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LEAP-005: Phase II study of lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with previously treated advanced solid tumours
Lwin, Z. Gomez-Roca, C. Saada-Bouzid, E. Yanez, E. Munoz, F. L. Im, S. A. Castanon, E. Senellart, H. Graham, Donna Voss, M.
Lwin, Z.
Gomez-Roca, C.
Saada-Bouzid, E.
Yanez, E.
Munoz, F. L.
Im, S. A.
Castanon, E.
Senellart, H.
Graham, Donna
Voss, M.
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Abstract
Background: Len (antiangiogenic multiple receptor tyrosine kinase inhibitor) +
pembro (anti‒PD-1 agent) showed promising clinical outcomes across several cancers
in early-phase trials and is FDA-approved for pts with previously treated advanced
endometrial cancer that is not MSI-H or mismatch repair-deficient who are ineligible
for curative surgery/radiation. We report the first results from the phase 2 LEAP-005
study (NCT03797326), which evaluates the efficacy and safety of len + pembro in pts
with select previously treated advanced solid tumors.
Methods: This open-label, multicohort study enrolled pts aged 18 y with one of the
following previously treated, histologically/cytologically confirmed advanced tumors:
triple negative breast (TNBC), ovarian, gastric, colorectal (non-MSI-H/mismatch repair
proficient), glioblastoma multiforme (GBM), or biliary tract (BTC; ampulla of Vater
excluded). Pts received len 20 mg/d + pembro 200 mg Q3W for 35 cycles or until
confirmed PD or unacceptable toxicity. Primary endpoints are ORR by blinded independent
central review per RECIST v1.1 or RANO (GBM only), and safety.
Results: 187 pts have been enrolled in LEAP-005. Median study follow-up at Apr 10,
2020 data cutoff was 8.6 (range, 1.9‒13.1) mo. Encouraging efficacy was observed
across cohorts, and toxicity was manageable (Table).
Conclusions: Len + pembro showed promising antitumor activity and manageable
toxicity across the previously treated tumor cohorts evaluated in LEAP-005. The study
is ongoing; all cohorts will expand to enroll 100 pts/cohort.
Description
Date
2020
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Article
Citation
Lwin Z, Gomez-Roca C, Saada-Bouzid E, Yanez E, Muñoz FL, Im SA, et al. LBA41 LEAP-005: Phase II study of lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with previously treated advanced solid tumours. Annals of Oncology. 2020;31:S1170-S.