Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study

被引:20
|
作者
Paz-Ares, Luis G. [1 ,2 ]
Juan-Vidal, Oscar [3 ]
Mountzios, Giannis S. [4 ]
Felip, Enriqueta [5 ,6 ]
Reinmuth, Niels [7 ]
de Marinis, Filippo [8 ]
Girard, Nicolas [9 ]
Patel, Vipul M. [10 ]
Takahama, Takayuki [11 ]
Owen, Scott P. [12 ]
Reznick, Douglas M. [13 ]
Badin, Firas B. [14 ]
Cicin, Irfan [15 ]
Mekan, Sabeen [16 ]
Patel, Riddhi [16 ]
Zhang, Eric [16 ]
Karumanchi, Divyadeep [16 ]
Garassino, Marina Chiara [17 ]
机构
[1] Univ Complutense, Hosp Univ 12 Octubre, H120 CNIO Lung Canc Unit, Madrid, Spain
[2] Ciberonc, Madrid, Spain
[3] Hosp Univ & Politecn La Fe Valencia, Valencia, Spain
[4] Henry Dunant Hosp Ctr, Athens, Greece
[5] Vall Hebron Univ Hosp, Barcelona, Spain
[6] Vall Hebron Inst Oncol, Barcelona, Spain
[7] German Ctr Lung Res DZL, Asklepios Lung Clin, Munich, Germany
[8] European Inst Oncol IRCCS, Milan, Italy
[9] Inst Thorax Curie Montsouris, Inst Curie, Paris, France
[10] Florida Canc Specialists & Res Inst, Ocala, FL USA
[11] Kindai Univ, Osaka, Japan
[12] McGill Univ Hlth Ctr, Montreal, PQ, Canada
[13] Rocky Mt Canc Ctr, Aurora, CO USA
[14] Baptist Hlth Med Grp, Lexington, KY USA
[15] Istinye Univ, Med Ctr, Istanbul, Turkiye
[16] Gilead Sci Inc, Foster City, CA USA
[17] Univ Chicago, Comprehens Canc Ctr, Chicago, IL USA
关键词
ANTIBODY-DRUG CONJUGATE; PEMBROLIZUMAB; EFFICACY; SAFETY; 2ND;
D O I
10.1200/JCO.24.00733
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSEThe 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.METHODSPatients 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.RESULTSIn 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.CONCLUSIONAlthough 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.
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页数:17
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