Lenvitinib and pebrolizumab for endometrial cancer – pro
The FDA has granted an accelerated approval to the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy. The indication applies to patients who are not candidates for curative surgery or radiation and who have disease that is not microsatellite instabilityhigh (MSI-H) or mismatch repair deficient (dMMR). This si not a full FDA approval, but an accelerated approval.
The approval was supported by findings from the single-arm, multicenter, open-label, multi-cohort phase Ib/II Study 111/KEYNOTE-146 trial (NCT02501096), which evaluated 108 patients with previously treated metastatic endometrial cancer treated with lenvatinib and pembrolizumab.2Patients received 20 mg lenvatinib orally once daily plus 200 mg pembrolizumab given intravenously every 3 weeks until disease progression or unacceptable toxicity.
Overall, 87% of patients had nonMSI-H/dMMR tumors, whereas 10% did, and the remaining patients had unknown MSI/MMR status.
Makker V, Rasco D, Vogelzang NJ, et al. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial.Lancet Oncol.2019;20(5):711-718. doi: 10.1016/S1470-2045(19)30020-8.