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

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/

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