A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

Trial ID #	NCT03797326; LEAP-005
Phase	II
Drug Class	Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name	Lenvatinib
Alternate Drug Names	MK-7902, Lenvima, ER-203492-00, E7080
Drugs in Trial	Lenvatinib, Pembrolizumab
Eligible Participant	Advanced solid tumors
Patients Enrolled	31 ovarian; median 3 prior therapies; 25 Pt-R/Pt-Rf; 39% HGSOC, 34% adenocarcinoma, 16% serous carcinoma (NOS), 3% OCCC, 3% CS, 3% LGSOC
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 35% (n=31) DoR: 9.2 months PFS: 6.2 months OS: 21.3 months Exploratory analysis, PD-L1 CPS: PD-L1 CPS<1: ORR: 50% (n=4) PD-L1 CPS≥1: ORR: 35% (n=26)
Clinically Significant Adverse Events	Serious AE: 1 death (hypovolemic shock) Grade 3-5 AE: any (77%), hypertension (19%), fatigue (10%)
Conclusion	Lenvatinib+pembrolizumab demonstrates encouraging efficacy and manageable safety in patients with heavily pretreated ovarian cancer, including those with prior platinum failure and those with previous bevacizumab exposure
Reference	Gonzales-Martin A et al. Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. Gynecol Oncol (2024) 186:182-190 https://pubmed.ncbi.nlm.nih.gov/38718741/