Abstract No : Abstract #LBA44
Indication : Melanoma
Intervention : Lenvatinib
Company : Merck/Eisai
Technology : multiTKI
Results:
From Feb to Sep 2019, 103 pts were enrolled and treated; median age was 63 y, 67.0% had stage M1c/M1d disease, 55.3% had LDH >ULN (20.4% ≥2 × ULN), and 36.9% had BRAFV600 mutation. 61.2% received ≥2 prior therapies for MEL, 32.0% received prior BRAF ± MEK inhibition, and 28.2% had PD on prior anti–PD-1/L1 + anti–CTLA-4. Median study follow-up was 12.0 mo (range 8.7-15.6). Confirmed ORR by BICR was 21.4% (95% CI 13.9-30.5; 2 CRs, 20 PRs) overall and 31.0% (15.3-50.8; 1 CR, 8 PRs) for pts with PD on prior anti–PD-1/L1 + anti–CTLA-4. DCR was 65.0%. Median DOR was 6.3 mo (range 2.1+-11.1+); KM estimate of DOR ≥6 mo was 72.6%. Median (95% CI) PFS and OS were 4.2 mo (3.5-6.3) and 13.9 mo (95% CI 10.8-NR). 9-mo PFS and OS estimates were 26.2% and 65.4%. Most common treatment-related AEs (TRAEs) were hypertension (56.3%), diarrhea (35.9%), and nausea (34.0%). TRAEs were gr 3-5 in 44.7%, gr 5 in 1.0%, and led to discontinuation of len and/or pembro in 7.8%.
Conclusion:
The combination of len and pembro has activity in pts with advanced MEL with confirmed progression on a PD-1/L1 inhibitor, including those with PD on combined anti–PD-1/L1 + anti–CTLA-4. The safety profile was consistent with prior studies. These data support len + pembro as a potential regimen for this population of high unmet need.
