First-line sacituzumab govitecan plus pembrolizumab and carboplatin in nonsquamous and squamous mNSCLC

EVOKE-02 is a multinational, multicohort phase 2 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). Results from the nonsquamous and squamous cohorts have now been published. Adults with mNSCLC, no prior systemic treatment, and no actionable genomic alterations received SG 10 mg/kg (due to myelosuppression reduced to 7.5 mg/kg following a preplanned safety evaluation) on days 1 and 8, plus pembrolizumab 200 mg on day 1 and carboplatin AUC 5 on day 1 in 21-day cycles. The primary endpoint was objective response rate (ORR) per independent review committee. A total of 54 and 41 patients had nonsquamous and squamous histology, respectively. ORR was 45.1% (95% CI 3.1-59.7) for nonsquamous and 39.0% (24.2-55.5) for squamous histology. ORR was 66.7% (95% CI 34.9-90.1) for PD-L1 tumor proportion score ≥ 50%. The median progression-free survival was 8.1 months (95% CI 5.2-15.0) for nonsquamous and 8.3 months (4.3-11.2) for squamous histology. Grade ≥ 3 TEAEs ocurred in 86.4%; TEAEs leading to discontinuation of any study drug occurred in 18.2%. The authors conclude that SG plus pembrolizumab and carboplatin had activity in mNSCLC. SG in this combination was tolerated at a dose of 7.5 mg/kg.