FDA Approves First-Line Avelumab Plus Axitinib for Advanced RCC

The FDA approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), according to EMD Serono — the drug’s manufacturer.

This is the first FDA approval of an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

"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," Andy Schmeltz, global president of Pfizer Oncology said in a press release. "For more than 12 years, Pfizer has led the field in its commitment to developing new treatments for patients with advanced kidney cancer."

The agency based its approval on positive results from the randomized, multicenter, open-label phase III JAVELIN Renal 101 study — designed to evaluate avelumab plus axitinib compared with sunitinib (Sutent) in 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression.

The combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than 5 months in the intent-to-treat (ITT) patient population (HR, 0.69; 95% CI, 0.56—0.84; P = .0002). Median PFS for the combination was 13.8 months (95% CI, 11.1-NE), compared with 8.4 months with sunitinib (95% CI, 6.9-11.1).

the objective response rate (ORR) with the combination was doubled in the ITT population versus sunitinib [51.4% (95% CI, 46.6-56.1) vs. 25.7% (95% CI, 21.7-30.0)].

With a median overall survival (OS) follow-up of 19 months, data were immature, with 27% of deaths in the ITT population. The trial is continuing as planned, according to the release.

The most common adverse events (AEs) were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Serious AEs occurred in 35% of patients in the combination arm. The incidence of major cardiovascular AEs was higher with the combination compared with sunitinib.

Findings from the study have been published in The New England Journal of Medicine.

"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," Rehan Verjee, president of EMD Serono, and global head of innovative medicine franchises at Merck KGaA, said in the release.