Pfizer, EMD Serono announce publication of Phase 3 data for BAVENCIO plus INLYTA
Merck KGaA, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, and Pfizer announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine. The combination of BAVENCIO and INLYTA significantly extended median progression-free survival by more than 5 months compared with SUTENT as a first-line treatment for patients with advanced renal cell carcinoma, irrespective of PD-L1 expression. Further, the objective response rate was doubled with BAVENCIO+INLYTA versus SUTENT in this population. The study is continuing for the other primary endpoint of overall survival. Additional data presented at the 2019 Genitourinary Cancers Symposium reinforce the consistency of the PFS and ORR results across patient subgroups, including patients with favorable, intermediate and poor prognoses as well as those with PD-L1-positive or negative tumors. In subgroup analyses, approximately two-thirds of patients with favorable risk achieved a complete or partial response with BAVENCIO+INLYTA. Median PFS for these patients is not yet estimable. BAVENCIO+INLYTA also extended median PFS2, defined as the time from randomization to disease progression on next-line therapy and increased median duration of response by more than four months in the overall population. Adverse events of grade 3 or higher during treatment occurred in 71.2% of patients in the BAVENCIO+INLYTA arm and 71.5% in the SUTENT arm. In the combination arm, 9.0% of patients experienced grade 3 or higher immune-related adverse events. Grade 5 events occurred in three patients in the BAVENCIO+INLYTA arm and in one patient in the SUTENT arm. There were fewer discontinuations due to adverse events that occurred during treatment with BAVENCIO+INLYTA, compared with SUTENT. On February 11, 2019, the alliance announced that the U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for BAVENCIO in combination with INLYTA for patients with advanced RCC. The application has been given a target action date in June 2019. A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019. In December 2017, the FDA granted Breakthrough Therapy Designation for BAVENCIO in combination with INLYTA for treatment-naive patients with advanced RCC. Despite available therapies, the outlook for patients with advanced RCC remains poor.