Pembrolizumab with or Without Lenvatinib As First-line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Phase 3 LEAP-010 Study

The PD-1 inhibitor pembrolizumab (pembro) is approved as first-line monotherapy for patients (pts) with PD-L1-expressing R/M HNSCC (PD-L1 combined positivity score [CPS] ≥1). A phase 1b/2 study of pembro plus the multikinase inhibitor lenvatinib (len) showed promising antitumor activity and manageable toxicity in pts with HNSCC. In LEAP-010, a phase 3, randomized, placebo-controlled, double-blind study, we hypothesized that first-line len + pembro would improv e efficacy compared with placebo + pembro, and have a manageable safety profile, in pts with PD-L1 CPS ≥1 R/M HNSCC (NCT04199104).

Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: L. Licitra, M. Tahara, K. Harrington, M. Olivera Hurtado de Mendoza, Y. Guo, S. Aksoy, M. Fang, B. Żurawski, T. Csőszi, M. Klochikhin, T.B. de Oliveira, S. Takahashi, M.H. Yang, P.L. Swiecicki, K. O'Hara, J. Shen, A. Wang, B. Gumuscu, K. Benjamin, R.I. Tags: 1 Source Type: research