Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study
Authors: Paz-Ares Luis G. , Juan-Vidal Oscar , Mountzios Giannis S. , Felip Enriqueta , Reinmuth Niels , de Marinis Filippo , Girard Nicolas , Patel Vipul M. , Takahama Takayuki , Owen Scott P. , Reznick Douglas M. , Badin Firas B. , Cicin Irfan , Mekan Sabeen , Patel Riddhi , Zhang Eric , Karumanchi Divyadeep , Garassino Marina Chiara , Ahern Elizabeth , Chin Venessa , Della-Fiorentina Stephen , Jasas Kevin , Karapetis Christos , Long Jeremy , Nott Louise , O'Byrne Kenneth , Underhill Craig , Greil Richard , Hochmair Maximilian , Pircher Andreas , Demey Wim , Germonpré Paul , Govaerts Elke , Pieters Thierry , Wener Reinier , Azambuja Alan , Borges Giuliano , Castro Gilberto , Castro Suellen , Cruz Felipe , Franke Fábio , Silva Eduardo , Cheema Parneet , El-Maraghi Robert , Kulkarni Swati , Nassabein Rami , Owen Scott , Audigier Valette Clarisse , Bennouna Jaafar , Chouaid Christos , Cortot Alexis , Couraud Sebastien , Debieuvre Didier , Denis Fabrice , Dumont Patrick , Gervais Radj , Girard Nicolas , Giroux Leprieur Etienne , Guisier Florian , Hiret Sandrine , Janicot Henri , Lamour Corinne , Madelaine Jeannick , Marcq Marie , Pluquet Emilie , Louis Pujol Jean , Ravoire Magali , Sabatini Marielle , Vergnenegre Alain , Bohnet Sabine , Faehling Martin , Janning Melanie , Laack Eckart , Reinmuth Niels , Rittmeyer Achim , Wesseler Claas , Baka Sofia , Fountzilas George , Katsaounis Panagiotis , Kotsakis Athanasios , Mountzios Ioannis , Syrigos Konstantinos , Dudnik Julia , Carmel Fink , Merimsky Ofer , Nechushtan Hovav , Sobolev Julia , Agustoni Franceso , Cecilia Bettini Anna , Brighenti Matteo , Cerea Giulio , De Marinis Filippo , Grisanti Salvatore , Grossi Francesco , Luciani Andrea , Maiello Evaristo , Soto Parra Hector , Tassone Pierfrancesco , Tonini Giuseppe , Agemi Yoko , Azuma Koichi , Baba Tomohisa , Fujita Yuka , Ichihara Eiki , Kasai Takashi , Kato Terufumi , Kobayashi Haruki , Kuyama Shoichi , Nishino Kazumi , Oki Masahide , Okishio Kyoichi , Sakamoto Tomohiro , Sato Yuki , Shinno Yuki , Takahama Takayuki , Takayama Koichi , Watanabe Yasutaka , Yanagitani Noriko , Zenke Yoshitaka , Motola Kuba Daniel , Daniel Pineda Razo Tomas , Cornelissen Robin , Hendriks Lizza , Kloover Jeroen , Maas Klaar , van der Leest Cor , Bodnar Lubomir , Karaszewska Boguslawa , Mruk Andrzej , Alves Paula , Araujo Antonio , Domingues Isabel , da Conceicao Fernandes Rodrigues Ana , Gil Nuno , Magalhaes Helena , Parente Barbara , Correa Marcia , Velez-Cortes Hector , Aguilar Hernandez Andres , Alonso Calderon Ruben , Barrera Joaquim , Baz David , Calles Antonio , Campelo Maria , Carpeno Francisco , Costa Enric , Dols Manuel , Domine Gomez Manuel , Fernandez de Sanmamed Miguel , Font Enriqueta , Fuentes Jose , Pilar Garrido Lopez Maria , Juan Vidal Oscar , Larriba Jose , Martinez Laia , Palmero Sanchez Ramon , Ros Martinez Silverio , Zugazagoitia Fraile Jon , Bilici Ahmet , Cicin Irfan , Demirci Umut , Eralp Yesim , Gumus Mahmut , Yazici Ozan , Baijal Shobhit , Clarke Katy , Lim Farah , Muthukumar Dakshinamoorthy , Steele Nicola , Summers Yvonne , Abdelaziz Ahmed , Avery Eric , Badin Firas , Connor Charles , Daniel Davey , Faridi Amir , Fields-Meehan January , Garassino Marina , Gersten Todd , Haggstrom Daniel , Hakimian David , Houck William , Illum Henrik , Keresztes Roger , Kurkul Charles , Kuzma Charles , Lerner Rachel , Liu Steven , Menon Smitha , Owera Rami , Patel Vipul , Percent Ivor , Piper Andrew , Prakash Sucharu , Reznick Douglas , Rios-Perez Jorge , Sun Jun , Tibayan Restituto , Traynor Anne , Walsh William , Wender Donald 
Published: May 2024

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.