Eisai, Merck & Co to expand enrolment of study for lenvima, pembrolizumab

Eisai Co., Ltd. has announced that it has signed an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside of the United States and Canada) to increase the target number of endometrial carcinoma patients to be enrolled in a Phase Ib/II clinical study of its in-house discovered and developed multi-kinase inhibitor lenvatinib mesylate (product names: Lenvima/ Kisplyx, "lenvatinib") in combination with anti-PD-1 therapy pembrolizumab (brand name: KEYTRUDA), developed by Merck & Co., Inc., Kenilworth, NJ, US, due to encouraging initial data.

The decision to expand the target number of enrolled patients is based on favourable interim analysis results of the endometrial cohort in a Phase Ib/II study (Study 111) of lenvatinib in combination with pembrolizumab for multiple solid cancers, which is being jointly conducted by Eisai and Merck & Co., Inc., Kenilworth, NJ, US. The interim analysis (n = 23)(1) results indicated an objective response rate* to the combination therapy at 24 weeks of 52.2% (95% CI = 30.6 – 73.2) based on independent radiologic review and 47.8% (95% CI = 26.8 – 69.4) based on investigator review. Additionally, tumour regression was observed regardless of the state of microsatellite instability. In this study, the most frequently observed adverse events (Top 5) were hypertension, fatigue, arthralgia, diarrhea, and nausea. Based on the results of the interim analysis of Study 111, the target number of enrolled endometrial carcinoma patients will be increased to approximately 100. Patient enrolment is already underway.

Endometrial carcinoma is the sixth most common cancer in women worldwide, with 320,000 new cases diagnosed in 2012.(2) In the United States, it is estimated that there will be 60,000 new cases and 10,000 deaths by endometrial carcinoma in 2017.(3) There currently is no drug approved in 2nd line and this is where the unmet need lies.