The US Food and Drug Administration (FDA) has granted Transcenta clearance to proceed with the Phase III trial of osemitamab for the treatment of HER2-negative, CLDN18.2 expressing locally advanced, metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.

Osemitamab is a CLDN18.2 expressing monoclonal antibody being developed for the treatment of cancers due to clinical evidence that it has anti-tumour properties. The drug gained approval from the Centre for Drug Evaluation (CDE) in China and MFDS in South Korea for the Phase III trial in July 2023.

Current drugs used to treat metastatic gastric cancer include nivolumab, marketed as Opdivo by Bristol-Myers Squibb. Opdivo made $8.2bn last year, according to Bristol-Myers Squibb 2022 annual report. Treatment outcomes have improved with the use of nivolumab, but the median survival time with chemotherapy is 14 months.

The TranStar 301 global Phase III trial (GDCT0476185) will observe osemitamab in combination with nivolumab and chemotherapy.

Executive vice president Global Medicine Development and chief medical officer of Transcenta Caroline Germa said: “The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. Securing FDA endorsement on critical program elements represents a pivotal milestone in advancing our Phase III trial in the US.”

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