Abstract
LBA8500 Background: In pts with mNSCLC who progress on PT-based chemo and IO, doc is standard of care, but outcomes remain poor. SG, a Trop-2-directed antibody drug conjugate, showed durable response and tolerable safety in pretreated mNSCLC. We report results from the phase 3, randomized, open-label EVOKE-01 study comparing SG vs doc. Methods: Pts with mNSCLC with disease progression after PT-based chemo and IO were randomized 1:1 (stratified by histology, best response to last prior IO, and prior treatment for actionable genomic alterations [yes/no]) to receive SG (10 mg/kg IV, days 1 and 8) or doc (75 mg/m2 IV, day 1) in 21-day cycles until progression or unacceptable toxicity. The primary endpoint was overall survival (OS); key secondary endpoints were investigator assessed progression-free survival (PFS) and objective response rate (ORR), patient-reported outcomes (PROs), and safety. Results: As of Nov 29, 2023, 603 pts were randomized. Median (range) age was 65 (31–84) yrs; 55% had 1 prior therapy line. The study was not statistically significant for OS. A numerical improvement in OS, favoring SG, was seen (HR 0.84 [95% CI, 0.68–1.04; 1-sided P = 0.0534]) including in pts with squamous and nonsquamous histology. PFS and ORR are shown in the Table. A clinically meaningful difference in median OS favoring SG (3.5 mo) was seen in pts without response to last prior IO. PROs were improved with SG vs doc. Grade ≥3 treatment-emergent adverse event (TEAE) incidence was 66.6% (SG) and 75.7% (doc). Treatment-related AEs led to discontinuation in 6.8% (SG) and 14.2% (doc). Conclusions: Although statistical significance was not met, SG showed numerical improvement in OS vs doc. Results were consistent across all major subgroups including histology. Clinically meaningful improvement in OS was noted in pts without response to prior IO. SG was better tolerated than doc; observed safety was consistent with the known profile. Clinical trial information: NCT05089734 . [Table: see text]
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