Data from First-Line Sacituzumab Govitecan Plus Pembrolizumab and Carboplatin in Metastatic Non–Small Cell Lung Cancer: Nonsquamous and Squamous Cohorts of the EVOKE-02 Study
作者:Jhanelle E. Gray, Joel W. Neal, Jyoti D. Patel, Stephen V. Liu, Rémi Veillon, Martin Reck, Federico Cappuzzo, Manuel Cobo, Noemı́ Reguart, José Fuentes, Byoung Chul Cho, Tony Mok, Sabeen Mekan, Farnoush Safavi, Nelumka Fernando, Michael Chisamore, Edward B. Garon · 年份:2026 · DOI:10.1158/1078-0432.c.8600814 · 研究领域:Medicine、Internal medicine、Oncology
<div>AbstractPurpose:<p>EVOKE-02 (NCT05186974) is a multicohort, phase II trial evaluating first-line sacituzumab govitecan (SG) plus pembrolizumab with or without platinum-based chemotherapy in patients with metastatic non–small cell lung cancer (mNSCLC).</p>Patients and Methods:<p>Adults with mNSCLC, no prior systemic treatment, and no actionable genomic alterations received SG 10 mg/kg intravenously (reduced to 7.5 mg/kg following a preplanned safety evaluation) on days 1 and 8, plus pembrolizumab 200 mg intravenously on day 1 and carboplatin area under the curve 5 on day 1 in 21-day cycles. The primary endpoint was objective response rate (ORR) per independent review committee; secondary endpoints included progression-free survival (PFS) and safety.</p>Results:<p>As of June 3, 2024, 54 and 41 patients had nonsquamous and squamous histology, respectively. ORR (95% confidence interval [CI]) was 45.1% (3.1–59.7) for nonsquamous and 39.0% (24.2–55.5) for squamous histology. Median (95% CI) PFS was 8.1 (5.2–15.0) months for nonsquamous and 8.3 (4.3–11.2) months for squamous histology. ORR (95% CI) was 66.7% (34.9–90.1) for programmed cell death-ligand 1 tumor proportion score greater than or equal to 50%. SG dose was adjusted to 7.5 mg/kg due to myelosuppression. Grade greater than or equal to 3 treatment-emergent adverse events (TEAEs) occurred in 57 patients (86.4%). TEAEs leading to discontinuation of any study drug occurred in 12 patient...