A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer

Trial ID # NCT04519151
Phase II
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Pembrolizumab
Alternate Drug Names Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial Lenvatinib, Pembrolizumab
Eligible Participant

Platinum sensitive high grade serous or endometrioid ovarian cancer

Patients Enrolled

24, median 2 prior therapies (1-2), 50% w/ prior bevacizumab

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, OS, evaluated per RECIST

Efficacy

ORR: 54% (3CR, 10PR)
DCR: 83.3% (3CR, 10PR, 7SD)
PFS: 5.5 months
DoR: 8 months
OS: 30 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: overall (67%), hypertension (42%)

Conclusion

The combination of lenvatinib and pembrolizumab shows meaningful responses and manageable toxicity in platinum sensitive recurrent high grade serous OC patients thus potentially provides a non chemotherapy alternative

Reference

Bauer S et al. Phase II study of pembrolizumab and lenvatinib in platinum sensitive recurrent ovarian cancer. J Clin Oncol 42, 2024 (suppl 16; abstr 5581)
https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5581

Bauer S et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2024/06/len-pem-Pt-S-ASCO-2024-poster.pdf

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