FDA Grants Priority Review to Avelumab Combo to Treat Advanced RCC

The FDA granted a priority review to avelumab (Bavencio) in combination with axitinib (Inlyta) 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 III JAVELIN Renal 101 trial, designed to compare the combination with sunitinib (Sutent) in 886 patients with advanced RCC.

Patients were randomized to receive either 10 mg/kg of avelumab intravenously every 2 weeks in combination with 5 mg of axitinib orally twice daily (n = 442) or 50 mg of sunitinib orally once a day on a schedule of 4 weeks on followed by 2 weeks off (n = 444).

The primary endpoints were progression-free survival (PFS) in patients testing positive for PD-L1 expression, and overall survival (OS) in PD-L1—positive patients up to 5 years.

Among those with PD-L1—positive tumors, the combination arm demonstrated superior PFS compared with those who received sunitinib (13.8 vs 7.2 months, respectively; hazard ratio [HR] = 0.61; P < .0001). Similarly, median PFS was 13.8 vs 8.4 months (HR = 0.69; P = .0001), respectively, regardless of PD-L1 expression. In addition, confirmed objective response rates were 55.2% in the combination arm (95% CI, 49.9—61.2) and 25.5% in the sunitinib arm (95% CI, 20.6–30.9).

In total, 71.2% of the combination arm and 71.5% in the sunitinib arm experienced treatment-emergent adverse events (TEAEs) that were grade 3 or higher, which led to treatment discontinuation in 22.8% and 13.4%, 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.