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BeiGene Provides Update on FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA?, for Treatment of ESCC and Gastric/GEJ Cancers

Business Wire
16 min read

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Vote recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors in advanced esophageal squamous cell carcinoma and gastric/gastroesophageal junction cancers

Biologics License Applications for TEVIMBRA in these indications are under review with the FDA

SAN MATEO, Calif., September 26, 2024--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA? (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%.

The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 (G/GEJ) and RATIONALE-306 (ESCC) studies, as well as other pivotal studies from the two other PD-1 inhibitors approved in these indications. The Advisory Committee voted 10 to 2, with one abstaining, that the risk benefit assessment was not favorable for the use of PD-1 inhibitors in G/GEJ with PD-L1 expression less than 1%. The ODAC members voted 11 to 1, with one abstaining, that the risk benefit profile was not favorable for ESCC patients with a PD-L1 expression less than 1%. The vote represents a recommended class-wide PD-L1 expression level cut-off across PD-1 inhibitors reviewed during the meeting for these patient populations.

"The survival rates for gastric and esophageal cancer remain strikingly low for the majority of patients who are diagnosed with late-stage disease and there is a need for additional treatments that can extend life," said Sally Werner, RN, BSN, MSHA, CEO at Cancer Support Community. "We appreciate the FDA's recognition of the need for safe and effective treatments for these cancers. Additional treatment options offer physicians and their patients choices on the treatment that is right for them."

"The vote by ODAC members to recommend a class-level cut-off of PD-L1 expression for PD-1 inhibitors used in the treatment of gastric/GEJ cancers and ESCC will help to establish a standard for clinicians and the patients they treat," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to working with the FDA as it completes its review of our BLAs for TEVIMBRA, and we strive to bring this therapy to applicable patients in the U.S."

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