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- 2026-06-06 10:09:39
- Company
- Vyloy receives DREC review for reimbursement
- by Eo, Yun-Ho Jun 04, 2026 09:39am
- The reimbursement process for the gastric cancer targeted therapy Vyloy (zolbetuximab) has made significant progress.According to industry sources, Vyloy, Astellas Pharma Korea’s targeted therapy for Claudin 18.2-positive gastric cancer, passed the Health Insurance Review & Assessment Service (HIRA)'s Pharmacoeconomic Evaluation Subcommittee on May 22 and is scheduled to be reviewed by the Drug Reimbursement Evaluation Committee today (June 4).This development appears to have renewed momentum for a reimbursement process that had stalled after the drug passed the Cancer Drug Review Committee in October of last year.Approved in Korea in September 2024, Vyloy initially failed to pass the Cancer Drug Review Committee during its first reimbursement application in February last year. The company immediately resubmitted its application and ultimately secured approval. However, subsequent delays in the reimbursement process have led to expectations that final listing approval may still take considerable time.Vyloy is the world's first approved Claudin 18.2-targeted therapy. It is an immunoglobulin monoclonal antibody that selectively binds to Claudin 18.2, a protein expressed and exposed in gastric cancer cells.The Phase III SPOTLIGHT trial, which served as the basis for approval, showed that the combination of Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) achieved a median progression-free survival (mPFS) of 10.61 months, compared with 8.67 months in the placebo group. Median overall survival (mOS) was 18.23 months versus 15.54 months, respectively.Similarly, in the GLOW trial, the combination of Vyloy and CAPOX (capecitabine plus oxaliplatin) achieved an mPFS of 8.21 months, reducing the risk of disease progression or death by approximately 31%.Professor SunYoung Rha of Yonsei Cancer Center commented,"Approximately 90% of patients with metastatic gastric cancer are HER2-negative, creating an urgent need for therapies targeting new biomarkers. Given that roughly 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the introduction of Vyloy, which selectively binds to Claudin 18.2, offers a new therapeutic possibility."Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines published in the Journal of Gastric Cancer (JGC) on January 6, 2025, recommending Vyloy at the highest level for first-line treatment of patients who are HER2-negative and Claudin 18.2-positive.Vyloy has also been listed as a standard treatment option in Japanese gastric cancer treatment guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. In addition, it has been listed as a Preferred Regimen in the U.S. National Comprehensive Cancer Network (NCCN) guidelines, rapidly establishing itself as the global standard-of-care treatment for gastric cancer.
- Policy
- Novo Nordisk discontinues Victoza Pen supply in Korea
- by Lee, Tak-Sun Jun 02, 2026 08:55am
- Novo Nordisk Korea will discontinue the supply of its type 2 diabetes treatment, Victoza Pen 6 mg/mL (liraglutide), in the Korean market. The move follows the reimbursement listing of its successor product, Ozempic (semaglutide), in February and appears to be part of a broader portfolio optimization strategy aimed at replacing older-generation therapies with next-generation products.According to industry sources, Novo Nordisk Korea recently decided to discontinue Victoza Pen under its product portfolio integration and enhancement strategy and officially reported the decision to the Ministry of Food and Drug Safety on June 1.Victoza Pen, which was approved in Korea in 2010, is a first-generation GLP-1 receptor agonist for diabetes. Unlike Victoza, which required daily administration, Ozempic, which recently secured reimbursement coverage, demonstrated superior glycemic control and weight-loss benefits despite requiring only once weekly administration. Under pressure to make way for newer and more effective products, Novo Nordisk appears to be accelerating its portfolio transition in earnest with Ozempic’s inclusion in the national health insurance reimbursement.The company emphasized that extensive measures have been established to ensure that patient care is not disrupted by the discontinuation. A company official stated, “Supply will be discontinued as part of our portfolio integration efforts to provide stable treatment options to a greater number of patients. We will provide transition guidelines until supplies are completely cut off to ensure continuity of care for existing patients."The representative added, “We will carefully manage existing inventory until stocks are exhausted and maintain close communication with healthcare professionals to prevent any impact on patient treatment. Based on current inventory depletion forecasts, the likelihood of a sudden supply shortage or widespread stockout situation is low.”Novo Nordisk plans to recommend Ozempic Prefilled Pen as an alternative treatment option for patients currently receiving Victoza. The company noted, “Treatment transitions will be carried out appropriately based on healthcare professionals’ clinical judgment and each patient’s individual health status.”The medical community largely views the discontinuation as an expected development. One endocrinology professor at a university hospital commented, “The market is currently transitioning from once-daily liraglutide (Victoza) to once-weekly semaglutide (Ozempic), as it offers improved convenience and clinical utility. Since Ozempic entered the reimbursement system earlier this year, I believe the transition will be relatively smooth, as the patients’ financial burden will also be reduced.”
