Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.

• DOI: 10.1200/jco.2024.42.17_suppl.lba8500
• Publication Date: 2024-06-05T13:28:57Z
• Authors: Luis G. Paz-Ares; Oscar Juan-Vidal; Giannis Socrates ...; Enriqueta Felip; Niels Reinmuth; Filippo de Marinis; Nicolas Girard; Vipul M. Patel; Takayuki Takahama; Scott Peter Owen; Douglas Reznick; Firas Benyamine B...; Irfan Cicin; Sabeen Fatima Mekan; Riddhi Patel; Eric Zhang; Divyadeep Karumanchi; Marina Chiara Gar...
• Keywords: Clinical endpoint; Progression-free survival

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