Merck, Eisai get Japanese nod for cancer cocktail drug Keytruda, Lenvima

"This is the first approval of the KEYTRUDA plus LENVIMA combination in Japan," said Terushige Iike, President, Eisai Japan at Eisai. "We thank the patients, families and healthcare providers who made this approval possible. By delivering this combination therapy, we are proud to provide patients with advanced or recurrent endometrial carcinoma an additional treatment option."

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 (95% CI, 15.2-20.5) for KEYTRUDA plus LENVIMA versus 11.4 months (95% CI, 10.5-12.9) for chemotherapy. The median PFS was 7.2 months (95% CI, 5.7-7.6) for KEYTRUDA plus LENVIMA versus 3.8 months (95% CI, 3.6-4.2) for chemotherapy.

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and accounts for more than 90% of uterine cancers. In Japan, it is estimated there were more than 17,000 new cases of uterine cancer and more than 3,000 deaths in 2020 alone. KEYTRUDA and LENVIMA have each received orphan drug designation in Japan for endometrial carcinoma.

In addition to advanced endometrial carcinoma, Merck and Eisai continue to study the KEYTRUDA plus LENVIMA combination across several types of cancer with more than 20 clinical trials.