- Product
- Mounjaro 12.5 mg and 15 mg land in Korea
- by Kim JiEun Jun 02, 2026 08:55am
- The final high-dose formulations of the obesity treatment Mounjaro (tirzepatide) are set to enter the Korean market. With the completion of the phased expansion of dosage options that has been underway since the launch of the low-dose product last year, expectations are rising among obesity and diabetes treatment prescribers for gaining broader prescribing options.Lilly Korea announced that it plans to launch Mounjaro single-use prefilled pens in 12.5 mg and 15 mg strengths on June 10.Mounjaro was first launched in 2.5 mg and 5 mg formulations in August of last year, followed by 7.5 mg in October and 10 mg in November. The introduction of the new high-dose products completes the supply lineup for all domestically approved dosage strengths.The timing of the high-dose launch has been the subject of significant speculation among healthcare professionals and pharmaceutical distributors. Medical institutions specializing in obesity treatment have reportedly received numerous patient inquiries regarding the availability of high-dose prescriptions, and distributors have also been closely monitoring launch schedules since last month.As Mounjaro has emerged as one of the leading competitors to Wegovy in the rapidly expanding obesity treatment market, the availability of higher-dose products has been regarded as a major issue of market interest.Lilly stated, “Clinical results showed progressively greater weight-loss effects at higher doses. In the SURMOUNT-1 study involving adults with obesity, weight reduction at week 72 reached 16% in the 5 mg group, 21.4% in the 10 mg group, and 22.5% in the 15 mg group.”Industry observers believe that even if the product is launched on the 10th, it will take some time for the higher-dose products to actually reach the market.One pharmaceutical distribution executive explained, “While orders are expected to be accepted starting on the 10th, considering the allocation of inventory quantity confirmations, wholesale inventory is likely to arrive around 20 days later.”As a result, widespread prescribing of the high-dose formulations is expected to begin sometime after mid-June.Some observers have expressed concerns that the introduction of higher-dose products could lead to dose-splitting practices similar to those reported with Wegovy. However, Lilly emphasized that Mounjaro’s product design makes such misuse considerably more difficult.A Lilly representative explained, “Multi-dose pens allow patients to adjust doses themselves, which may have enabled some degree of dose splitting. In contrast, Mounjaro uses a single-use prefilled pen that is discarded after one injection, making it difficult for patients to arbitrarily alter the dose.”
- Company
- Oscotec licenses new autoimmune disease drug to a US company
- by Chon, Seung-Hyun Jun 02, 2026 08:55am
- Oscotec announced on June 1st that it has entered into a technology transfer agreement with U.S. biotech company Agios Pharmaceuticals for its autoimmune disease drug candidate, cevidoplenib.Under the agreement, Oscotec will transfer to Agios the exclusive clinical development and global commercialization rights for cevidoplenib. Oscotec will receive a non-refundable upfront payment of $25 million (approximately KRW 37.5 billion) from Agios. Including future development, regulatory, and commercialization milestones based on specific contract terms, the total potential deal value amounts to $665 million (approximately KRW 1 trillion). Following commercialization, Oscotec will additionally receive separate tiered royalties.Cevidoplenib, which was co-discovered and developed through a collaborative research effort between Oscotec and Genosco, is an oral small-molecule novel drug candidate that selectively inhibits spleen tyrosine kinase (SYK). It has been designed to modulate immune-mediated platelet destruction, a primary pathogenic mechanism in immune thrombocytopenia (ITP). Global Phase II clinical trials for both ITP and rheumatoid arthritis (RA) have been completed.The technology fees, including the upfront payment and milestone payments received from Agios, will be distributed between Oscotec and Genosco at 75% and 25%, respectively, in accordance with the terms of a 2016 agreement between the two companies.Agios is a global biopharmaceutical company focusing on the development and commercialization of therapies for rare diseases. Its primary pipeline includes the pyruvate kinase (PK) activator mitapivat. This drug has secured regulatory approvals as a treatment for adult thalassemia in the United States, the European Union, Saudi Arabia, and the United Arab Emirates, and for adult PK deficiency in the United States and Europe.Taeyoung Yoon, CEO of Oscotec, stated, "Following the completion of the Phase II clinical trials for cevidoplenib, we have discussed out-licensing with multiple companies worldwide. We determined that Agios, a global biopharmaceutical company with outstanding expertise in rare hematologic diseases, is the optimal partner to maximize the therapeutic and commercial value of cevidoplenib."
