NICE has published draft guidance which does not recommend pembrolizumab (Keytruda) with axitinib (Inlyta) for untreated advanced renal cell carcinoma (RCC) in adults.
NICE concluded that there is uncertainty around the long-term benefit of the treatment, and this leads to uncertainty regarding cost-effectiveness estimates.
The clinical evidence came from KEYNOTE‑426, an open-label, randomised phase 3 trial that compared pembrolizumab plus axitinib with sunitinib in untreated renal cell carcinoma (median follow-up 12.8 months).
The NICE committee acknowledged that pembrolizumab with axitinib was more effective than sunitinib for overall survival (HR 0.53; 95% CI 0.38-0.74; P=0.00005) and progression-free survival (HR 0.69; 95% CI 0.57-0.84; P=0.00014), but noted that the data are immature. Median survival was not reached in either arm.
Uncertainties in the clinical evidence would not be resolved through data collection in the Cancer Drugs Fund (CDF), the committee said. Hence, pembrolizumab with axitinib is not recommended for use in the CDF.
The guidance is open for public consultation until 4 March 2020.