The LEAP-003 trial will be discontinued based on the recommendation of an independent data monitoring committee, and the primary endpoint was not met in the LEAP-017 trial.
The LEAP-003 trial (ClinicalTrials.gov Identifier: NCT03820986) was designed to evaluate pembrolizumab and lenvatinib as first-line treatment for adults with unresectable or metastatic melanoma. Patients in this trial were randomly assigned to receive pembrolizumab plus lenvatinib or pembrolizumab plus placebo.
The dual primary endpoints were overall survival (OS) and progression free survival (PFS). In an earlier analysis, pembrolizumab plus lenvatinib led to a significant improvement in PFS vs pembrolizumab alone, but the most recent analysis showed no improvement in OS with the combination.
In the LEAP-017 trial (ClinicalTrials.gov Identifier: NCT04776148), the combination of pembrolizumab and lenvatinib was compared with standard of care (regorafenib or trifluridine and tipiracil hydrochloride) for the treatment of patients with unresectable and metastatic colorectal cancer (that is not mismatch repair-deficient or microsatellite instability-high) who experienced disease progression on, or became intolerant to, prior therapy. The primary endpoint of the trial was OS.
Findings from the final prespecified analysis showed a trend toward improvement in OS with pembrolizumab plus lenvatinib, though the results did not meet statistical significance. Similarly, the combination was associated with a trend toward improvement in PFS, objective response rate, and duration of response. However, these results were not tested for statistical significance.
The companies noted that results from both trials will be shared with the scientific community following further evaluation of the data.
Merck and Eisai provide update on phase 3 trials of Keytruda® (pembrolizumab) plus Lenvima® (lenvatinib) in certain patients with advanced melanoma (LEAP-003) and metastatic colorectal cancer (LEAP-017). News release. Merck. April 7, 2023. https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-trials-of-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-certain-patients-with-advanced-melanoma-leap-003-and-metastatic-colorectal-cance/
This article originally appeared on MPR