BLA application for Tevimbra (tislelizumab) for first-line gastric or gastroesophageal junction cancers accepted by FDA – BeiGene

BeiGene, Ltd. announced that the FDA has accepted a Biologics License Application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of 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.

“There is an urgent need for new treatment options for gastric cancer, which is often diagnosed at the advanced or metastatic stage,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “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.”

The filing is based on results from the global RATIONALE-305 trial. The study 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 to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), demonstrating 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 to placebo plus chemotherapy. Median progression-free survival for Tevimbra plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]). The safety profile for Tevimbra in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.

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

Tevimbra was recently approved by the European Commission for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. The FDA is also reviewing a BLA for Tevimbra as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC with a target action date in July 2024. A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.