- Policy
- Price negotiations begin for Padcev and Keytruda
- by Jung, Heung-Jun Jun 02, 2026 08:55am
- Astellas Korea’s Padcev (enfortumab vedotin) and MSD Korea’s Keytruda (pembrolizumab) have entered reimbursement price negotiations with the National Health Insurance Service (NHIS) for combination therapy in urothelial carcinoma.At the same time, Keytruda is also under separate negotiations for reimbursement expansion in gastric cancer, placing MSD in a pricing defense dilemma.According to industry sources on June 2, negotiations have begun for Padcev and Keytruda with the NHIS for urothelial carcinoma. In April, Padcev was recognized by the Drug Reimbursement Evaluation Committee (DREC) as being adequate as a first-line treatment for adult patients with locally advanced or metastatic urothelial carcinoma.However, the requirement to negotiate jointly with MSD represented a significant hurdle. Unlike Padcev, Keytruda reportedly joined the negotiations only after considerable deliberation, even after receiving a favorable DREC recommendation.The challenge stems from the fact that when a company participates in reimbursement negotiations for its drug in combination with a drug developed by another manufacturer, it may be forced to repeatedly defend a price that has already been reduced, or may soon be reduced, through prior reimbursement expansions.In January, Keytruda accepted a price reduction following reimbursement expansions across 11 indications, including endometrial cancer, breast cancer, and biliary tract cancer.Subsequently, the company has also pursued reimbursement expansion for Keytruda to dMMR/MSI-H metastatic gastric adenocarcinoma and gastroesophageal adenocarcinoma, following requests from the medical community. The indications passed DREC review in March and are currently under NHIS negotiation.As a result, MSD faces the difficult task of negotiating both the Padcev-Keytruda combination therapy for urothelial carcinoma and reimbursement expansion for gastric cancer during the same period.Industry observers view this as a clear example of the limitations inherent in negotiating reimbursement prices for multi-indication drugs, and stressed the need for an indication-based pricing system.The government is currently reviewing the validity and effectiveness of indication-based pricing. The NHIS plans to complete a research project by the end of this year and may consider implementation if deemed necessary. Factors under review include pricing equity across different cancer types and the administrative burden associated with drug management.Because indication-based pricing remains at the evaluation stage, the key question is whether a breakthrough can be achieved in these negotiations.A Korea MSD official commented, “Although it was not intentional, we ended up conducting the two negotiations simultaneously. We believe this case highlights the need for institutional improvements, such as indication-based pricing. However, since the negotiations have only just begun, further discussion will be necessary.”
- Policy
- "Phase 3 trial waiver·review shortcut"…for K-biosimilar
- by Lee, Tak-Sun Jun 01, 2026 09:04am
- AI-generated imageThe competitiveness of Korean biosimilars is projected to strengthen as the Ministry of Food and Drug Safety (MFDS) pursures regulatory reform that waive the requirement to submit therapeutic confirmatory clinical trial (Phase 3) data during the marketing authorization application process for biosimilars, provided that comparability in quality and non-clinical data is demonstrated.In addition to the 'Biosimilar Review Innovation Plan (reducing the review timeline to up to 240 days)' recently introduced by the MFDS to bolster global competitiveness, this measure is expected to create a powerful synergistic effect, significantly lowering the development burden on domestic biotech companies and accelerating their entry into global markets.A 'Two-Way Synergy' between Phase 3 clinical trial waivers and the 240-Day review In the biosimilar development pipeline, Phase 3 clinical trials have been the greatest hurdle, consuming the most time and requiring astronomical costs. Under the reform plan, developers can be exempted from Phase 3 trials if they successfully demonstrate comparability to the reference product in terms of quality, non-clinical data, and pharmacokinetic (PK) profiles.Notably, this is closely linked to the MFDS's recently announced initiative to reduce the biosimilar review timeline to up to 240 days. When promising biosimilar pipelines, already significantly truncated during the clinical trial stage, are placed on the MFDS's innovative and expedited review track, the overall commercialization cycle is projected to be advanced by several years compared to legacy timelines.Industry experts evaluate that companies will now have a springboard to secure 'first-mover' advantages or early price competitiveness in the global market, not only by reducing clinical development costs but also by minimizing administrative review bottlenecks.The benefits of shortened development timelines and accelerated review speeds will also translate directly to patients. As safe and effective biosimilars capable of substituting for high-cost original biologics are rapidly introduced to the market, the financial burden on patients is expected to ease significantly. It is expected to have a positive impact on safeguarding the fiscal soundness of the national health insurance fund.Through this reform, the MFDS has cleared a path to waive not only Phase 3 clinical trials but also the submission of non-clinical 'repeated-dose toxicity study data,' provided that analytical comparability in terms of quality and pharmacological profiles with the reference product is established. Consequently, companies will be able to gain momentum starting from the early candidate validation phase, substantially accelerating overall pipeline development efficiency.Notably, the public notice ensures that the revised regulations can be applied even to products whose marketing authorization or variation applications have already been submitted to the MFDS and are currently under review at the time of enforcement. The pharma-biotech industry is actively welcoming this 'surprise retroactive application' and the MFDS's consecutive forward-looking regulatory innovations, given that products awaiting approval could have immediate benefits.The MFDS plans to gather opinions from institutions, organizations, and individuals through an administrative notice period ending on June 19, after which the reform plan will be finalized and enacted. Attention is focused on whether the MFDS’s comprehensive deregulation spanning the entire life cycle of development (Phase 3 waiver) and review (240-day reduction) will activate a sluggish investment market and serve as a catalyst to further solidify South Korea’s status as a global biosimilar powerhouse.
