The approval was based on data from the phase III Javelin Renal 101 study, in which the combination significantly improved median progression-free survival (PFS) compared against sunitinib by more than five months in the intent-to-treat (ITT) patient population.
Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody, and has been demonstrated in preclinical models to engage both the adaptive and innate immune functions.
Javelin, the clinical development program for avelumab, included around 30 clinical programs with about 10,000 patients evaluated across more than 15 different tumor types.
Merck KGaA innovative medicine franchises global head and EMD Serono president Rehan Verjee said: “With today’s FDA approval of BAVENCIO in combination with INLYTA, we feel privileged that we can offer patients with first-line advanced renal cell carcinoma a new treatment option.”
According to Pfizer, the European Medicines Agency (EMA) validated the Type II variation application for Bavencio in combination with Inlyta in advanced RCC in March this year, while a supplemental application for Bavencio in combination with Inlyta in unresectable or metastatic RCC was submitted in Japan in January this year.
Javelin Renal 101 trial is a randomized, multicenter and open-label study of Bavencio in combination with Inlyta in 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression.
The trail’s major efficacy outcome were PFS as evaluated by a Blinded Independent Central Review (BICR) using RECIST v1.1 and OS in patients with PD-L1-positive tumors using a clinical trial assay.
In November 2014, Merck and Pfizer have collaborated to co-develop and co-commercialize Bavencio.
Pfizer Oncology global president Andy Schmeltz said: “Today’s approval of BAVENCIO in combination with INLYTA builds on Pfizer’s long heritage in bringing innovation to the RCC community with the hopes of making a significant and meaningful impact on the lives of patients.
“For more than 12 years, Pfizer has led the field in its commitment to developing new treatments for patients with advanced kidney cancer.”