Pfizer & Merck's Inlyta combo becomes first FDA-approved anti-PD-L1 therapy for kidney cancer

The FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (RCC). The decision was announced by the drug’s co-developers Merck KGaA and Pfizer, and marks the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen in this indication.

Around 20-30% of new diagnoses in RCC are made at an advanced stage, and almost a tired of early-stage diagnoses go on to develop metastases, meaning there is a considerable unmet need for first-line treatment which safely delay progression of the disease.

Phase 3 data submitted in support of the drug application illustrated that use of the drug combo extended median progression-free survival (PFS) by over five months in the intent-to-treat (ITT) population compared to Pfizer’s Sutent (sunitinib). Additionally, the combo doubled objective response rate (ORR) to 51.4% from 25.6% with Sutent. At the time of analysis, overall survival (OS) data was immature, so the two companies confirmed that the trial will proceed as planned and this data will be collected.

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

Matt Fellows