Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025
First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Reck Martin, Patel Jyoti D, Gray Jhanelle E, Reguart Noemí, Cobo Manuel, Pradera José Fuentes, Felip Enriqueta, Cappuzzo Federico, Garon Edward B, Neal Joel W, Mekan Sabeen, Safavi Farnoush, Fernando Nelumka, Zavodovskaya Marianna, Jürgensmeier Juliane M, Chisamore Michael, Cho Byoung Chul
Аннотация
INTRODUCTION: Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate previously studied in patients with pretreated metastatic NSCLC (mNSCLC). Here, we report the results of EVOKE-02 (NCT05186974), a global, open-label, multicohort phase 2 study of SG plus pembrolizumab as first-line treatment in patients with mNSCLC.
METHODS: Adult patients without prior systemic mNSCLC treatment, and no actionable genomic alterations, received SG 10 mg/kg intravenously on days 1 and 8 plus pembrolizumab 200 mg intravenously on day 1 of 21-day cycles. The primary end point was objective response rate (ORR) per independent review committee, and secondary end points included progression-free survival (PFS) and safety.
RESULTS: As of data cutoff (June 3, 2024), there were 30 patients with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) more than or equal to 50% (cohort A) and 62 patients with PD-L1 TPS less than 50% (cohort B). ORR (95% confidence interval) was 66.7% (47.2-82.7) for cohort A and 29.0% (18.2-41.9) for cohort B. Median (95% confidence interval) PFS was 13.1 (6.7-not reached) months for cohort A and 7.0 (4.2-12.9) months for cohort B. Trop-2 expression did not correlate with greater clinical efficacy (PFS, ORR) from treatment with SG plus pembrolizumab. Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 70 patients (76.1%); the most common TEAE was neutropenia (17.4%). TEAEs leading to discontinuation of any study drug occurred in 25 patients (27.2%).
CONCLUSIONS: SG plus pembrolizumab demonstrated activity as treatment for mNSCLC, especially in patients with PD-L1 TPS more than or equal to 50%. AEs were manageable and consistent with the known safety profile of each individual agent.
METHODS: Adult patients without prior systemic mNSCLC treatment, and no actionable genomic alterations, received SG 10 mg/kg intravenously on days 1 and 8 plus pembrolizumab 200 mg intravenously on day 1 of 21-day cycles. The primary end point was objective response rate (ORR) per independent review committee, and secondary end points included progression-free survival (PFS) and safety.
RESULTS: As of data cutoff (June 3, 2024), there were 30 patients with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) more than or equal to 50% (cohort A) and 62 patients with PD-L1 TPS less than 50% (cohort B). ORR (95% confidence interval) was 66.7% (47.2-82.7) for cohort A and 29.0% (18.2-41.9) for cohort B. Median (95% confidence interval) PFS was 13.1 (6.7-not reached) months for cohort A and 7.0 (4.2-12.9) months for cohort B. Trop-2 expression did not correlate with greater clinical efficacy (PFS, ORR) from treatment with SG plus pembrolizumab. Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 70 patients (76.1%); the most common TEAE was neutropenia (17.4%). TEAEs leading to discontinuation of any study drug occurred in 25 patients (27.2%).
CONCLUSIONS: SG plus pembrolizumab demonstrated activity as treatment for mNSCLC, especially in patients with PD-L1 TPS more than or equal to 50%. AEs were manageable and consistent with the known safety profile of each individual agent.