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Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-002 Trial

TOKYO and RAHWAY, N.J., Aug 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada) today announced that the Phase 3 LEAP-002 trial investigating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received LENVIMA plus KEYTRUDA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported data on the combination. Eisai and Merck & Co., Inc., Rahway, NJ, USA plan to present these data at an upcoming medical conference.

“Our joint clinical development program for KEYTRUDA plus LENVIMA is designed to address unmet needs for some of the most challenging-to-treat types of cancer, like hepatocellular carcinoma,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA Research Laboratories. “We remain confident in the potential of this combination based on the body of evidence we’ve seen to date and will continue to investigate its role across multiple types of cancer.”

“Aiming for further improvement in the treatment of patients with unresectable HCC, we selected LENVIMA monotherapy, a standard of care option, as the control arm of the LEAP-002 trial,” said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology at Eisai Inc. “While results evaluating the combination are not what we had hoped for, we will continue to contribute to the care of patients with unresectable HCC by applying valuable knowledge from the LEAP-002 trial.”

LENVIMA monotherapy is approved for the first-line treatment of patients with uHCC in the U.S., Europe, and China, and for patients with uHCC in Japan. The approval of LENVIMA was based on results of the Phase 3 REFLECT trial which evaluated the efficacy and safety of LENVIMA versus sorafenib for the first-line treatment of patients with uHCC.

In the U.S., LENVIMA plus KEYTRUDA is approved for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation and for adult patients with advanced renal cell carcinoma (RCC) in the first-line setting. In Europe, LENVIMA (marketed as KISPLYX for RCC in the EU) plus KEYTRUDA is approved for adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum containing therapy in any setting and are not candidates for curative surgery or radiation and for adults with advanced RCC in the first-line setting. The LENVIMA plus KEYTRUDA combination is also approved in Japan for patients with radically unresectable or metastatic RCC and patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. Results from the LEAP-002 trial do not affect the current approved indications for the LENVIMA and KEYTRUDA combination.

Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer, biliary tract cancer, colorectal cancer, gastric cancer, esophageal cancer, glioblastoma and pancreatic cancer) across more than 15 clinical trials.

For more information, visit www.eisai.com/news/2022/pdf/enews202259pdf.pdf.

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