Merck And Eisai Receive Third Breakthrough Therapy Designation From FDA For KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Treatment

Designation Granted for Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment. This is the third Breakthrough Therapy designation for the KEYTRUDA plus LENVIMA combination and is based on updated interim results from the Phase 1b trial KEYNOTE-524/Study 116. An earlier interim analysis was presented at the American Association for Cancer Research (AACR) Annual Meeting 2019. The first two Breakthrough Therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma, received in January 2018 and July 2018, respectively. The combination of KEYTRUDA plus LENVIMA is investigational. The efficacy and safety of this combination has not been established. The KEYTRUDA plus LENVIMA combination is not approved in any cancer types today.

“As part of our ongoing collaboration with Eisai, we are committed to evaluating the potential of KEYTRUDA plus LENVIMA across a number of different types of cancer,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. “With this Breakthrough Therapy designation from the FDA, we look forward to working with Eisai to potentially build upon our existing indications for this difficult-to-treat cancer, so that we can help patients through a combination approach.”

“We are excited that the FDA has recognized the potential of KEYTRUDA plus LENVIMA in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this Breakthrough Therapy designation,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. “We are dedicated to working together with Merck to potentially bring another important option to patients.”

The Breakthrough Therapy designation is intended to expedite development and review of medicines for serious or life-threatening conditions and to qualify for this designation, preliminary clinical evidence must demonstrate that the therapy may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. – Bio Space

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