- Company
- Yuhan’s gains Phase I approval for returned MASH candidate YH25724
- by Lee, Seok-Jun Jun 01, 2026 09:04am
- Yuhan Corp announced on the 29th that it has received approval from the Ministry of Food and Drug Safety to conduct a domestic Phase I trial of its metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate ‘YH25724.’YH25724 is a novel biologic candidate that combines dual mechanisms targeting fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1). The candidate incorporates Yuhan’s proprietary protein engineering technology together with Genexine’s long-acting antibody fusion platform, HyFc.Preclinical studies have confirmed that the dual action of FGF21 and GLP-1 improves steatohepatitis, exerts anti-fibrotic effects, and reduces hepatocyte damage and liver inflammation.This Phase 1 trial marks the first clinical study of YH25724 in Korea. The study consists of a single-dose part and a 12-week multiple-dose part involving healthy adult participants. Yuhan plans to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).Yeol-Hong Kim, Head of R&D at Yuhan Corp, stated, “We plan to evaluate safety and tolerability across various dose levels in Korean participants and explore preliminary proof-of-concept potential based on pharmacodynamic markers. We plan to start recruitng subjects within this year.”The YH25724 pipeline was originally licensed out to Boehringer Ingelheim in 2019 but was returned in 2025. Since then, Yuhan has resumed in-house development of the candidate.Prior to the return of the program, Boehringer Ingelheim had conducted three Phase I clinical trials evaluating the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of YH25724.
- Company
- Lorviqua shows sustained beneift in 7-year follow up
- by Son, Hyung Min Jun 01, 2026 09:04am
- Pfizer’s non-small cell lung cancer (NSCLC) treatment Lorviqua has demonstrated efficacy in a 7-year follow-up study, confirming its potential for long-term disease control.According to industry sources on the 30th, Pfizer presented 7-year follow-up results from the Phase III CROWN study of Lorviqua (lorlatinib), a targeted therapy for ALK-positive NSCLC, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.ALK-positive NSCLC is a rare genetic subtype accounting for approximately 3–5% of all NSCLC cases. It tends to affect younger patients and is characterized by a high incidence of central nervous system (CNS) metastases during the course of the disease. As a result, long-term disease control and prevention of brain metastases are considered key measures of treatment success.Targeted oral therapies for ALK-positive lung cancer include Pfizer’s first-generation Xalkori (crizotinib), second-generation therapies such as Alecensa (alectinib) and Takeda’s Alunbrig (brigatinib), and third-generation Lorviqua.The global CROWN study directly compared Lorviqua and Xalkori in 296 treatment-naïve patients with advanced ALK-positive NSCLC. Participants were randomly assigned to receive either Lorviqua 100 mg once daily or Xalkori 250 mg twice daily.‘Lorviqua,’ treatment for ALK-positive NSCLCSeven-year follow-up results showed that the median progression-free survival (PFS) in the Lorviqua group remained not reached (NR), while the median PFS in the Xalkori group was 9.1 months. This indicates that more than half of patients treated with Lorviqua maintained treatment benefit without disease progression throughout the follow-up period.At 7 years, progression-free survival rates were 55% in the Lorviqua group versus 3% in the Xalkori group, demonstrating a substantial difference.In particular, for patients who showed no disease progression up to 24 months after receiving Lorviqua, the probability of surviving without disease progression at the 7-year mark was estimated to be 79%.Lorviqua also demonstrated a pronounced benefit in preventing brain metastases. No new cases of intracranial disease progression were reported after 30 months of treatment. The median time to intracranial progression was not reached in the Lorviqua group, compared with 16.4 months in the Xalkori group.Given that ALK-positive NSCLC carries a high risk of brain metastases from early stages and CNS progresses frequently during treatment, durable CNS control is considered highly meaningful in clinical practice.In terms of safety, the adverse event profile remained comparable with the previously reported 5-year follow-up data. Grade 3 or 4 adverse events occurred in 77% of patients receiving Lorviqua and 57% of those receiving Xalkori. However, permanent treatment discontinuation due to treatment-related adverse events (TRAEs) was relatively low at 5% and 6%, respectively. Furthermore, no new treatment-related permanent discontinuations were reported after 26 months in the Lorviqua group.Overall survival (OS), however, has not yet reached the pre-specified analysis threshold, and additional follow-up is ongoing. Accordingly, while these results are significant in that they strengthen the evidence for the potential for long-term disease control, further data will be needed to confirm the ultimate survival benefit.
