BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors.

• DOI: 10.1200/jco.2024.42.16_suppl.2610
• Publication Date: 2024-06-14T20:17:08Z
• Authors: Yufei Liu; Zhisong He; Mingjun Zhang; Shusuan Jiang; Dahong Zhang; Miao Feng; Shenhong Qu; Wutong Ju; Ke Wang; Ramil Abdrashitov; Jifeng Feng
• Keywords: Lenvatinib; Open label

2610 Background: Tislelizumab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, has demonstrated promising efficacy in several advanced solid tumors. However, some patients (pts) do not respond or develop resistance to tislelizumab monotherapy. Lenvatinib, a receptor tyrosine kinase inhibitor targeting VEGFR 1-3, FGFR 1-4, PDGFR alpha, KIT, and RET, shown potential synergistic effect with anti-PD-1 therapy. Here, we report the primary results of phase II study evaluating combination plus lenvatinib pts tumors (NCT05014828). Methods: Pts histologically/cytologically confirmed selected tumors, naïve death-ligand (PD-L1)/PD-1 therapies were enrolled. Part (safety run-in) determined recommended dose (RP2D) 400 mg IV every 6 weeks. In 2 (expansion), received at RP2D from (20 orally/day) per regimen until disease progression, withdrawal, death. The endpoints safety determination (Part 1) overall response rate (ORR; 2). Results: At data cutoff (Oct 20, 2023; median follow-up 12.1 months [mo; renal carcinoma, RCC]; 10.8 mo [head neck squamous HNSCC]; 14.8 [gastric cancer, GC], 22.0 [non-small lung NSCLC]), 58 treated (RCC, n=23; HNSCC, n=27; GC, n=3; NSCLC, n=5), whom also included 1. ORR was 66.7% RCC, 33.3% (HNSCC), (GC), 20.0% (NSCLC). Median duration (mDoR) 18.5 9.6 NSCLC respectively; estimable (NE) for RCC GC (Table). No new signals identified; grade ≥3 treatment-related adverse events reported 78.3%, 59.3%, 60.0%, respectively Conclusions: Tislelizumab had manageable profile showed preliminary antitumor activity tumor types. Longer is needed further investigate this benefit Clinical trial information: NCT05014828 .[Table: see text]