Zarnie Lwin, MD Royal Brisbane, and Women’s Hospital, University of Queensland discusses the ESMO abstract LBA41 – LEAP-005: Phase II study of lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with previously treated advanced solid tumours.
Context
In early-phase studies, Len (antiangiogenic multiple receptor tyrosine kinase inhibitor) + pembro (anti-PD-1 agent) showed promising clinical results across several cancers and is FDA-approved for pts with previously treated advanced endometrial cancer that is not MSI-H or mismatch repair-deficient that are ineligible for curative / radiation surgery. The first findings of the phase 2 LEAP-005 study (NCT03797326) evaluating the efficacy and protection of len + pembro in pts with selected advanced solid tumors previously treated are published.
Methodology
This open-label, multi-cohort research included pts aged 18 y with one of the following advanced tumors previously treated, histologically / cytologically confirmed: triple-negative breast (TNBC), ovarian, gastric, colorectal (non-MSI-H / mismatch repair proficient), glioblastoma multiforme (GBM), or biliary tract (BTC; Vater ampulla excluded). Len 20 mg / d + pembro 200 mg Q3W was administered to Pts for 35 cycles or until confirmed PD or unacceptable toxicity. ORR by blinded impartial central examination per RECIST v1.1 or RANO (GBM only) and protection are the primary endpoints.
Outcomes
In LEAP-005, 187 pts were inscribed. The median follow-up analysis at the data cutoff of Apr 10, 2020 was 8.6 (range, 1.9-13.1) mo. Encouraging effectiveness across cohorts was observed, and toxicity was manageable.
Findings
Across the previously treated tumor cohorts tested in LEAP-005, Len + pembro demonstrated encouraging antitumor activity and manageable toxicity. The research is ongoing; all cohorts will extend to include approximately 100 pts per cohort.
Identification of Clinical Trial NCT’s03797326.