European Commission Approves KEYTRUDA Plus LENVIMA for Patients With Endometrial Carcinoma

Merck and Eisai announced that the European Commission has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, 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 an immunotherapy with a tyrosine kinase inhibitor approved in Europe for these patients with advanced or recurrent endometrial carcinoma.

The approval is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA 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 KEYTRUDA plus LENVIMA versus 11.4 months for chemotherapy. The median PFS was 7.2 months for KEYTRUDA plus LENVIMA versus 3.8 months for chemotherapy. The objective response rate (ORR) was 32% (95% CI, 27-37) for patients treated with KEYTRUDA plus LENVIMA versus 15% (95% CI, 11-18) for patients treated with chemotherapy (p<0.0001). Patients treated with KEYTRUDA plus LENVIMA 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.

“This approval is welcome news for patients in Europe and is based on the first Phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy,” said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck Research Laboratories. “Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in KEYTRUDA plus LENVIMA that demonstrated a 38% reduction in risk of death compared to chemotherapy alone."