Posted by Michael Wonder on 01 Aug 2018
Eisai and Merck announce FDA grants breakthrough therapy designation for Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) as therapy for previously treated patients with advanced and/or metastatic non-MSI-H/pMMR endometrial carcinoma
31 July 2018 - Eisai and Merck announced today that the U.S. FDA granted breakthrough therapy designation for Lenvima (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma who have progressed following at least one prior systemic therapy.
The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck as part of the strategic collaboration announced in March 2018. This is the third Breakthrough Therapy designation for LENVIMA and the second Breakthrough Therapy designation for LENVIMA in combination with KEYTRUDA, following the Breakthrough Therapy designation for the combination for advanced and/or metastatic renal cell carcinoma announced in January 2018.
This Breakthrough Therapy designation was based on interim results of the EC cohort in Study 111/KEYNOTE-146, which were presented in June 2018 at the 54th American Society of Clinical Oncology (ASCO) Annual Meeting. Study 111/KEYNOTE-146 is a multicenter, open-label, single-arm Phase 1b/2 basket trial evaluating the efficacy and safety of LENVIMA in combination with KEYTRUDA in patients with selected solid tumors.
