New Reference: Lenvatinib with Pembrolizumab in Head and Neck Cancer

This phase III study evaluated lenvatinib plus pembrolizumab versus placebo plus pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. The addition of lenvatinib improved objective response rate and progression-free survival but did not improve overall survival. The safety profile was consistent with known data, with more high-grade adverse events and treatment discontinuations in the combination arm.

Study

Randomized, double-blind, placebo-controlled, phase III study [LEAP-010]

PD-L1 CPS >1% head and neck SCC deemed incurable by local therapy

Lenvatinib plus pembrolizumab n=256) vs placebo plus pembrolizumab (n=255)

Efficacy

ORR: 46% vs 25% (lenvatinib+pembro vs. placebo+pembro)

CR: 15% vs 10%

mPFS: 6.2 mos vs 2.8 mos (HR 0.64 [0.50-0.81])

mOS: 15.0 mos vs 17.9 mos (HR 1.15 [0.91-1.45])

Safety

Grade >=3 AE: Hypertension (21% vs 8%), diarrhea (25% vs 13%), weight decreased (21% vs 13%), proteinuria (21% vs 6%), constipation (22% vs 18%), hyponatremia (13% vs 8%), dysphagia (11% vs 9%), cough (16% vs 9%)

Serious AEs occurred in 67% vs 38%

Treatment-related deaths: 3% vs 1%