Merck, Eisai Update Phase 3 LEAP-012 Liver Cancer Trial

Merck, known as MSD outside of the United States and Canada, and Eisai announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

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At a pre-specified interim analysis, KEYTRUDA plus LENVIMA in combination with TACE did not achieve statistical significance for overall survival (OS), one of the study’s primary endpoints, compared to TACE alone. The likelihood of reaching the protocol-specified threshold for statistical significance for OS at a future analysis was evaluated by Merck and Eisai and considered to be low. On this basis, the study will be closed, and the companies are informing investigators of this decision. The safety profile of the KEYTRUDA plus LENVIMA-based regimen was consistent with that observed in previously reported studies evaluating the combination and in earlier analyses of LEAP-012. Further analysis of the data is ongoing; Merck and Eisai will work with investigators to share the results with the scientific community.

As reported previously, KEYTRUDA plus LENVIMA in combination with TACE met the study’s other primary endpoint of progression-free survival (PFS) and demonstrated a statistically significant and clinically meaningful improvement compared to TACE alone. Data from this first interim analysis, which served as the final analysis for the endpoint of PFS, were presented at the European Society for Medical Oncology (ESMO) Congress 2024 and published in The Lancet. With additional follow-up at subsequent analyses, PFS remained consistent.

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“Although the progression-free survival results from this study are encouraging, unfortunately, the addition of KEYTRUDA plus LENVIMA to TACE did not show the overall survival benefit we hoped,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “We are grateful to the patients and investigators for their important contributions to this study, and our commitment is unwavering as we pursue new therapeutic options for people living with hepatocellular carcinoma, an aggressive and challenging-to-treat cancer.”

“The overall survival findings from LEAP-012, along with the previously reported improvement in progression-free survival, provide important insights for treating unresectable, non-metastatic hepatocellular carcinoma,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. “For years, TACE has been a standard of care for these patients, yet many experience disease progression within twelve months. With LEAP-012, we sought to make a meaningful difference for this patient population. LENVIMA continues to play an important role as a monotherapy treatment option for patients with unresectable HCC, and as a company with a deep heritage in liver cancer research, Eisai remains committed to advancing the science.”

In June 2025, KEYTRUDA plus LENVIMA in combination with TACE was approved in China to treat unresectable non-metastatic HCC. KEYTRUDA plus LENVIMA is approved in the U.S., the European Union (EU), Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is approved as KISPLYX for advanced RCC in the EU. Results from the LEAP-012 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination, including the approval of KEYTRUDA plus LENVIMA in combination with TACE in China to treat unresectable non-metastatic HCC.

LENVIMA monotherapy is approved for the treatment of patients with unresectable HCC in more than 80 countries and regions, including in the U.S., the EU, China and Japan.

KEYTRUDA is approved as a monotherapy for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen in the U.S. and as a monotherapy for the treatment of patients with HCC who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy in China.

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Source- businesswire