges must Korea overcome to adopt perioperative durvalumab?Professor Sun Young Rha: Above all, aligning treatment approaches between surgeons and medical oncologists is essential. Especially in Korea and Japan, where surgical outcomes are outstanding, and the paradigm remains surgery-centric. Consensus-driven discussions with surgeons are needed to establish the role of perioperative immunotherapy in high-risk advanced gastric cancer. To ensure patients do not lose access to optimal treatment options, multidisciplinary collaboration is vital for designing comprehensive treatment plans.From a medical oncology standpoint, individualized dose adjustment and proactive management of adverse events are key, particularly given the complexity and toxicity of the FLOT regimen. Active supportive care (such as antiemetics, G-CSF support, and dose modification) is necessary to help Asian patients complete therapy.Finally, reimbursement is a major hurdle. Without sustainable reimbursement pathways, early real-world adoption will be limited. Generating clinical experience and real-world data, especially in high-risk stage III patients who are most likely to benefit, is important to help establish the evidence base needed for broader access.
- InterView
- [Reporter's View] Generic price cuts…SME status
- by Choi Da Eun Dec 11, 2025 08:39am
- The price reduction of generic drugs in South Korea is once again putting severe pressure on small and medium-sized pharmaceutical companies. If the proposed price cuts are implemented, small and medium-sized pharmaceutical companies that heavily rely on generic sales will face greatest impact. For these companies, where over 70% of revenue comes from generics, a reduction of over 10% in drug prices could threaten their foundation.Drug pricing policy has been continually strengthened to ensue the sustainability of the National Health Insurance fund. Significant price reductions began in 1999 when the government reformed the drug reimbursement system, lowering prices for listed pharmaceuticals by an average of 30.7%. This was followed by the 'Drug Expenditure Rationalization Plan (DERP)' in 2006, which reduced the price of generics from 80% to 68% of the original product price.As high-cost drug usage and the launch of generics expanded in the late 2000s, concerns over the health insurance fund's financial deterioration intensified. The government undertook a major reform of the drug pricing system in 2012. This action eliminated the 'step-wise drug pricing system,' which gradually lowered prices based on the generic's market entry rank, and implemented a 'Comprehensive Price Reduction,' unifying the ceiling price for both off-patent original drugs and generics to 53.55% of the original price.Recently, the reform announced by the Ministry of Health and Welfare includes a plan to secure funding to improve access to innovative new drugs by further reducing generic prices. It is intended to lower the existing generic price standard from 53.55% to the 40% range. The government aims to implement this change in the latter half of next year.The limitation of the generic industry has long been predicted. The companies that are hit first and hardest by these price cuts are the domestic small and medium companies that lack robust R&D or global business foundations. Many firms introduced identical-component, identical-formulation products, fragmenting the market. Now, increased manufacturing costs in addition to further price cuts have severely dropped profitability.Excluding companies with high reliance on Contract Development and Manufacturing Organization (CDMO) or non-reimbursed products, the average operating profit margin for 100 domestic pharmaceutical companies over the last three years was a merely 4.8%, with a net profit margin of only 3%.The problem in these drug pricing reforms is simply focusing on reducing government health insurance expenditure. Conversely, the strategic support framework for the industry following these price cuts remains vague and ambiguous. While the government supports the pharmaceutical and bio industry as a future driver, it appears indifferent to the harsh realities facing the companies that are behind it. Current pricing regulations effectively become a price pressure mechanism that forces smaller companies out of the market first.The most significant expected adverse effects of the price reductions are cuts in R&D spending and corporate restructuring. Companies facing immediate operational cost depletion and severe financial distress will likely view R&D as a luxury, inevitably leading to a reduction in demand for specialized personnel. The market reality and policy objectives are clearly flawed and clash.Of course, pharmaceutical companies must also adjust their portfolios and profit strategies to cope with government regulatory pressure. For instance, they must maintain generic-based revenue while aggressively cutting down lower-profit items. If R&D burden is high, a cost-diversified research approach is necessary, such as through collaboration utilizing AI, platform technologies, and external R&D partnerships.It is difficult to deny that price reduction is a tool for stabilizing the health insurance fund and that more resources should be allocated to innovative new drugs. However, the approach of solving the problem solely through price cuts is overly simplistic. If financial efficiency directly undermines industry competitiveness, it will only worsen profit polarization among pharmaceutical companies, leaving the government's vision for the pharmaceutical industry a mere illusion.
