Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA for LENVIMA plus KEYTRUDA Combination Treatment.
ENPNewswire-July 24, 2019--Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA for LENVIMA plus KEYTRUDA Combination Treatment
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Release date- 23072019 - Tokyo and Kenilworth - Eisai (Headquarters: Tokyo, CEO: Haruo Naito), and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. 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., Kenilworth, N.J., U.S.A.'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 program 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., Inc., Kenilworth, N.J., U.S.A. 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, N.J., U.S.A. 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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About KEYNOTE-524/Study 116
KEYNOTE-524/Study 116 is a multi-center, open-label, single-arm Phase 1b study evaluating the safety and efficacy of the combination of LENVIMA (12 mg/day for patients weighing 60 kg or more, and 8 mg/day for patients weighing less than 60 kg) and KEYTRUDA (200 mg intravenously every three weeks) in patients with unresectable HCC, Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for transarterial chemoembolization [TACE]) or C, Child-Pugh class A, and ECOG performance status (PS) of 0 or 1. The primary endpoints are tolerability and safety, and the secondary endpoints include overall survival (OS), objective response rate (ORR), progression-free survival (PFS) and time to progression (TTP) using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria. Tumor assessments of complete response (CR) or partial response (PR) were confirmed at least four weeks (or longer) after initial response. The first part of the trial evaluated tolerability by assessing dose-limiting toxicities (DLTs) during the first cycle of treatment in patients for whom no other appropriate therapy was available. After tolerability was confirmed, additional patients with no prior systemic therapy...
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