- Policy
- Govn’t seeks to upgrade 'Overseas AE safety monitoring network’
- by Lee, Jeong-Hwan Jun 01, 2026 09:04am
- The Korean government plans to strengthen Korea’s national and public support policies to resolve frequent drug shortages caused by production or supply discontinuation from poor profitability. At the same time, it intends to modernize the system for collecting overseas safety information on imported medicines through the Korea Orphan & Essential Drug Center (KODC).As the government expands administrative measures that provide essential medicines not supplied or manufactured by domestic private pharmaceutical companies through the KODC, it aims to ensure that information regarding adverse events and side effects associated with overseas medicines can be identified and addressed more rapidly and accurately.On May 31, the Ministry of Food and Drug Safety (MFDS) announced plans to establish a system for collecting safety information and building a database for medicines supplied through the KODC, while also securing a framework for analyzing and reviewing overseas drug safety information.The MFDS will also assess the level of human and material resources required to build and operate a database covering overseas medicines imported through KODC.In Korea, when the supply of a drug manufactured or imported by a private pharmaceutical company is discontinued, or when marketing authorization is withdrawn and no domestic alternative is available, the MFDS uses its emergency import program through the KODC to directly purchase and supply overseas medicines and support patient-specific imports for self-treatment purposes.The Lee Jae-myung administration has been promoting policies to expand emergency-import medicines this year in order to address essential medicine supply disruptions and recurring shortages. As a result, the proportion of medicines supplied through public channels via the KODC is expected to continue to increase.Accordingly, the need to establish a system for collecting, analyzing, and rapidly responding to overseas safety information on medicines distributed by the KODC has become increasingly important.The MFDS will launch a policy research project to establish the scope and methodology for gathering information on medicines supplied through the KODC. The study will examine regulatory approvals, safety information, recalls, and sales suspensions from advanced regulatory agencies such as the US FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).The ministry will also conduct research on creating a database capable of accumulating, managing, and utilizing overseas safety information, while developing a user-friendly system designed to maximize accessibility and practical use.In addition, it plans to establish update cycles, standards, and data display methods to ensure rapid mutual sharing of overseas safety information and real-time incorporation of the latest safety updates.To establish an advisory and review framework for overseas safety information, the MFDS will develop a process for collecting opinions from medical and pharmaceutical experts regarding whether the supply of a medicine should be continued when safety concerns arise.The MFDS intends to define the requirements for expert consultation, develop standardized advisory forms incorporating those requirements, identify appropriate academic societies and organizations to participate, and establish formal consultation procedures.In effect, Korea will be building a physician-pharmacist advisory panel system to enhance domestic responses when overseas drug safety issues emerge.Based on the results of this consultation, a review process will be established to determine whether to continue supply, analyze potential measures such as the emergency introduction of alternative products or suspension of supply.To identify the human and material resources necessary for these new responsibilities, the MFDS will analyze comparable overseas cases and assess its current staffing structure. It will then calculate the appropriate workforce size and personnel costs required for the new tasks and define the roles of individual staff members.An MFDS official explained, “We need a process to collect and build a database of drug safety information originating from overseas regarding medicines supplied and supported by KODC, and to establish measures for gathering expert advice and taking action when issues arise. At the same time, we will identify the human and material resources necessary to carry out these functions.”