- InterView
- [Reporter’s View] Patients must feel the benefits
- by Son, Hyung Min Dec 08, 2025 08:58am
- South Korea has long been one of the world's most challenging markets for new drug entry. Global pharmaceutical companies, and even domestic firms, have historically been slow to step into Korea. The excessive delay in the time from approval to reimbursement compared to major countries was also a significant problem. Naturally, the term “Korea Passing” became an almost permanent fixture in the industry’s vocabulary.However, starting next year, this long-standing structure will begin to change. The Ministry of Health and Welfare has decided to overhaul the drug pricing system, which had remained as is for years, introducing measures like dual pricing, indication-specific pricing, and non-disclosure agreements.The backdrop to the government opening the door to drug price reform after over a decade of inaction lies the change triggered by the United States. When the Trump administration announced a policy to lower U.S. drug prices to most-favored-nation levels, global pharmaceutical companies' procurement strategies were shaken. Korea’s unusually low price levels emerged as a risk factor in global pricing strategies.Recent direct meetings between U.S. pharmaceutical association officials and the Korean government, where they conveyed concerns that “if this continues, Korean patients will be unable to use innovative new drugs,” are an extension of this trend.Korea’s low prices and long reimbursement timelines have already led to delayed launches or withdrawal of several therapies.Patient access to new medicines in Korea remains severely limited. According to the Korea Research-Based Pharma Industry Association (KRPIA), only 5% of global new drugs enter Korea within a year of their first global launch—just one-quarter of the OECD average. Korea’s new-drug approval rate (30%) is also far below the OECD average (49%) and the G20 average (46%).Some companies have completely withdrawn from the Korean market due to low drug pricing after patent expiration. AstraZeneca's decision to withdraw domestic sales of ‘Forxiga (dapagliflozin)’ after its patent expired is a notable example.The government’s new reform package seeks to directly address these challenges. From Dual pricing—separating list prices from actual transaction prices—to indication-based pricing, higher generic prices for R&D-intensive companies, these moves are closer to flexible drug pricing policies aligned with international standards.In other words, Korea is belatedly adopting approaches already established in the US and Europe. The direction of significantly lowering generic drug prices while protecting exit-prevention drugs and essential medicines, and providing incentives to innovative pharmaceutical companies, is seen as a flare signaling the restructuring of the pharmaceutical industry.The government has reset the playing field for the first time in a decade, and it’s the companies' turn to respond. We cannot allow a repeat of the situation where global anticancer drugs, approved for dozens of indications, fail to enter the Korean market due to pricing burdens, leaving some indications unaddressed or neglected. Nor can the strategy of deprioritizing Korea or exiting the market entirely before patent expiry continue.With the government’s system reform, structural barriers that global pharma long cited have now been meaningfully reduced.It’s time for companies to follow through and demonstrate concrete actions to broaden Korean patients' access to new drugs — such as expanding indications, reapplying for reimbursement, and reconsidering delayed launches —measures they have previously postponed.For the term ‘Korea passing’ to cease appearing in headlines, policy reform alone is not enough.Both the government and companies must demonstrate clear actions, viewing Korean patients through the lens of international standards and prioritizing treatment accessibility.
- InterView
- [Reporter’s View] Is the pricing reform realistic?
- by Hwang, byoung woo Dec 04, 2025 09:13am
- As the government unveils its drug-pricing reform plan, the pharmaceutical industry immediately began preparing its response. Yet many industry voices point out a widening gap between the policy’s stated direction and the realities companies face on the ground.Despite the government’s rationale of “industry restructuring,” concerns are growing over potential repercussions, including reduced R&D investment, weakened manufacturing capacity, and diminished momentum for new drug development. It remains unclear how carefully these impacts were factored into the new framework.This reform plan is reportedly designed based on the principles of streamlining the supply structure, establishing rational drug pricing, and strengthening the government’s fiscal soundness.Specifically, alleviating the burden on insurance finances and eliminating market duplication and inefficiencies are presented as core priorities, with the government emphasizing its intent to increase proactive efforts and support new drug development.But the response from the field tells a different story.A large portion of domestic pharmaceutical companies are already struggling with rising baseline costs—raw materials, labor, and clinical trial expenses. In this context, implementing drug price adjustments simultaneously constrains not only immediate profitability but also future investment capacity.This raises questions about the appropriateness of the policy's pace and intensity.Of course, there is a certain level of consensus on the broader direction of ensuring the sustainability of insurance finances and refining drug price management.However, given that domestic firms lack the robust R&D foundations owned by multinational companies, the reform is widely seen as a disproportionate burden on the local industry.Over the past several years, the Korean government has repeatedly positioned pharmaceuticals and biotech as a key future growth engine and implemented various support policies.Yet the latest pricing overhaul may likely conflict with companies’ mid- to long-term investment plans. Critics argue that prioritizing short-term fiscal stability may ultimately weaken Korea’s long-term industrial competitiveness.The pharmaceutical and biotech industries operate based on uncertainties, such as long-term R&D, potential failures, and technological advancements, rather than short-term profits.Therefore, drug pricing policy inherently carries significance beyond simple price adjustments —it can reshape the industry’s underlying dynamism.The intent behind the reform is understandable in some respects. But if the pace and magnitude of implementation are not calibrated properly, companies may be forced to reduce future R&D investment as their first line of survival.Consequently, a cautious approach is needed, as this could erode the industry's growth capacity and disrupt efforts to secure technological competitiveness. How to strike a delicate balance between government systems and the national strategy of fostering the industry as a future growth engine will be the key challenge moving forward.
