Transcenta Presents Promising Phase II Results for Osemitamab Triple Combo in G/GEJ Cancer at ASCO 2024

A recent announcement from Transcenta Holding Limited unveiled encouraging results from their Phase I/IIa Cohort-G study on the trial drug Osemitamab (TST001) in combination with Nivolumab and CAPOX as a first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) cancer. Conducted across their global facilities, the study showcased significant efficacy, particularly in patients with high or medium (H/M) expression of the CLDN18.2 biomarker.

Key findings from the study indicated a median progression-free survival (mPFS) of 12.6 months in patients with H/M levels of CLDN18.2 expression, irrespective of their PD-L1 CPS values. This includes patients with PD-L1 CPS<5, who represented approximately 80% of the CLDN18.2 positive cohort. The study enrolled patients regardless of their CLDN18.2 or PD-L1 CPS levels, providing robust data on the triple combination therapy's effectiveness.

For comparison, patients with low or no CLDN18.2 expression served as a control group, revealing a hazard ratio (HR) of 0.443 in favor of the H/M expressors. These patients also showed a confirmed overall response rate of 68%. Historical data indicate that similar treatments, such as Zolbetuximab combined with CAPOX, improve PFS to an extent, but Nivolumab with chemotherapy for patients with PD-L1 CPS<5 shows minimal benefit. This new triple combination therapy, however, demonstrates markedly superior results.

The study data will be presented at the ASCO 2024 Annual Meeting, highlighting the significance of these findings. Dr. Caroline Germa, Executive Vice President at Transcenta, emphasized that these results validate the company's strategy for a Global Phase III trial. The trial aims to establish Osemitamab as a global therapy for HER2-negative metastatic gastric or G/GEJ adenocarcinoma, potentially elevating the current standard of care.

Professor Lin Shen, the study's Principal Investigator, expressed optimism about the impact of these results on first-line treatment efficacy and progression-free survival (PFS) for patients. The safety profile of the combination therapy was consistent with previous data, showing manageable side effects primarily involving nausea, hypoalbuminemia, and vomiting, most of which were low grade.

Osemitamab (TST001) is a high-affinity humanized monoclonal antibody targeting CLDN18.2, developed using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. This technology enhances the drug's antibody-dependent cellular cytotoxicity (ADCC) activity by significantly reducing its fucose content. Clinical trials are currently ongoing in the U.S. and China, and the drug has received Orphan Drug Designation from the FDA for treating gastric, gastroesophageal junction, and pancreatic cancers.

Transcenta, listed on HKEX, is a clinical-stage biopharmaceutical company specializing in the discovery, research, development, and manufacturing of antibody-based therapeutics. The company operates globally, with key research and development centers in Suzhou, Hangzhou, Princeton, and several locations in China. Transcenta is currently developing 13 therapeutic antibody molecules targeting oncology and select non-oncology conditions.

This breakthrough marks a significant step in advancing treatment options for patients with advanced G/GEJ cancer, giving hope for improved survival rates and quality of life. The medical community eagerly anticipates further details and future developments from Transcenta’s ongoing trials.

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