- InterView
- "Diagnostics offer an opportunity…'Tevimbra' for gastric cancer"
- by Son, Hyung Min Jun 01, 2026 09:03am
- The treatment landscape for metastatic gastric cancer is rapidly shifting toward a biomarker-driven precision medicine era. While treatment previously centered on cytotoxic chemotherapy, the recent advancements in which therapeutic strategies diverge based on diverse biomarkers, such as HER2, PD-L1, Claudin 18.2, and FGFR, has highlighted the importance of patient-tailored, personalized medicine.With the introduction of immuno-oncology (IO) agents and targeted therapies, the diagnostic process (identifying 'which type of patient' it is, as much as 'which drug to use') has entered a stage where it dictates the success or failure of treatment. As treatment options vary depending on HER2 positivity, PD-L1 expression levels, and Claudin 18.2 expression status, diagnostic accuracy and turnaround time are directly linked to therapeutic opportunities.DailyPharm met with Professor Min-hee Ryu and Professor Jaewon Hyung of the Department of Oncology and Professor Young Soo Park of the Department of Pathology from the Stomach Cancer Multidisciplinary Team at Asan Medical Center to discuss shifting therapeutic strategies driven by the expansion of precision diagnostics in gastric cancer, the clinical implications of Tumor Area Positivity (TAP)-based evaluation, and the evolving immuno-oncology landscape, including 'Tevimbra (tislelizumab)'.The Stomach Cancer Center's Multidisciplinary Team at Asan Medical Center. From left, Professor Min-hee Ryu of the Department of Oncology, Professor Young Soo Park of the Department of Pathology, and Professor Jaewon Hyung of the Department of Oncology As biomarkers expand, the testing and interpretation processes are becoming increasingly complex. In particular, since gastric cancer is recognized as a relatively fast-progressing malignancy, concerns are being raised that a prolonged diagnostic process may delay the optimal initiation timing for first-line therapy.Consequently, the importance of a multidisciplinary approach, in which multiple companion diagnostics (CDx) are performed concurrently at initial staging and the departments of pathology, medical oncology, surgery, and radiology collectively deliberate on the treatment direction, is growing. Asan Medical Center also operates a Stomach Cancer Center Multidisciplinary Team involving multiple clinical specialties, primarily focusing on patients with advanced gastric cancer to formulate optimal therapeutic strategies.In the cancer immunotherapy landscape, PD-L1 evaluation methodology has also become a new point of discussion. While the current domestic reimbursement environment is centered on Combined Positive Score (CPS)-based evaluation, certain recently introduced therapies use a Tumor Area Positivity (TAP)-based approach, raising the possibility that both assessment modalities will coexist in clinical practice for a period. In particular, the TAP-based SP263 assay is attracting attention for its real-world clinical utility and interpretive efficiency, as it is performed on automated platforms that enable a relatively rapid turnaround time.Tevimbra is also a therapeutic agent that uses TAP-based evaluation, and discussions suggest it could serve as a novel alternative for diagnostic efficiency while maintaining continuity with existing CPS-based checkpoint inhibitors. Furthermore, it demonstrated survival benefits in the first-line treatment of HER2-negative metastatic gastric cancer through the RATIONALE 305 study and is included in the US NCCN Guidelines as a recommended first-line treatment option (Category 2A) for patients with HER2-negative, PD-L1-expressing gastric and gastroesophageal junction (GEJ) cancers.In certain patient subgroups with high PD-L1 expression levels (CPS ≥ 5), Tevimbra is recommended as a preferred regimen (Category 1), and its potential is demonstrated in subgroup analyses of patients with peritoneal metastasis, which is also highlighted as a key point of interest.Experts assess that gastric cancer management is moving beyond simply adding new agents and is undergoing a rapid restructuring of the entire diagnosis-to-treatment process. They explain that the expansion of biomarker testing has heightened the clinical significance of pathological interpretation and that multidisciplinary collaboration has become a virtual necessity to avoid missing the critical window for treatment initiation. Q. Why is multidisciplinary care essential in gastric cancer?Professor Min-hee Ryu Professor Ryu: While some gastric cancer patients undergo only surgery or receive only systemic chemotherapy, the majority undergo surgery and chemotherapy either sequentially or concurrently. In the multidisciplinary team, we discuss the sequencing of modalities or, when a diagnosis is challenging, synthesize the opinions of pathology and radiology specialists to establish the diagnostic and therapeutic pathway.Furthermore, there are instances where the presence or absence of metastasis is ambiguous, making it difficult for a single clinical specialty to determine a treatment plan independently. In cases where multiple modalities must be introduced sequentially, discussions are necessary to clarify the treatment order or resolve any diagnostic ambiguity.Professor Park: The significant advantage of multidisciplinary care is that it provides a one-stop solution, rather than forcing patients to navigate