PURPOSE: 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). PATIENTS AND METHODS: 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. RESULTS: 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 patients (18.2%). CONCLUSIONS: SG plus pembrolizumab and carboplatin had activity in mNSCLC. When combined with pembrolizumab and carboplatin, SG was tolerated at a dose of 7.5 mg/kg.
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