Author(s): Luis G. Paz-Ares, MD, PhD1; Oscar Juan-Vidal, MD2; Giannis S. Mountzios, MD, PhD3; Enriqueta Felip, MD, PhD4; Niels Reinmuth, MD5; Filippo de Marinis, MD, PhD6; Nicolas Girard, MD, PhD7; Vipul M. Patel, MD8; Takayuki Takahama, MD, PhD9; Scott P. Owen, MD10; Douglas M. Reznick, MD11; Firas B. Badin, MD12; Irfan Cicin, MD13; Sabeen Mekan, MD14; Riddhi Patel, PharmD14; Eric Zhang, PhD14; Divyadeep Karumanchi, PharmD14; Marina Chiara Garassino, MD15
PURPOSE
The open-label, phase III EVOKE-01 study evaluated sacituzumab govitecan (SG) versus standard-of-care docetaxel in metastatic non–small cell lung cancer (mNSCLC) with progression on/after platinum-based chemotherapy, anti–PD-(L)1, and targeted treatment for actionable genomic alterations (AGAs). Primary analysis is reported.
METHODS
Patients were randomly assigned 1:1 (stratified by histology, best response to last anti–PD-(L)1–containing regimen, and AGA treatment received or not) to SG (one 10 mg/kg intravenous infusion on days 1 and 8) or docetaxel (one 75 mg/m2 intravenous infusion on day 1) in 21-day cycles. Primary end point was overall survival (OS). Key secondary end points were investigator-assessed progression-free survival (PFS), objective response rate, patient-reported symptom assessment, and safety.
RESULTS
In the intention-to-treat population (SG, n = 299; docetaxel, n = 304), 55.4% had one previous line of therapy. Median follow-up was 12.7 months (range, 6.0-24.0). The primary end point was not met. There was a numerical OS improvement for SG versus docetaxel (median, 11.1 v 9.8 months; hazard ratio [HR], 0.84 [95% CI, 0.68 to 1.04]; one-sided P = .0534), consistent across squamous and nonsquamous histologies. Median PFS was 4.1 versus 3.9 months (HR, 0.92 [95% CI, 0.77 to 1.11]). An OS benefit was observed for SG (n = 192) versus docetaxel (n = 191) in mNSCLC nonresponsive to last anti–PD-(L)1–containing regimen (3.5-month median OS increase; HR, 0.75 [95% CI, 0.58 to 0.97]); this was consistent across histologies. Among patients receiving SG and docetaxel, 6.8% and 14.2% discontinued because of treatment-related adverse events (TRAEs), respectively; 1.4% and 1.0%, respectively, had TRAEs leading to death.
CONCLUSION
Although statistical significance was not met, OS numerically improved with SG versus docetaxel, which was consistent across histologies. Clinically meaningful improvement in OS was noted in mNSCLC nonresponsive to last anti–PD-(L)1–containing regimen. SG was better tolerated than docetaxel and consistent with its known safety profile, with no new safety signals.
Author Affiliations
1Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Complutense University and Ciberonc, Madrid, Spain; 2Hospital Universitari i Politécnic La Fe de Valencia, Valencia, Spain; 3Henry Dunant Hospital Center, Athens, Greece; 4Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain; 5Asklepios Lung Clinic, German Center for Lung Research (DZL), Munich-Gauting, Germany; 6European Institute of Oncology IRCCS, Milan, Italy; 7Institut du Thorax Curie Montsouris, Institut Curie, Paris, France; 8Florida Cancer Specialists and Research Institute, Ocala, FL; 9Kindai University, Osaka, Japan; 10McGill University Health Centre, Montreal, QC, Canada; 11Rocky Mountain Cancer Center, Aurora, CO; 12Baptist Health Medical Group, Lexington, KY; 13Istinye University, Medical Center, Istanbul, Turkey; 14Gilead Sciences, Inc, Foster City, CA; 15University of Chicago Comprehensive Cancer Center, Chicago, IL