multiple departments to gather separate opinions as they did in the past.As the life expectancy of cancer patients extends, we are seeing more patients presenting with multiple malignancies. For example, when a gastric tumor is detected in a patient who had lung cancer five years ago, multiple specialties convene to deliberate on whether to treat it as a primary gastric cancer or evaluate it as a metastasis from the previous malignancy. Consequently, it takes less time to establish a therapeutic strategy compared to the past, and the selected strategies are far more precise.Professor Hyung: Cancer treatment methods are diverse, including chemotherapy, radiation therapy, and surgical resection. In the case of metastatic cancer, systemic chemotherapy is not the sole mandate; instead, various departments collaborate to consider clinical intervention methods, and there are cases where the treatment prognosis improves when an intervention is introduced at the optimal timing. These aspects represent the advantages of the Asan Medical Center's Stomach Cancer Center Multidisciplinary Team.Q. With various therapeutic agents, such as immuno-oncology products and ADCs, recently introduced for gastric cancer, how have treatment goals or patient management approaches shifted following their introduction?Professor Ryu: Recently, as the efficacy of targeted therapies and immunotherapies has been validated in gastric cancer alongside cytotoxic agents, the importance of companion diagnostics to determine patient eligibility has grown substantially. While therapies were previously deployed uniformly without patient stratification, the paradigm has shifted toward screening and selecting patients who are highly likely to derive clinical benefit based on diagnostic readouts, driving improvements in therapeutic outcomes.Professor Hyung: For a long period following the ToGA trial, novel treatment options for gastric cancer remained limited, but the recent introduction of checkpoint inhibitors has dramatically altered the therapeutic landscape. In particular, the implementation of companion diagnostic concepts linked to PD-L1 expression has enabled personalized care, and the efficacy of immuno-oncology combination regimens is being validated. Furthermore, whereas we previously relied on a limited number of assays focused on HER2, we now consider a diverse array of biomarkers concurrently, such as Claudin 18.2, enabling tailored therapy to be far more sophisticated. Durable long-term responses are also being observed in some patients, which I view as a clinically profound shift.Professor Park: It is not that gastric cancer lacks biomarkers; various indicators such as EBV and MMR already existed alongside HER2 and PD-L1, and with the recent addition of novel targets like Claudin 18.2, biomarkers are becoming increasingly segmented. However, in the case of PD-L1, because different antibody clones, such as 22C3, 28-8, and SP263, are paired with distinct therapeutic agents, there is a logistical burden of performing multiple assays concurrently. In this regard, gastric cancer remains a malignancy where immunohistochemistry (IHC)-based testing plays a pivotal role.Q. What are TAP and CPS, and how do these PD-L1 evaluation methodologies differ?Professor Young Soo ParkProfessor Park: TAP is a methodology that determines positivity or negativity based on an area concept rather than a numerical count. Conversely, CPS is a numbers-based evaluation. While both serve as criteria to evaluate PD-L1, their analytical approaches differ.TAP measures the surface area of positively stained cells within the total tumor area, whereas CPS is a calculated ratio based on the raw count of positive cells. To date, the TAP method is generally known to demonstrate slightly higher concordance and reproducibility compared to CPS.In large tertiary hospitals with high daily case volumes, the difference in interpretation time between CPS and TAP may not be substantial, given extensive experience with CPS scoring. However, for pathologists who are initially adopting the workflow or in institutions with lower sample volumes, I believe TAP offers distinct advantages.In particular, because TAP is an area-based measurement, it possesses high potential for integration with AI-driven interpretation or deep learning-based analytics in the current environment, where slide scanning and digital pathology workflows are expanding.Professor Ryu: Because immune-checkpoint inhibitors are linked to companion diagnostics, regulatory approvals and reimbursements are structured around the specific assay methodologies and scoring criteria used for each agent. Currently, Opdivo and Keytruda are reimbursed based on the CPS criteria used in their registrational trials. At the same time, Tevimbra was developed using TAP, requiring ongoing discussions about how its reimbursement criteria will be established. In South Korea, HIRA tends to enforce criteria identical to those used in regulatory approval trials; therefore, it is highly likely that clinicians will continue to use the exact testing methodology aligned with each therapeutic agent. It appears that the two evaluation systems will co-exist for a certain period, aligned to their corresponding drugs.Professor Hyung: While there is a global trend toward a more flexible application by acknowledging a degree of interchangeability between diverse assays, South Korea maintains relatively stringent companion diagnostic standards, meaning