Lenvatinib (Lenvima) plus pembrolizumab (Keytruda) showed early antitumor activity and tolerability in previously treated patients with advanced solid tumors, according to interim results from the phase 2 LEAP-005 trial (NCT03797326) presented during the virtual 2020 ESMO Congress.1

Results showed that the objective response rate (ORR) with the combination per RECIST v1.1 criteria and blinded independent central review (BICR) was 29.0% (95% CI, 14.2%-48.0%) in 31 patients with triple-negative breast cancer (TNBC) who received treatment in the second- or third-line setting. The ORR was even higher, at 32.3% (95% CI, 16.7%-51.4%) in 21 patients with ovarian cancer who received the combination as their fourth line of treatment. Moreover, the ORRs were 9.7% (95% CI, 2.0%-25.8%) in 21 patients with third-line gastric cancer, 21.9% (95% CI, 9.3%-40.0%) in 32 patients with third-line colorectal cancer (CRC), and 9.7% (95% CI, 2.0%-25.8%) in 31 patients with second-line biliary tract cancer. In 31 patients with second-line glioblastoma multiforme, the ORR was 16.1% (95% CI, 5.5%-33.7%).

“The prespecified futility efficacy criteria for cohort expansion were met and toxicity was manageable in all cohorts,” Zarnie Lwin, MD, lead investigator of the trial and medical oncologist in the Department of Medical Oncology at the Royal Brisbane and Women’s Hospital, of the University of Queensland, in Australia, said in a virtual presentation during the meeting. “LEAP-005 will continue to assess the efficacy and safety of lenvatinib plus pembrolizumab in patients with previously treated advanced solid tumors in expanded cohorts of 100 patients each.”

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