European Commission approves Lenvima + Keytruda to treat endometrial carcinoma – Eisai + Merck Inc.

Eisai Co., Ltd. and Merck Inc., announced that the European Commission has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck Inc., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma.

The approval is based on results from the pivotal Phase III Study 309/KEYNOTE-775 trial, in which Lenvima plus Keytruda demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p<0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 44% (HR=0.56 [95% CI, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). The median OS was 18.3 months for Lenvima plus Keytruda versus 11.4 months for chemotherapy. The median PFS was 7.2 months for Lenvima plus Keytruda versus 3.8 months for chemotherapy. The objective response rate (ORR) was 32%
(95% CI, 27-37) for patients treated with Lenvima plus Keytruda versus 15% (95% CI, 11- 18) for patients treated with chemotherapy (p<0.0001). Patients treated with Lenvima plus Keytruda achieved a complete response (CR) rate of 7% and partial response (PR) rate of 25% versus a CR rate of 3% and a PR rate of 12% for patients treated with chemotherapy.