As of November 1st 2023, pembrolizumab (KEYTRUDA®), in combination with lenvatinib (KISPLYX®), is reimbursed in Belgium for the first-line treatment of patients with advanced renal cell carcinoma (aRCC) with intermediate or poor prognosis.
Reimbursement is based on the positive results from the phase III CLEAR study. In this trial, the combination of pembrolizumab and lenvatinib resulted in a 4-times longer progression-free survival (PFS) as compared to sunitinib (median PFS 22.1 vs. 5.9 months, HR[95%CI]: 0.43[0.34-0.55], p< 0.001) in the intermediate and poor risk populations. Furthermore, in those populations there was a median gain in overall survival of 13.6 months (47.9 vs. 34.3 months, HR[95%CI]: 0.74[0.57-0.96]). In the intention-to-treat population, the combination of pembrolizumab and lenvatinib resulted in an objective response rate of 71.3%, with a complete response rate of 18.3%.
Detailed reimbursement criteria can be consulted on the RIZIV/INAMI website.
Motzer RJ, et al. Presented at ASCO 2023; Abstract 4502.