- InterView
- Anzupgo to address the unmet needs in chronic hand eczema
- by Eo, Yun-Ho Nov 18, 2025 06:13am
- Professor Sonja Molin, Division of Dermatology, Department of Medicine at Queen Since their emergence, JAK inhibitors have rapidly expanded their therapeutic footprint. Initially introduced as the first oral option in rheumatoid arthritis, a field previously reliant solely on injections, JAK inhibitors have since taken a pivotal role across the spectrum of autoimmune diseases, including ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, and Crohn’s disease. In this context, JAK inhibitors are now breaking yet another barrier in disease management by shedding even the notion of being an ‘oral formulation’ and entering the market as topical ointment formulations, ushering in a new paradigm shift. In September, the Ministry of Food and Drug Safety granted marketing authorization for Anzupgo (delgocitinib), a treatment for chronic hand eczema (CHE). Specifically, Anzupgo is indicated for the topical treatment of“moderate-to-severe chronic hand eczema in adults who have an inadequate response to, or for whom treatment with topical corticosteroids is not advisable.” As a non-steroidal, topical, pan-JAK inhibitor, Anzupgo inhibits the activation of the JAK-STAT cellular signaling pathway, known to play a key role in the manifestation of hand eczema. Until now, treatment options for chronic hand eczema have been limited, with strong topical corticosteroids commonly used as first-line therapy. However, its long-term use carries risks of various side effects, including skin barrier damage, skin atrophy, and telangiectasia. Dailypharm met with Dr. Sonja Molin, Professor of Dermatology at Queen's University, to discuss the clinical value and therapeutic potential of Anzupgo, the first topical JAK inhibitor for CHE. Anzupgo cream-What is chronic hand eczema, and what is its prevalence? CHE is one of the most common skin conditions affecting the hands, and a large proportion of cases progress to chronic disease. CHE is known to affect approximately 1 in 10 adults worldwide. This disease causes significant functional, occupational, and psychological burdens, significantly reducing patients' quality of life. Approximately 70% of patients with severe CHE experience difficulties performing daily activities, which directly impacts their employment and income. As a result, early diagnosis and appropriate treatment are paramount to effectively reduce the disease burden for these patients. Therefore, raising awareness about CHE and expanding active treatment approaches are urgently needed. Many patients only visit general practitioners rather than dermatologists, meaning a significant number of cases are not fully reflected in official statistics. Consequently, the true prevalence of hand eczema is likely much higher than current estimates. -Chronic hand eczema is known to be morphologically diverse. Which subtypes primarily occur? CHE is a heterogeneous disorder influenced by multiple factors and manifests in various forms. According to the 2022 European guidelines, CHE is categorized into etiological subtypes and clinical subtypes. In practice, overlapping subtypes are quite common, with irritant contact dermatitis and allergic contact dermatitis being common causes. Clinical subtypes like bullous or hyperkeratotic hand eczema also require careful treatment. -Does Anzupgo show efficacy across all CHE subtypes? Anzupgo is approved for moderate to severe chronic hand eczema in adults who do not respond to or are not suitable for topical steroid therapy. Results from the Phase III clinical trial supporting its approval demonstrated that delgocitinib cream showed broad therapeutic responsiveness across all CHE subtypes. Mechanistically, Anzupgo not only provides anti-inflammatory effects but also helps restore the damaged skin barrier, making it suitable for treating irritant, allergic, vesicular, and hyperkeratotic subtypes. Clinically, patients with thick, severe hyperkeratotic lesions may exhibit slower treatment response. However, CHE is a chronic condition requiring long-term management, so continued treatment should be considered with expectations for gradual improvement. -What limitations exist with previous CHE treatments, and how does Anzupgo differ? As a dermatologist, I have long felt that existing treatment options for CHE are inadequate. For example, topical corticosteroids are internationally recommended as first-line therapy, but repeated long-term use often leads to diminished efficacy and local adverse effects, which are clear limitations. Alitretinoin is the only oral medication approved specifically for CHE and is effective for symptom control. However, concerns regarding teratogenicity restrict its use in women of childbearing potential, and routine lab monitoring is required, limiting its broader use. This unmet need means the disease burden associated with patients' symptoms remains a challenge that needs to be addressed. Therefore, the arrival of Anzupgo, a topical therapy with a novel mechanism and clinically proven efficacy and safety, is extremely welcome. - You have real-world experience prescribing Anzupgo. How do clinical outcomes compare with trial data? Having participated in the DELTA study, the pivotal clinical trial for Anzupgo, I was therefore already familiar with its efficacy and safety profile. As a dermatologist treating patients with CHE, my primary concern was whether the efficacy and safety profile demonstrated in clinical trials would translate identically to real-world patient outcomes. In conclusion, Anzupgo met these expectations and, in some cases, demonstrated even superior efficacy in real-world practice. Notably, it showed excellent responsiveness in the bullous subtype of CHE, where response to existing medications was often poor. Furthermore, the results of the DELTA FORCE study, which directly compared Anzupgo with the oral agent alitretinoin, are also impressive. It was surprising that delgocitinib cream demonstrated statistically significant clinical results compared to alitretinoin in the primary endpoint (change in HECSI score at Week 12 from baseline) and all other efficacy parameters. -When should patients previously treated with topical steroids consider switching to Anzupgo? If the response to topical corticosteroids is inadequate or relapses are frequent, the physician should consider other treatment options as early as possible. Since its approval in Germany last September, the use of Anzupgo has steadily increased. Awareness of delgocitinib cream is gradually growing among both healthcare professionals and patients, and overall treatment satisfaction is high.
