FDA Approves Bavencio-Inlyta Combo for Advanced Renal Cell Carcinoma

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

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

"A kidney cancer diagnosis is life-changing for both patients and their loved ones and having a treatment strategy for their disease quickly becomes a priority," Dena Battle, president of KCCure, said in a press release. "The approval of new treatments such as Bavencio in combination with Inlyta gives patients with advanced RCC much-needed options."

The agency based its approval on positive results from the randomized, multicenter, open-label phase 3 JAVELIN Renal 101 study — designed to evaluate Bavencio in combination with Inlyta compared with Sutent (sunitinib) in 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression.

The combination significantly improved median progression-free survival — or the time from treatment to disease worsening – by more than five months compared with Sutent (13.8 months vs. 8.4 months, respectively).

In addition, the objective response rate was doubled with the combination compared with Sutent (51.4% vs. 25.7%, respectively).

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

The most common side effects included diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Serious side effects occurred in 35% of patients receiving the combination. In addition, the incidence of major cardiovascular side effects was higher with the combination compared with Sutent.

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

"As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients," Dr. Robert J. Motzer, Jack and Dorothy Byrne Chair in Clinical Oncology at Memorial Sloan Kettering Cancer Center and principal investigator, said in the release.

"With today's FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib,” he added.