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

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

Source: https://doi.org/10.1200/JCO.24.0073

Dr. Maen Hussein's Thoughts

Failed? Numerical overall survival (OS) benefit for sacituzumab vs docetaxol, but not statistically significant. Better tolerated, also overall survival (OS) noticed more in patients who did not respond to antiPDL-1 therapy.

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

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