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FDA Sets Review Date for Tislelizumab in Stomach Cancer


The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.

The FDA has accepted BeiGene’s biologics license application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, to treat patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024.

American Cancer Society estimates that this year there will about 26,890 new cases of stomach cancer and about 10,880 deaths.

Tevimbra is humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

The filing is based on results from the global RATIONALE-305 trial, which met its primary endpoint of overall survival of 15.0 months for patients treated with Tevimbra in combination with investigator’s choice of chemotherapy compared with 12.9 months for patients treated with placebo plus chemotherapy. Tevimbra demonstrated a 20% reduction in the risk of death.

Additionally, Tevimbra plus chemotherapy was associated with a higher objective response rate (47.3% vs. 40.5%) and median duration of response (8.6 months vs. 7.2 months) compared with placebo plus chemotherapy. Median progression-free survival for the Tevimbra patients was 6.9 months vs. 6.2 months for placebo.

Grade ≥3 treatment-related adverse events (TRAEs) occurred in 53.8% of patients in the Tevimbra arm and 49.8% of patients in the placebo arm. The most common treatment-related adverse events of any grade with an incidence ≥30% were nausea, decreased appetite, platelet count decreased, neutrophil count decreased, vomiting, and anemia.

Data were presented at the European Society for Medical Oncology (ESMO) Congress 2023.

Tevimbra is also under review a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma after chemotherapy. It is also being studied in a phase 3 trial to treat patients with non-small-cell lung cancer.

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