- InterView
- ADCs rise to become SOC in key solid tumors
- by Son, Hyung Min Nov 06, 2025 06:32am
- Major antibody-drug conjugates (ADCs) are rapidly becoming standard-of-care (SOC) therapies across solid tumors, reshaping treatment paradigms. Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has displaced Kadcyla (trastuzumab emtansine) as the new SOC in HER2-positive breast cancer. Enhertu is also validating potential as a first-line therapy in combination with the targeted therapy Perjeta (pertuzumab). In urothelial carcinoma, Astellas’ Padcev (enfortumab vedotin) is rising rapidly. Padcev monotherapy has already become SOC in second-line settings, and in first-line disease, Padcev + Keytruda (pembrolizumab) is now a preferred regimen in the NCCN guidelines, overtaking Bavencio (avelumab) + chemotherapy as the dominant option. Merck's existing immuno-oncology drug ‘Bavencio (avelumab)’ + chemotherapy, has been used as the SOC for urothelial carcinoma, but the introduction of Padcev significantly increased the likelihood of this position changing. Enhertu aims to become SOC across HER2-mutated solid cancers Enhertu is a next-generation ADC composed of a monoclonal antibody that has the same structure as trastuzumab, which binds to receptors overexpressed on cancer cells and a highly potent Topo I inhibitor payload, linked via a tumor-selective cleavable linker. ADCs are anticancer drugs manufactured by linking an antibody that binds to a specific target antigen on the surface of cancer cells with a drug that has cell-killing (cytotoxic) properties (payload). ADCs act selectively on cancer cells by using the selectivity of antibodies to their targets and the killing activity of drugs to increase therapeutic efficacy while minimizing side effects. In a head-to-head study, Enhertu nearly doubled progression-free survival (PFS) compared to Kadcyla. Enhertu and Kadcyla use the same trastuzumab backbone but with a different microtubule inhibitor payload. Unlike Kadcyla, which uses a microtubule inhibitor monomethyl auristatin E (MMAE) as its payload, Enhertu utilizes a topoisomerase I inhibitor. This difference led to a starkly contrasting efficacy. As a result, companies in Korea and abroad are actively pursuing ADC development using topoisomerase I inhibitor payloads. Among later-stage drugs, ‘Datroway (datopotamab)’ and ‘Trodelvy (sacituzumab govitecan)’ have adopted topoisomerase I inhibitor payloads. However, Enhertu's ambition extends beyond second-line HER2-positive breast cancer. It has shown potential not only as the second-line SOC for HER2-positive breast cancer but also as a first-line therapy, demonstrating efficacy across various solid tumors. Enhertu has established its efficacy in combination with Roche's Perjeta. Perjeta is one of the drugs used in the so-called ‘THP regimen (taxane + Herceptin + Perjeta)’, which serves as the standard first-line treatment for HER2-positive breast cancer. The Phase III DESTINY-Breast09 trial compared the efficacy and safety of Enhertu plus Perjeta versus THP therapy in 1,157 patients with previously untreated HER2-positive breast cancer. Patients were randomized in a 1:1:1 ratio to the Enhertu + placebo group (387 patients), the Enhertu + Perjeta group (383 patients), or the THP therapy group (387 patients). The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR). Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety. During a median follow-up of 29 months (interim data cutoff February 26, 2025), the PFS in the Enhertu+Perjeta group was 40.7 months, longer than the 26.9 months in the THP therapy group. The ORR was 85.1% in the Enhertu+Perjeta group and 78.6% in the THP therapy group. DOR was 39.2 months in the Enhertu+Perjeta group and 26.4 months in the THP therapy group, showing a difference. The OS data were immature at the time of cutoff. In addition to breast cancer, Enhertu has been approved for gastric cancer and non-small cell lung cancer. In April last year, it also received accelerated approval from the U.S. Food and Drug Administration (FDA) for all HER2-positive solid tumors that lack alternative treatment options. Its potential is now being explored in cancers with limited treatment options, such as colorectal cancer and biliary tract cancer. Padcev seeks to become first-line SOC in urothelial carcinoma in combination with an immune-oncology drug Astellas’ Padcev is pushing toward first-line SOC in combination with Keytruda. That position had long been held by Bavencio plus chemotherapy. Bavencio is a relatively mild agent and has advantages for use in elderly patients and long-term administration. But Padcev’s clinical results are being regarded as groundbreaking. In the Phase III EV-302/KEYNOTE-A39 study, Padcev + Keytruda achieved a median overall survival (OS) of 31.5 months in previously untreated urothelial carcinoma patients. This represented a significant difference compared to the 16.1 months observed in the control group(chemotherapy). Although differences existed in the control group and clinical design, the median OS for the Bavencio maintenance therapy arm was 29.7 months. This represents an extension of over 9 months compared to the 20.5 months observed in the control group receiving maintenance therapy alone. However, patients were randomized after receiving approximately 4 months or more of prior treatment (4-6 cycles) with gemcitabine plus cisplatin or carboplatin combination therapy. Accordingly, the NCCN guidelines recommend Padcev + Keytruda as a Category 1 first-line therapy in locally advanced or