Dr. McGregor on Implications of the FDA Approval of Pembrolizumab/Axitinib in RCC

Bradley McGregor, MD, clinical director, Lank Center for Genitourinary Oncology, senior physician, Dana-Farber Cancer Institute, and instructor of medicine, Harvard Medical School, discusses the clinical implications of the FDA approval of pembrolizumab (Keytruda) and axitinib (Inlyta) in advanced renal cell carcinoma (RCC).

The FDA approval of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of patients with poor- and intermediate-risk advanced RCC was the first regimen to be approved according to risk status, says McGregor. In terms of newer combination regimens such as pembrolizumab and axitinib and avelumab (Bavencio) and axitinib, the benefit is seen irrespective of risk status.

For patients with good-risk disease, the combination of pembrolizumab and axitinib is a new standard of care. For patients with poor- or intermediate-risk disease, the discussion and subsequent decision to start pembrolizumab/axitinib versus nivolumab/ipilimumab will be more nuanced. Although the pembrolizumab/axitinib combination led to a 47% reduction in the risk of death versus sunitinib (Sutent) in the frontline setting, the data are very early. Also, nivolumab and ipilimumab led to a higher rate of complete response (CRs) than either IO/VEGF TKI combination, cautions McGregor. For this reason, longer-term follow up will be needed to see whether the partial responses observed in the primary analysis translate to a higher number of CRs.