Merck’s Keytruda-Lenvima Combination Shows Promise in Liver Cancer Treatment

Breakthrough Therapy Designation:
The FDA granted Breakthrough Therapy Designation to the combination of LENVIMA (lenvatinib mesylate) and KEYTRUDA (pembrolizumab) for advanced and/or metastatic renal cell carcinoma in 2018.

Clinical Trial Success:
The Phase 3 LEAP-012 trial demonstrated that KEYTRUDA plus LENVIMA in combination with transarterial chemoembolization (TACE) significantly improved progression-free survival compared to TACE alone in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

Combination Therapy Potential:
The combination of KEYTRUDA and LENVIMA has shown potential in treating various types of cancer, including renal cell carcinoma and hepatocellular carcinoma, through the LEAP clinical program.

Liver Cancer Statistics:
Liver cancer is a leading cause of cancer-related deaths worldwide, with an estimated 865,000 new cases and 757,000 deaths globally in 2022. The five-year relative survival rate for liver cancer in the U.S. is 22%.

Previous Trial Failures:
The combination of KEYTRUDA and LENVIMA failed to meet its primary endpoints in the Phase 3 LEAP-002 trial for first-line treatment of unresectable hepatocellular carcinoma, but the companies remain committed to exploring the potential of this combination.