Abstract CT067: Pembrolizumab with and without sacituzumab govitecan as first-line treatment for metastatic non-small-cell lung cancer (NSCLC) with PD-L1 TPS ≥50%: phase 3 KEYNOTE-D46/EVOKE-03 study

作者：Mor Moskovitz, Isamu Okamoto, Peng Chen, Jilpa Patel, Sabeen Mekan, M. Catherine Pietanza, Yalin Zhu, Renata Eiras, Marcello Tiseo · 发表于：Cancer Research · 年份：2023 · DOI：10.1158/1538-7445.am2023-ct067 · 被引用次数：4 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Research Studies、Esophageal Cancer Research and Treatment

Abstract Background: Sacituzumab govitecan is an antibody-drug conjugate comprising an anti-trophoblast cell-surface antigen 2 (Trop-2) antibody coupled to a potent payload, SN-38, via a proprietary, hydrolysable linker. In heavily pretreated patients with metastatic NSCLC, sacituzumab govitecan showed a durable antitumor response and was well tolerated with a 10-mg/kg dose regimen. Monotherapy with the anti-PD-1 monoclonal antibody pembrolizumab is a standard-of-care therapy for patients with previously untreated advanced/metastatic NSCLC with no sensitizing EGFR or ALK alterations and a PD-L1 tumor proportion score (TPS) ≥50%. KEYNOTE-D46 evaluates whether adding sacituzumab govitecan to pembrolizumab monotherapy can improve outcomes in patients with metastatic NSCLC with PD-L1 TPS ≥50%. Trial Design: In this phase 3, open-label, active comparator-controlled, randomized study, ~614 eligible adults with previously untreated metastatic NSCLC; no EGFR, ALK, or ROS1 alterations; PD-L1 TPS ≥50%; and measurable disease per RECIST version 1.1 will be randomized 1:1 to receive either pembrolizumab 200 mg Q3W for up to 35 cycles plus sacituzumab govitecan 10 mg/kg on days 1 and 8 of each Q3W cycle (no maximum treatment duration) or pembrolizumab 200 mg Q3W for up to 35 cycles. Randomization is stratified by ECOG PS (0 vs 1), histology (squamous vs nonsquamous), and geographic region (East Asia vs North America/Western Europe/Australia vs Rest of World). Treatment continues until PD,...