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
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 Pembrolizumab, Lenvatinib
Eligible Participant

Advanced solid tumors

Patients Enrolled

31 ovarian; median 3 prior therapies; 25 Pt-R

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS, evaluated per RECIST

Efficacy

ORR: 32% (n=31)
DCR: 74% (n=31)
PFS: 4.4. months

Exploratory analysis, Pt-status, prior Bevacizumab:
Pt-R (n=25): ORR: 24%
Prior Bev (n=19): 21%

Clinically Significant Adverse Events

Serious AE: 1 death (hypovolemic shock)
Grade 3-5 AE: any (68%), 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. Efficacy and Safety of Lenvatinib Plus Pembrolizumab in Patients with Previously Treated Ovarian Cancer in the Multicohort Phase 2 LEAP-005 Study. IGCS (2020) Plenary I, abstract 2
https://www.clearityfoundation.org/wp-content/uploads/2020/09/Lenvatinib-and-Pembro-IGCS-2020-abs.pdf

Gonzales-Martin A et al. Table from abstract
https://www.clearityfoundation.org/wp-content/uploads/2020/09/Lenvatinib-and-Pembro-IGCS-2020-Table.pdf

Lwin Z et al. LEAP-005: Phase II study of lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with previously treated advanced solid tumours. Annals Oncol (2020) 31 (suppl_4): abstract LBA41
https://www.clearityfoundation.org/wp-content/uploads/2020/10/Lenvatinib-Pembro-ESMO-2020-abstract.pdf

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