metastatic urothelial carcinoma. For second-line or later settings, Padcev monotherapy is the preferred therapy, and for third-line or later, it is recommended as a Category 1 preferred therapy. Padcev also demonstrated efficacy in muscle-invasive bladder cancer, where radical cystectomy is the SOC, presenting new possibilities. The combination therapy of Padcev plus Keytruda demonstrated statistically significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response rate (pCR) compared to radical cystectomy+pelvic lymph node dissection (RC+PLND) alone. This study is the first randomized Phase III trial demonstrating a clear survival benefit from pre- and post-operative combination therapy in patients with cisplatin-ineligible, muscle-invasive bladder cancer who are eligible for surgery. Padcev is an ADC targeting Nectin-4, composed of a Nectin-4-specific fully human monoclonal antibody and MMAE. Padcev chose MMAE as the payload due to its synergistic effect with PD-1. Nectin-4 is overexpressed in urothelial carcinoma cells compared to normal tissue, providing high selectivity for cancer cells. After binding, it enters the cell and releases MMAE to induce cell death. When combined with PD-1 inhibitors like Keytruda, the cytotoxicity of MMAE synergizes with the immune activation from PD-1 inhibition, maximizing antitumor activity. Despite its aggressive nature, metastatic urothelial carcinoma has had no first-line treatment options beyond chemotherapy for 30 years, creating a significant unmet need. Before Padcev monthearpy, the response rate to immune-oncology drugs was only 13-28% regardless of PD-L1 status, and a significant number of patients experienced disease progression within 3 months of treatment. Therefore, whether Padcev + Keytruda becomes the new standard of care (SOC) in the first-line treatment space is now a matter of intense interest. Recently, this combination therapy cleared the first hurdle for reimbursement in Korea by passing the Cancer Disease Deliberation Committee, taking a significant step closer to commercialization in Korea.
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- "GI Innovation challenges melanoma"
- by Hwang, byoung woo Oct 21, 2025 06:18am
- GI Innovation is accelerating its entry into the global market. The company unveiled clinical data for its new immunotherapy drug candidate, 'GI-102,' at the ESMO Congress 2025 (European Society for Medical Oncology). GI-102 is drawing attention for its potential to overcome resistance, as it showed clinical improvement, including tumor shrinkage of more than half, even in melanoma patients who did not respond to PD-1 antibody monotherapy. Based on the latest results, the company has strategized to expand collaboration with global pharmaceutical companies for joint clinical trials and aims for first-line treatment for melanoma. DailyPharm met with Myoung Ho Jang, CEO of GI Innovation, and Nari Yun, Director, at the ESMO Congress 2025 to hear about the significance of the GI-102 poster presentation and the company's future strategy. (from left) Na Ri Yun, Executive Vice President (Clinical Dev & Strategy) and Myoung Ho Jang, CEO of GI Innovation "Demonstrated activity in patients refractory or resistant to immunotherapies…potential to overcome Keytruda resistance" The new drug candidate GI-102 is a fusion protein developed using the company's proprietary "Immune-cytokine" platform. It is structured to maintain the anti-cancer immune activation function of IL-2 (Interleukin-2) while reducing toxicity by combining it with the immunomodulatory protein CD80. It works by a differentiated mechanism that directly activates immune cells and suppresses regulatory T-cells (immunosuppressive cells), thus being assessed as an innovative candidate that can compensate for the limitations of existing PD-1 antibodies. According to the GI-102 poster presentation at ESMO Congress 2025, the drug showed significant anti-cancer activity in a combination trial targeting patients refractory or resistant to PD-1 antibodies. In the initial combination trial, 10 melanoma patients who were refractory to PD-1 antibodies, the combination of GI-102 and Keytruda (pembrolizumab) recorded an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70%. Notably, a case was presented where a patient whose disease had progressed just two months after initial Keytruda treatment achieved a partial response (PR), with the tumor shrinking by approximately 59%, after the GI-102 combination therapy. In this case, the tumor reduction (cPR, -59%) and progression-free survival (PFS) of 3.9 months were observed when GI-102 was combined with the same drug backbone. Na Ri Yun, Executive Vice President of GI Innovation (Clinical Dev & Strategy), explained, "The fact that the tumor shrank by more than half in a patient who did not respond to PD-1 antibody monotherapy signifies the potential to overcome refractoriness," and added, "The key finding is that GI-102 dramatically increases the number of immune cells (lymphocytes) that determine the response rate of immunotherapies." The GI-102 combination group also showed an increasing trend in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, as treatment progressed. Yun mentioned, "We confirmed a clear increase in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, following the GI-102 combination," and added, "When the number of immune cells increases, there are more targets for the PD-1 antibody to bind to, which ultimately strengthens the anti-cancer effect." Notably, no dose-limiting toxicities (DLT) were