Transcenta Announces Promising Results in Clinical Trial for Osemitamab
On May 28, Transcenta revealed encouraging outcomes from its Phase I/IIa trial of Osemitamab (TST001) combined with Nivolumab and CAPOX for addressing HER2-negative metastatic gastric or gastroesophageal adenocarcinoma. The triple combination therapy demonstrated a median progression-free survival (PFS) of 12.6 months for patients with high or medium CLDN18.2 expression, surpassing previous doublet combinations. These results will be presented at the ASCO 2024 annual meeting. This achievement bolsters the company's global Phase III trial, which secured FDA clearance in October 2023, and underscores the potential of immunotherapies within the G/GEJ cancer market.
Key Takeaways
- The Phase I/IIa trial by Transcenta highlighted the improvement in progression-free survival (PFS) for patients with HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma when treated with Osemitamab (TST001) in conjunction with Nivolumab and CAPOX.
- Patients with high or medium CLDN18.2 expression experienced a median PFS of 12.6 months, while those with low expression had 8.5 months, and the rest had 6.7 months.
- The safety profile of the triple combination therapy aligns with the previously evaluated osemitamab and CAPOX combination, with mainly grade 1 or 2 toxicities.
- Transcenta is scheduled to present the findings at the American Society of Clinical Oncology (ASCO) 2024 annual meeting in Chicago, US.
- The G/GEJ cancer market is poised to reach $4.72 billion by 2029, driven by the sales of Opdivo and Keytruda in the first-line metastatic setting.
Analysis
The encouraging trial results of Osemitamab (TST001) in treating HER2-negative metastatic gastric or gastroesophageal adenocarcinoma by Transcenta could potentially disrupt the G/GEJ cancer market, dominated by Opdivo and Keytruda. This development might particularly impact biopharma companies specializing in oncology treatments and investors with stakes in this sector. The enhanced progression-free survival rates signify the potential of immunotherapies, potentially leading to further breakthroughs in the field. However, it is essential to monitor potential long-term side effects and the cost-effectiveness of this therapy. Overall, this advancement underscores Transcenta's expanding presence in the global oncology market, with possible ramifications for competitors and collaborators.
Did You Know?
- Osemitamab (TST001): A monoclonal antibody developed by Transcenta, designed to target Claudin18.2 (CLDN18.2), a protein overexpressed in various cancers, including gastric and gastroesophageal adenocarcinoma. Osemitamab is an investigational drug and has not yet been approved by regulatory authorities.
- Nivolumab: A type of immunotherapy drug called a programmed cell death protein 1 (PD-1) inhibitor, marketed under the brand name Opdivo by Bristol Myers Squibb. Nivolumab works by blocking the PD-1 protein, which helps keep cancer cells hidden from the immune system, thus allowing the immune system to identify and destroy cancer cells more effectively.
- CAPOX: A chemotherapy regimen that combines the drugs capecitabine and oxaliplatin. CAPOX is often used to treat advanced or metastatic gastric and gastroesophageal cancers.
- HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma: A specific type of advanced or metastatic cancer that has spread beyond the stomach or gastroesophageal junction and does not overexpress the human epidermal growth factor receptor 2 (HER2) protein. HER2-negative cancers require alternative treatment approaches.
- Progression-free survival (PFS): A measure of how long a patient lives without their disease worsening or progressing after beginning treatment.
- G/GEJ cancer market: The market for treatments and drugs specifically targeting gastric and gastroesophageal cancers, projected to reach $4.72 billion by 2029, largely driven by Opdivo and Keytruda sales.