FDA Grants Priority Review to Bavencio Plus Inlyta to Treat Advanced Renal Cell Carcinoma

The Food and Drug Administration (FDA) granted a priority review to the combination use of Bavencio (avelumab) plus Inlyta (axitinib) to treat patients with advanced renal cell carcinoma (RCC), according to Pfizer.

“The combination of Bavencio with Inlyta builds on Pfizer’s significant heritage in advancing standards of care for patients with advanced RCC and has the potential to make a meaningful impact for the lives of patients,” Chris Boshoff, M.D., Ph.D., chief development officer of oncology at Pfizer Global Product Development, said in a press release. “We look forward to working with the FDA to bring this potential new treatment option to patients as quickly as possible.”

The supplemental biologics license application was based on data from the pivotal phase 3 JAVELIN Renal 101 trial, designed to compare the combination with Sutent (sunitinib) in 886 patients with advanced RCC.

Patients were randomized to receive either 10 mg/kg of Bavencio intravenously every two weeks in combination with 5 mg of Inlyta orally twice daily (442 patients) or 50 mg of Sutent orally once a day on a schedule of four weeks on followed by two weeks off (444 patients).

The primary endpoints were progression-free survival, or the time to disease worsening, in patients testing positive for PD-L1 expression, and overall survival in PD-L1—positive patients up to five years.

Among those with PD-L1—positive tumors, the combination arm demonstrated superior progression-free survival compared with those who received Sutent (13.8 vs 7.2 months, respectively). Similarly, median progression-free survival was 13.8 vs 8.4 months, respectively, regardless of PD-L1 expression. In addition, confirmed objective response rates were 55.2 percent in the combination arm and 25.5 percent in the Sutent arm.

In total, 71.2 percent of the combination arm and 71.5 percent in the Sutent arm experienced treatment-emergent side effects that were grade 3 or higher, which led to treatment discontinuation in 22.8 percent and 13.4 percent, respectively.

"Our alliance is focused on the development of potential new treatment options for patients with cancers that have high unmet medical needs, including the broad spectrum of people living with advanced RCC," Luciano Rossetti, M.D., executive vice president and head of global research and development at the Biopharma business of Merck KGaA in Darmstadt, Germany, said in the release.

The FDA set a target action date for June 2019.