observed in this combination trial. Most adverse events, such as fever and chills, were mild (Grade 1-2). Although elevated liver enzymes occurred transiently in some patients during the first treatment cycle, they recovered to the normal range. The company explained that "global pharmaceutical companies also assessed these to be manageable through meetings." Yun said, "The frequency of side effects was significantly low compared to conventional IL-2 class drugs, and patients tolerated the treatment well." She added, "We have obtained very positive data in terms of safety." Myoung Ho Jang, CEO of GI Innovation, said, "This data confirmed that GI-102 monotherapy shows activity comparable to global blockbuster immunotherapies," and assed that "The combination therapy was confirmed to induce a response even in patient populations that existing PD-1 antibodies could not reach." Jang added, "GI-102 is garnering high interest from global pharmaceutical companies because it is an IL-2-based immunocytokine that suppresses regulatory T-cells." Active discussions with global pharma..."A head-to-head challenge in first-line melanoma treatments" GI Innovation engaged in discussions with global pharmaceutical companies at the conference regarding collaborative clinical trials for first-line melanoma treatment. Currently, PD-1 antibodies like Keytruda and Opdivo (nivolumab) are approved as first-line monotherapies for melanoma. Jang said, "We are having positive discussions with global pharmaceutical companies here at ESMO 2025," and added, "We are reviewing a randomized clinical design to 'head-to-head' compare the efficacy of the GI-102 combination effect against PD-1 monotherapy." Yun added, "Melanoma is the only cancer type where PD-1 monotherapy is the standard of care. Proving the superiority of GI-102 here will increase its potential for expansion into other solid tumors." The fact that the company is considering a direct comparison clinical trial against a first-line monotherapy is evidence of its confidence in the results. Notably, GI Innovation stated that it is considering developing GI-102 not merely as a technology transfer (L/O) but as a co-clinical/co-commercialization model with global pharmaceutical companies. Jang stressed, "While we are in discussions for the technology transfer of GI-101A, we prefer a model where the company retains certain rights and co-develops GI-102 with a global pharmaceutical company," and stressed, "Our goal is to increase long-term value through a direct commercialization structure, creating direct revenue rather than just royalty income." Yun added, "We favor a partnership structure where the company proactively secures rights so as not to be swayed even if a global pharmaceutical company's internal priorities change." In conclusion, the analysis suggests that the discussions held at ESMO Congress 2025 confirmed GI-102's competitiveness in the global market. Finally, Jang said, "Although we are starting with melanoma, we expect a rapid expansion into other solid tumors through off-label use as clinical evidence accumulates," and added, "The conference provided us with confidence that GI-102 possesses genuine competitiveness in the global market."
- InterView
- "New landscape in DLBCL trt…Columvi·Polivy's bigger role"
- by Hwang, byoung woo Oct 10, 2025 06:06am
- Diffuse large B-cell lymphoma (DLBCL) has been known to lack new treatment options besides rituximab (MabThera) for over 20 years. Approximately one-third of DLBCL patients who undergo existing treatments (primarily R-CHOP) experience relapse or become non-responsive, and the second-line treatment has been limited to intensive chemotherapy and autologous stem cell transplant. However, the treatment paradigm is changing as innovative treatments, including antibody-drug conjugate (ADC), bi-specific antibodies, and CAR-T cell therapies, have emerged recently. During the meeting with DailyPharm, Professor Gareth Gregory of Monash University in Australia emphasized the role of treatments with new mechanisms, such as Polivy and Columvi, for older adults or patients who failed previous therapies. DLBCL still lacks treatments for older adults or transplant-ineligible patients…second-line treatment alternatives are needed Professor Gareth Gregory of Monash University in AustraliaAccording to Professor Gregory, the highest unmet needs for DLBCL are the second-line treatment. Exiting treatment data show that approximately one-third of all patients with DLBCL experience disease progression despite undergoing first-line treatments. To date, treatment options have been limited to intensive chemotherapy and autologous stem cell transplant. Professor Gregory said, "A significant proportion of DLBCL patients globally are elderly, aged 68 or older, and often have comorbidities, thus most of them are ineligible for autologous stem cell transplant," and added, "Given the high relapse rate characteristic of lymphoma, the response rate for patients receiving CAR-T or autologous stem cell transplant treatment in the second line is only about 21%, highlighting a significant need for more effective and safer therapeutic options." For this reason, interest has grown in treatments with new mechanisms, like bispecific antibodies. The need for monotherapy or combination therapy options, particularly for elderly patients or those who have failed previous treatments, is persistently being raised. Among the therapies currently driving a paradigm shift in DLBCL treatment are Polivy (polatuzumab vedotin) and the combination therapy of