|The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2021 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Lenvatinib plus pembrolizumab demonstrated promising antitumor activity with a manageable safety profile in patients with previously treated advanced non–microsatellite instability-high (MSI-H)/mismatch repair proficient (pMMR) colorectal cancer (CRC), according to results from the CRC cohort of the LEAP-005 study, presented at the 2021 Gastrointestinal Cancers Symposium.
The LEAP-005 trial’s (ClinicalTrials.gov identifier: NCT03797326) CRC cohort included 32 individuals (median patient age, 56 years) with histologically/cytologically confirmed metastatic and/or unresectable non-MSI-H/pMMR disease who received prior oxaliplatin and irinotecan. LEAP-005 investigators administered lenvatinib at 20 mg once daily plus 200 mg of pembrolizumab every 3 weeks for up to 35 cycles of pembrolizumab therapy (~2 years). The median time from first dose to data cutoff (April 10, 2020) was 10.6 months (range, 5.9-13.1).
Results showed that the objective response rate—the study’s primary end point—was 22% (95% CI, 9-40). There were no complete responses and 7 partial responses.
Secondary end points included the disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The DCR was 47% (95% CI, 29-65), and the DOR had not been reached at the time of the data cutoff. The median PFS with the doublet regimen was 2.3 months (95% CI, 2.0-5.2); the median OS, 7.5 months (95% CI, 3.9-not reached).
Forty-seven percent of patients reported a grade 3 or 4 treatment-related adverse event (TRAE) and 50% of patients experienced grade 3 to 5 TRAEs, which led to treatment discontinuation in 3 patients. Of the 3 patients who discontinued therapy, 1 patient had a grade 2 ischemic stroke; 1 patient had grade 3 increased liver transaminases; and 1 patient had grade 5 intestinal perforation.
The 5 most common AEs (all-grade, affecting ≥5% of patients) were hypertension (47%), hepatotoxicity (34%), proteinuria (34%), and hypothyroidism (28%), and hemorrhage (22%).
Based on these data, enrollment in the CRC cohort has been expanded to 100 patients, according to Carlos Alberto Gomez-Roca, MD, who presented the findings.
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study. This clinical trial was supported by Merck Sharp & Dohme Corp.
Read more of Cancer Therapy Advisor‘s coverage of the ASCO GI 2021 meeting by visiting the conference page.
Gomez-Roca C, Yanez E, I S-A, et al. LEAP-005: a phase II multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—results from the colorectal cancer cohort. Presented at: Gastrointestinal Cancers Symposium; January 15-17, 2020. Abstract 94.