Pembrolizumab/Lenvatinib Combo Misses OS End Points in Select Advanced Melanoma and mCRC
Source: OncLive, April 2023
The phase 3 LEAP-003 (NCT03820986) and LEAP-017 (NCT04776148) trials evaluating pembrolizumab (Keytruda) plus lenvatinib (Lenvima) did not meet their primary end points of overall survival (OS) in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer (mCRC), respectively.
“With the LEAP-003 and LEAP-017 trials, we set out to help improve outcomes for patients with two difficult-to-treat advanced cancers, melanoma and CRC,” Corina Dutcus, MD, senior vice president of Clinical Development, Oncology at Eisai Inc., stated in a press release. “While these results are different from our initial expectation, insights from both studies will help contribute to our understanding of [pembrolizumab] plus [lenvatinib].”
The randomized, placebo-controlled, LEAP-003 trial enrolled patients with unresectable stage III or stage IV melanoma who had not received treatment for advanced or metastatic disease. Patients were required to have an ECOG performance status of 0 or 1, at least 1 measurable lesion by RECIST v1.1 criteria, and acceptable organ function.