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

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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.

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