the bispecific antibody Columvi (glofitamab) with Gemcitabine and Oxaliplatin (GemOx). Particularly in the first-line setting, Polivy in combination with R-CHP is emerging as the new standard of care, replacing the traditional R-CHOP. For relapsed/refractory patients, the combination of the bispecific antibody Columvi and GemOx is gaining attention as a powerful alternative that shows long-term efficacy. Regarding this, Professor Gregory emphasized that the core of DLBCL treatment is not the 'effectiveness of a single agent,' but the 'design of the entire treatment journey.' For example, this involves a strategy in which Polivy reduces the risk of relapse in the first line, and Columvi increases the complete response rate in the second-line treatment setting, thereby extending treatment continuity. Professor Gregory said, "Polivy reduces the risk of relapse and death in first-line treatment, and Columvi offers the potential for long-term survival for relapsed patients," and added, "Both treatments are evolving to improve the patient's entire treatment journey." Polivy drives changes to the first-line setting...increased expectation of expanded reimbursement Polivy is evaluated as a key therapy for reducing the risk of recurrence associated with the conventional R-CHOPregimen and for improving long-term patient survival. Fortunately, it recently passed the Cancer Disease Review Committee (CDRC) in Korea, raising expectations for expanded reimbursement for first-line treatment. The 5-year follow-up data from the POLARIX study showed that the Polivy + R-CHP combination therapy improved both progression-free survival (PFS) and overall survival (OS) compared with conventional R-CHOP, and the rate of transition to subsequent treatments was significantly lower. Professor Gregory said, "Polivy combination therapy has been included in the first-line recommendations in guidelines in multiple countries, including Australia," and added, "Tolerability was similar to or better than R-CHOP, and we confirmed a long-term trend of reduced risk of relapse and death." Furthermore, Professor Gregory also pointed out that, given the characteristic of DLBCL, where the risk of relapse increases sharply if complete response is not achieved in the first line, the Polivy combination therapy is significant for its role in reducing treatment burden and medical resource consumption. He said, "Polivy combination therapy is significant not only for its treatment results but also for the efficiency of medical resources," and added, "Reducing relapse shortens the complex treatment process that leads to high-intensity therapies, and can also reduce patient hospitalization time, medical costs, and the loss of social productivity." Columvi offers long-term survival potential for relapsed patients...reimbursement remains a hurdle Meanwhile, in the second-line setting, Columvi is showing new possibilities. Columvi, a bispecific antibody, targets T cells and B cells simultaneously, achieving a high response rate even in relapsed/refractory patients with reduced chemotherapy response. In the 2-year follow-up analysis of the STARGLO Phase 3 trial, the Columvi + GemOx combination group had a 4-fold increase in PFS (13.8 months vs. 3.6 months) and a more than 2-fold improvement in complete response rate (58%) compared with the rituximab + GemOx group. Notably, 82% of patients who achieved remission maintained their response for at least 1 year, demonstrating the potential for long-term survival despite the fixed duration of therapy. Columvi's step-up dosing strategy is highlighted as a clinical feature that secures safety by minimizing immune-related side effects. Professor Gregory said, "Bispecific antibodies carry the risk of Cytokine Release Syndrome (CRS) due to immune system activation, but Columvi can be managed safely through step-up dosing and pre-treatment," and emphasized, "Columvi has the biggest advantage in that it is an 'off-the-shelf' therapy, meaning it can be administered immediately after diagnosis." He assessed, "Some patients in the STARGLO trial have maintained a long-term response for over four years, and for patients ineligible for CAR-T or transplant, the Columvi combination therapy offers a possibility of cure." Despite these therapeutic effects, the issue of utilization in Korea remains a reimbursement barrier. Polivy was stuck in a non-reimbursed state for five years after its 2020 approval, and Columvi also failed to pass the CDRC in December last year. Although Polivy initiated its first step toward reimbursement this year with discussions for first-line coverage, Columvi is still waiting for reimbursement listing for its second-line indication. Professor Gregory mentioned, "Effective treatment is meaningless if it is not delivered to the patient," and added, "Drugs with better accessibility and tolerability should realistically be reimbursed, especially compared to high-cost therapies like CAR-T, which are restricted to limited facilities." According to Professor Gregory, Australia has already approved reimbursement for the combination therapy of Columvi + GemOx for autologous stem cell transplant-ineligible patients, using the same criteria as those used in the clinical trial patient population. Finally, he said, "The ultimate goal of lymphoma treatment is to create patient-centered outcomes. If a treatment has sufficient accumulated clinical data, it should be applied to the field quickly," and added, "Institutional support is needed so that patients can receive the best care more safely and rapidly."
