Dr. Powles on FDA Approval of Pembrolizumab Plus Axitinib in Advanced RCC

Thomas Powles, MBBS, MRCP, MD, director, Barts Cancer Institute, discusses the FDA approval of the combination of pembrolizumab (Keytruda) plus axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma (RCC).

The approval is based on phase III data from the KEYNOTE-426 trial, which demonstrated that the TKI/checkpoint inhibitor combination significantly improved overall survival (OS) and progression-free survival (PFS) compared with sunitinib (Sutent). The combination resulted in a 47% reduction in the risk of death compared with the former standard of care. Moreover, median PFS was 15.1 months with the combination compared with 11.1 months with VEGF TKI monotherapy. Median OS was not reached in either arm, but 18-month OS rates were observed to be significantly higher with pembrolizumab plus axitinib.

This approval is a huge step forward for this patient population for several reasons, Powles says. One needs to only look back to 2005, when the median OS for patients with advanced RCC was approximately 1 year, with no effective therapies available. With the introduction of VEGF TKIs, survival doubled in these patients, but the benefit seen with this combination is unheard of in the RCC space. This approval offers an opportunity for patients to receive aggressive therapy in the frontline setting with outstanding PFS and OS benefit as well as good tolerability.