FDA to Review Tevimbra Plus Chemo in Gastric Cancers

The FDA will review Tevimbra plus chemotherapy for patients with certain types of gastric cancers.

The Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Tevimbra (tislelizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, with the agency’s action date on the application expected in December of 2024, according to a news release from the drug’s manufacturerm BeiGene.

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The application was based on the findings of the RATIONALE-305 trial, which demonstrated an average overall survival (OS, the time a patient lives following treatment regardless of disease status) of 15 months for treatment with Tevimbra plus chemotherapy, compared with an OS of 12.9 months for patients treated with chemotherapy plus a placebo, according to BeiGene.

Tevimbra, BeiGene explained, is an immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody designed to help the body’s immune system detect and attack tumors.

There will be approximately 26,890 new cases of stomach cancer, and 10,880 deaths from stomach cancer, also known as gastric cancer, in 2024, the American Cancer Society estimated. Gastroesophageal junction adenocarcinoma, the National Cancer Institute explained, is a type of stomach cancer that is formed where the esophagus meets the gastric cardia area of the stomach. Stomach cancer has a five-year survival rate of 36%, according to the National Cancer Institute.

“There is an urgent need for new treatment options for gastric cancer, which is often diagnosed at the advanced or metastatic stage,” said Dr. Mark Lanasa, chief medical officer, solid tumors, at BeiGene, in the news release. “In clinical trials, Tevimbra has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer. This FDA acceptance brings us one step closer to delivering on a new treatment option for patients who often face poor prognoses.”

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In addition to demonstrating a 20% reduced risk of death, in RATIONALE-305 Tevimbra plus chemotherapy had an objective response rate (percentage of patients who either partially or completely responded to treatment) of 47.3% versus 40.5% among patients treated with placebo and chemotherapy as well as median durations of response of 8.6 months and 7.2 months and median progression-free survival (the time a patient lives without their disease spreading or worsening) of 6.9 months versus 6.2 months, respectively, according to BeiGene.

Grade 3 or higher treatment-related side effects occurred in 53.8% of RATIONALE-305 participants treated with Tevimbra and chemotherapy and 49.8% of patients treated with placebo plus chemotherapy, BeiGene stated, noting that the most common side effects of any grade with an incidence of at least 30% were nausea, decreased appetite, platelet count decreased, decreased count of neutrophils (a type of white blood cell), vomiting and anemia (low red blood cells).

The manufacturer noted that Tevimbra is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) with a target action date of July 2024, and that a BLA is under review by the agency for the treatment of patients with advanced or metastatic ESCC after chemotherapy.

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