BeiGene says FDA’s ODAC sees favorable benefit-risk profile of PD-1 inhibitors

BeiGene announced the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA, for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma expressing PD-L1 and gastric/gastroesophageal junction cancers expressing PD-L1 greater than1%. The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 and RATIONALE-306 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.”