This is the second trial in less than a month studying Keytruda that failed to meet endpoints.
The phase 3 LEAP-002 trial investigating Merck’s Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) did not meet its endpoints of overall survival and progression-free survival as a first-line treatment for patients with unresectable hepatocellular carcinoma. The combination compared with Lenvima alone trended toward improvement in overall survival and progression-free survival for patients but did not meet statistical significance.
This is the second Keytruda trial failure that Merck has announced in less than a month. In July, Keytruda failed to meet the primary endpoint of event-free survival for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). The phase 3 KEYNOTE-412 trial was evaluating Keytruda with concurrent chemoradiation therapy followed by Keytruda as maintenance therapy.
In the LEAP-002 study, the median overall survival of the Lenvima monotherapy arm was longer than that observed in previously reported clinical trials evaluating this therapy as a monotherapy in unresectable hepatocellular carcinoma. The safety profile of Keytruda/Lenvima was consistent with previously reported data on the combination.
“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,” Gregory Lubiniecki, M.D., vice president, global clinical development, Merck Research Laboratorie, said in a press release. “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.”
In the United States, the Keytruda/Lenvima combination is approved to treat patients with advanced endometrial carcinoma who have disease progression and for adult patients with advanced renal cell carcinoma in the first-line setting.
Hepatocellular carcinoma is the most common type of primary liver cancer and the most rapidly increasing cause of cancer deaths in the United States. Hepatocellular carcinoma accounts for approximately 90% of primary liver cancers. It is estimated there were more than 905,000 new cases of liver cancer and more than 830,000 deaths from the disease globally in 2020.
Merck and Eisai are also studying the Keytruda/Lenvima 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.