- InterView
- "Gilead-Kite will lead the trt landscape for DLBCL in KOR"
- by Hwang, byoung woo Sep 10, 2025 06:12am
- With the approval of the CAR-T cell therapy Yescarta (axicabtagene ciloleucel) in Korea, a shift in the treatment landscape for Diffuse Large B-cell Lymphoma (DLBCL) is anticipated. Analysis suggests that an innovative therapeutic option that has demonstrated higher cure rates and improved survival compared to existing second-line treatments is expected to provide a new option for patients in Korea. Gilead Sciences and Kite Pharma plan to use Yescarta's Korean approval to strengthen their cooperation with Korea's health authorities and medical institutions, focusing on addressing the unmet needs of DLBCL patients. DailyPharm met with Diego Santoro, Head of the International Region for Kite Pharma (a Gilead Sciences company), to hear about the company's specific plans. Diego Santoro is an expert who has led the commercialization and expansion of access for CAR-T cell therapies in key countries such as Japan, Korea, and Brazil, with over 25 years of leadership experience at global pharmaceutical companies. Yescarta's Milestone in DLBCL Treatment..."Became a Key Treatment Option" Diffuse Large B-cell Lymphoma (DLBCL) is a very rapidly progressing disease, with approximately 40% of patients who receive first-line treatment experiencing a relapse. Previously, the average survival period after second-line treatment was only about 6 months, but with the introduction of CAR-T therapies, survival rates have significantly improved. Diego Santoro, Head of the International Region for Kite PharmaThrough one of the world's largest clinical studies, Yescarta demonstrated that approximately 41% of patients survive for over 5 years. Yescarta is currently approved in over 40 countries, and its reimbursement has been secured in numerous countries based on its therapeutic efficacy and financial feasibility, expanding patient access. From this perspective, Yescarta is also expected to become an important therapeutic option that addresses unmet needs in Korea. Diego Santoro explained, "Korean medical professionals were well-informed about Yescarta's clinical data even before its approval, and the demand for its introduction was high." He added, "The biggest differentiation factor is that it allows patients to start treatment at an earlier stage, which improves prognosis and increases the possibility of a cure. The trend in clinical practice is already shifting, with patients who were previously considered for third-line therapy now being treated at the second-line stage." In other words, by administering CAR-T earlier at the second-line treatment stage, rather than waiting until the third-line as in the past, it is possible to suppress the cancer early and aim for a cure. For Yescarta, which has already proven its efficacy in the global market, to secure influence in Korea, three major challenges exist: access, supply, and competing treatments. Among these, entry into the national health insurance system will be the biggest hurdle for expanding access. Regarding this, Santoro said, "Yescarta's reimbursement application was submitted at the end of August, immediately following its domestic approval in Korea. We are currently expediting the submission of all relevant documents and are ready to enter into full-scale discussions with the government," and added, "Gilead and Kite Pharam will focus on improving patient access by collaborating closely with the government, as well as with Korean medical professionals and patient organizations." And added, "We are fully aware of the concerns regarding the drug's price and institutional challenges. During the negotiation process, we plan to present a compelling case about Yescarta's differentiated clinical value as a second-line therapy and how earlier treatment improves patient outcomes and the possibility of a full recovery." "Quickly applying for reimbursement...patient access is the main priority" Another task is the supply issue. Currently, both the reimbursed CAR-T therapy Kymriah and Yescarta require harvesting the patient's cells in Korea, sending them to the U.S. for manufacturing, and then bringing the finished product back to Korea. There is a concern that this process can delay treatment, which is critical for CAR-T patients, and potentially worsen their prognosis. Regarding this, Santoro said, "The speed of supply is the priority for treatment outcomes with CAR-T therapies, so we prioritize it above all else." He added, "Based on the experience accumulated from treating over 31,000 patients worldwide, Gilead and Kite Pharma have achieved a CAR-T therapy manufacturing success rate of over 96%, which is the highest in the industry, and a vein-to-vein (V2V) time that is among the fastest globally." V2V refers to the time from a patient's leukocyte collection to the infusion of the therapy. The company maintains a supply time of less than 30 days in Asia and plans to guarantee the same volume for Korea. He said, "We ensure that the collected cells are not frozen and arrive at the manufacturing site within 72 hours. In the actual supply process, we always secure more than two backup flights to prevent any disruption to patient treatment." He stated, "We know that a difference of even 1-3 days can have a significant impact on a patient's treatment outcome, so our goal is to provide the therapy as quickly as possible." Regarding competition with new options like recently emerged bispecific antibodies, Santoro emphasized, "In most countries, bispecific antibodies are approved as third-line therapies after CAR-T, and the guidelines from major academic societies and institutions also recommend the use of CAR-T therapies in early stages." Aim to Become a Hub for CAR-T Therapy in Asia Santoro views that Yescarta's approval in Korea represents not just a commercial entry but also a significant medical and scientific milestone. He said, "Korea is a competitive country with excellent medical infrastructure and highly skilled medical professionals. The swift approval of Yescarta is expected to bring a positive change to the patient treatment environment, alongside existing anti-cancer drugs." Kite Pharma has a strong history of collaboration with Korea's medical institutions and health authorities, as it highly values Korea's capabilities. Based on this foundation, Kite Pharma has presented a blueprint to develop Korea into a hub for CAR-T therapy in Asia by investing in training medical professionals and strengthening hospital capabilities. Finally, Santoro stated, "The approval of Yescarta as a second-line therapy in Korea is an important starting point that will significantly change the patient treatment environment." He added, "Based on our global experience, we will provide trustworthy and innovative treatment options to Korean patients."