that the diversity of testing modalities will likely be directly reflected in clinical practice. Ultimately, in real-world settings, an approach that synthesizes the patient's performance status and biomarker profiles to select the therapeutic option that best matches each metric will become critical.Q. What shifts do you anticipate new evaluation methodologies like TAP will bring to therapeutic strategies, clinical decision-making, and the future trajectory of PD-L1 assessment?Professor Park: Rather than an entirely unprecedented concept, TAP extends existing PD-L1 evaluation methodologies, such as CPS. However, its area-based approach makes it more intuitive and accessible. Due to the structure in South Korea, in which the exact assays and scoring criteria from pivotal trials are strictly applied, selective CPS and TAP utilization depending on the therapeutic agent will persist.Another critical aspect is the operational difference between the assays. The SP263 clone used for TAP is deployed on fully automated instrumentation enabling same-day staining. In contrast, the 22C3 or 28-8 pharmDx assays utilized for CPS rely on semi-automated platforms that can be more time-consuming or necessitate send-out testing to external reference labs. Taking these factors into account, the adoption of TAP should be viewed not as a matter of absolute superiority, but as a choice reflecting real-world clinical utility and accessibility.Professor Ryu: In clinical oncology, therapeutic decisions are based on pathology reports, making interpretive consistency and reproducibility paramount. Data to date suggest that TAP and CPS exhibit a substantial correlation. I believe both modalities are viable. However, when considering workflow convenience, staining intensity, crispness, and adaptability for digital pathology or AI-driven scoring, TAP may offer a slight competitive edge. In particular, SP263-based TAP is known to yield relatively distinct staining, which holds promise for practical clinical implementation.Professor Hyung: Because manual single-cell counting is highly labor-intensive, rapid and consistent interpretation will become increasingly critical moving forward. In that respect, the TAP method offers distinct advantages. Furthermore, given the growing trend toward digital pathology and AI-driven analytics, the area-based approach is technically easier to integrate, underscoring its strong future utility.Q. Multiple immune-checkpoint inhibitors have recently been introduced into the metastatic gastric cancer treatment landscape. In what ways do you think Tevimbra, as a later entrant to the market, distinguished from existing therapeutic options?Professor Jaewon Hyung Professor Hyung: Although Tevimbra has entered real-world clinical use, our institutional experience remains early, and without head-to-head comparative data, any definitive conclusions must be drawn cautiously. However, since a statistically significant improvement in overall survival (OS) was reported in its clinical trials and major guidelines like the NCCN recommend it on par with other checkpoint inhibitors, it is highly likely to deliver a comparable level of therapeutic efficacy.Notably, in gastric cancer, numerous observational data indicate that the efficacy of checkpoint inhibitors is relatively diminished in patients presenting with concurrent peritoneal metastasis and malignant ascites. There is anticipation that Tevimbra could serve as a valuable therapeutic agent, demonstrating added potential to address this specific area of high unmet medical need.Professor Ryu: Another frequently discussed aspect regarding Tevimbra is the peritoneal metastasis cohort. Historical data for conventional immune checkpoint inhibitors have indicated relatively limited efficacy in patients with peritoneal disease; conversely, subset analyses of Tevimbra have suggested signal activity and efficacy even in this cohort. Granted, variations in sample size exist, and whether these subgroup data can be directly generalized remains a separate issue. Nevertheless, demonstrating a potential therapeutic signal in peritoneal metastasis, setting it apart from legacy checkpoint inhibitors, is clinically noteworthy.Q. What are your perspectives on the current reimbursement criteria for immune-checkpoint inhibitors and the necessity of securing reimbursement for Tevimbra moving forward?Professor Ryu: From a clinician's perspective, expanding the therapeutic arsenal is inherently beneficial for patients. Furthermore, I believe institutional equity is crucial in this domain. While immune-checkpoint inhibitors generally share a similar mechanism of action, Tevimbra is characterized by its demonstrated potential for efficacy even in patients with peritoneal metastasis, as previously discussed. Therefore, Tevimbra must be integrated into the system as a therapeutic option on par with Opdivo or Keytruda. If one agent is reimbursed while another remains non-reimbursed, real-world clinical prescribing will inevitably lean heavily toward the insurance-covered medication.Professor Hyung: Diversifying therapeutic options yields clear advantages for both patients and treating physicians. Particularly in gastric cancer, the prevalence of peritoneal metastasis is substantial, and patients with metastasis have a poor prognosis. Consequently, if a treatment offers even a slight therapeutic advantage in this patient group, it would be highly beneficial in real-world clinical practice.
