K-made Leclaza monotherapy to be showcased at global meeting

Leclaza monotherapy demonstrates clinical benefit compared to Tagrisso

Rivoceranib, a targeted anti-cancer agent, shows effect in perioperative adjuvant therapy in NSCLC patients

Korean biopharmaceutical companies continue to gain R&D achievements for targeted anti-cancer drugs.

 

Companies have prepared to present their Korean-made anti-cancer drugs, including Leclaza and Rivoceranib at the 2024 World Conference on Lung Cancer, which will be held September 7-10 in San Diego, USA.

 

Yuhan Pharmaceutical will present the clinical results comparing the efficacy of its proprietary Leclaza monotherapy, a non-small cell lung cancer (NSCLC) treatment, to Tagrisso.

 

This month, Leclaza plus Rybrevant combination therapy passed the U.S.

 

Food and Drug Administration (FDA) approval.

 

A shift in the market for the first-line treatment of EGFR-positive NSCLC is expected if Leclaza monotherapy obtains better clinical results than Tagrisso monotherapy.

 

HLB group and Jiangsu Hengrui Pharmaceuticals will present the clinical results of their targeted anti-cancer drug, Rivoceranib.

 

The companies attempted to win FDA approval for Rivoceranib in combination with camrelizumab, a PD-1 immune checkpoint inhibitor.

 

However, they received a complete response letter (CRL) request in May.

 

HLB group will retry for approval by demonstrating effectiveness in various solid cancers, including liver cancer.

 

Will present a follow-up study for the MARIPOSA trial, comparing Leclaza vs.

 

Tagrisso monotherapies

Treatments for NSCLC.

According to industry sources on August 27th, the results of the study comparing the efficacy and safety profile of Leclaza monotherapy and Tagrisso monotherapy will be presented at WCLC 2024, to be held on September 4th.

 

Leclaza and Tagrisso are treatments for targeting NSCLC harboring mutations of EGFR in exon 19 and exon 21 (L858R).

 

Based on the Phase 3 MARIPOSA study results, disclosed last year, Leclaza plus Rybrevant combination therapy showed improvement in progression-free survival (PFS) compared to Tagrisso monotherapy.

 

The study included patient treated with Leclaza monotherapy as a reference group.

 

The results showed that the PFS for the Leclaza monotherapy group was 18.5 months, longer than 16.6 months for the Tagrisso monotherapy group.

 

The company will present secondary results for the MARIPOSA study during the upcoming conference.

 

The study is the first investigative analysis evaluating two third-generation EGFR-TKIs using randomization and a double-blind method.

 

The study focused on 216 patients treated with Leclaza and 429 patients treated with Tagrisso.

 

The primary endpoints included a blinded independent central view (BICR) PFS, duration of response (DOR), overall survival (OS), and safety.

 

According to the disclosed abstract, BICR ORR for the Leclaza group was 88%, and for the Tagrisso group, it was 85%.

 

However, the secondary analysis showed that Leclaza provided more clinical benefits than Tagrisso monotherapy in patients with biomarkers of high-risk disease, including TP53, circulating tumor DNA (ctDNA), and brain metastasis.

 

In most solid cancers, patients with brain metastasis, TP53 mutations, and ctDNA detection tend to show poor prognosis.

 

The median PFS for patients with a history of brain metastasis was 16.4 months for Leclaza, whereas Tagrisso's was 13.0 months.

 

Among patients with detectable ctDNA, the median PFS for the Leclaza group was 18.4 months, and for the Tagrisso group, it was 14.8 months.

 

Among patients with TP53 mutations, the Leclaza group had a median PFS of 14.6 months, which was longer than 12.9 months for the Tagrisso group.

 

Two treatments had similar safety profiles, with moderate side effects between Grade 1 and Grade 2.

 

Tagrisso group was more likely to have adverse reactions like diarrhea, thrombocytopenia, and reduced white blood cells.

 

The Leclaza group was more likely to have rashes and paresthesia.

 

The research team evaluated that "The efficacy and safety were comparable between Leclaza and Tagrisso.

 

The results indicate that Leclaza can be a new treatment option for patients with EGFR-mutated advanced NSCLC and high-risk patients." Rivoceranib plus camrelizumab seen as a potential treatment for early lung cancer

On September 8th, clinical trial results of the combination of the HLB group's Rivoceranib and Jiangsu Hengrui Pharmaceuticals' camrelizumab as perioperative neoadjuvant therapy.

 

HLB group and Jiangsu Hengrui Pharmaceuticals, the developers of these two treatments, are evaluating the clinical efficacy of the combination of Rivoceranib, a vascular endothelial growth factor receptor-2 (VEGFR2) inhibitor, and camrelizumab, an immune checkpoint inhibitor.

 

The current Phase 2 clinical trial evaluated the effectiveness and safety of Rivoceranib plus camrelizumab plus chemotherapy in patients with Stage 3 NSCLC.

 

The patients received surgery after the combination therapy.

 

The primary endpoint was the major pathological response (MPR) rate.

 

The secondary endpoint included pathological complete response (pCR) rate, ORR, and safety.

 

Based on the disclosed abstract, the combination of Rivoceranib plus camrelizumab plus chemotherapy as perioperative adjuvant therapy increased the rate of success for lung cancer surgery.

 

The clinical results involving 29 patients showed that 19 patients had complete cancer removal.

 

The combination therapy demonstrated 86.2% ORR, the percentage of patients with a confirmed objective response.

 

The most common adverse reactions were white blood cell reduction (31.0%), thrombocytopenia (17.2%), rash (17.2%), and fatigue (13.8%).

 

OS has not been reported due to incompleteness.

 

The research group said, "The combination of Rivoceranib plus camrelizumab plus chemotherapy showed clinically meaningful anti-tumor activation and manageable safety without blood toxicity," and added, "It seems to be a potential treatment option for patients with resectable Stage 3 NSCLC." HLB group and Jiangsu Hengrui Pharmaceuticals plan to investigate potential in various fields, including liver cancer, gastric cancer, adrenocortical carcinoma, colorectal cancer, ovarian cancer, bile duct cancer, and esophagus cancer, in addition to early NSCLC.