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2023-04-10| Trials & Approvals

Merck, Eisai’s Keytruda-Lenvima Combo Fails in Melanoma and Colorectal Cancer Trials

by Nai Ye Yeat
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Two phase 3 clinical trials investigating Keytruda (pembrolizumab) plus Lenvima (lenvatinib) are announced to stop, as interim analyses showed that they failed to reach main goals, according to a press release from Merck, the manufacturer of Keytruda.  

Combining Keytruda and Lenvima For Cancer Treatment

Previously, the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai has shown better outcomes than chemotherapy for patients with pretreated advanced endometrial cancer. The combination therapy then gained approval in the US, the EU, Japan, and other countries for treating advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. 

The efficacy of the combination is also being studied in other malignancies such as hepatocellular carcinoma, non-small cell lung cancer, head and neck cancer, and colorectal cancer across more than 10 clinical trials through the LEAP (LEnvatinib And Pembrolizumab) clinical program. Unfortunately, two of them, LEAP-003 and LEAP-017 trials, seem to fail in recent reports.

Related article: Merck and Eisai Come Up Short in the Clinic with Liver Cancer Combination Therapy

The Primary Goals Left Unmet

In the randomized, placebo-controlled phase 3 LEAP-003 trial, investigators evaluated Keytruda plus Lenvima compared with Keytruda alone as a first-line treatment for adult patients with unresectable or metastatic melanoma.  

However, the interim analysis did not show that the drug duo improved overall survival (the time during and after treatment until the death of any cause) despite the other primary endpoint, progression-free survival (the time from treatment until disease worsens or spreads) was met, as an earlier analysis of LEAP-003 showed that there was a significant improvement in the Keytruda/Lenvima group compared to the Keytruda alone group.

Then in the phase 3 LEAP-017 trial, Keytruda plus Lenvima was compared with regorafenib (Stivarga) or TAS-102 for patients with unresectable and metastatic colorectal cancer (MCC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) whose disease gets worse or stops responding to prior therapy.

While an analysis of LEAP-017 findings showed that Keytruda plus Lenvima displayed a trend toward improved overall survival, progression-free survival, and objective response rate (the percentage of patients whose disease shrinks or disappears from treatment) and duration of response, the difference between the different treatment groups was not statistically significant, meaning that the researchers could not tell that one regimen is superior.  

Although the results differ from initial expectations, researchers are still confident that insights from both studies will help contribute to their understanding of combination therapy. Further evaluation will be carried out in ongoing trials within the LEAP program.

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