US FDA grants breakthrough therapy designation to Lenvima plus Keytruda combination to treat patients with advanced unresectable HCC

Eisai, a leading global research and development-based pharmaceutical company and Merck & Co., Inc.,a leading global biopharmaceutical company Kenilworth, New Jersey, USA known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Lenvima, the orally available kinase inhibitor discovered by Eisai, in combination with Keytruda, Merck & Co., Inc.'s anti-PD-1 therapy, 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 Lenvima plus Keytruda combination. 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 breakthrough therapy designation is an FDA programme intended to expedite development and review of medicines for serious or life-threatening conditions. In order 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.

This breakthrough therapy designation is based on interim results from the Phase 1b trial Keynote-524/Study 116. An earlier interim analysis was presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting.

The combination of Lenvima plus Keytruda is investigational. The efficacy and safety of this combination has not been established. The Lenvima plus Keytruda combination is not approved in any cancer types today.

"We are excited that the FDA has recognized the importance of the activity seen with Lenvima plus Keytruda 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 & Co., to potentially bring another important option to patients."

"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 & Co., Inc., Kenilworth, NJ, USA 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 even more patients through a combination approach."



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