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 ( 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.

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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.