Dr. Lwin on the Design of the LEAP-005 Trial in Pretreated Advanced Solid Tumors

Zarnie Lwin, MBBS, FRACP, associate professor, senior staff specialist, medical oncologist, Cancer Care Services, Royal Brisbane and Women’s Hospital, University of Queensland, Australia, discusses the design of the phase 2 LEAP-005 trial in previously treated patients with advanced solid tumors.

During the 2020 ESMO Virtual Congress, interim results from the LEAP-005 trial were presented. The trial met the prespecified futility efficacy criteria for expansion. Additionally, the investigators reported manageable toxicity with combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in the 6 cohorts of patients with previously treated advanced solid tumors.

The study evaluated the combination in patients with pretreated triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, biliary tract cancer, and glioblastoma.

Initial enrollment included 30 patients per cohort, says Lwin. Patients received 200 mg of intravenous pembrolizumab every 3 weeks plus 20 mg of daily, oral lenvatinib for up to 35 cycles. 

All prespecified efficacy end points were met, so each cohort will enroll 100 patients in the expansion phase, concludes Lwin.