EC nod for Lenvima plus Keytruda in two indications

The European Commission has approved the combination of Lenvima (lenvatinib mesylate; trade named Kisplyx in the European Union), the orally available multiple receptor tyrosine kinase inhibitor discovered by Japan’s Eisai (TYO: 4523), plus Keytruda (pembrolizumab), the anti-PD-1 therapy from Merck & Co (NYSE: MRK), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The approval for advanced RCC is based on results from the pivotal Phase III CLEAR (Study 307)/KEYNOTE-581 trial, in which Lenvima plus Keytruda demonstrated statistically-significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p<0.0001) with a median PFS of 23.9 months versus 9.2 months for sunitinib, and overall survival (OS), reducing the risk of death by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=0.0049) versus sunitinib.

Median OS was not reached at the time of analysis in either study arm. The objective response rate (ORR) was 71% (95% CI: 66-76) for patients treated with Lenvima plus Keytruda (n=355) versus 36% (95% CI: 31-41) for patients treated with sunitinib (n=357; p<0.0001). Patients treated with Lenvima plus Keytruda achieved a complete response (CR) rate of 16% and partial response (PR) rate of 55% versus a CR rate of 4% and a PR rate of 32% for patients treated with sunitinib.