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

作者：Luis Paz‐Ares, Óscar Juan, Giannis Mountzios, Enriqueta Felip, Niels Reinmuth, Filippo de Marinis, Nicolas Girard, Vipul M. Patel, Takayuki Takahama, Scott Owen, Douglas Reznick, Firas Badin, İrfan Çiçin, Sabeen Mekan, Riddhi Patel, Éric Zhang, Divyadeep Karumanchi, Marina Chiara Garassino, Elizabeth Ahern, Venessa Chin, Stephen Della‐Fiorentina, Kevin Jasas, Christos S. Karapetis, Jeremy Long, Louise Nott, Kenneth J. O’Byrne, Craig Underhill, Richard Greil, Maximilian J. Hochmair, Andreas Pircher, Wim Demey, Paul Germonpré, Elke Govaerts, Thierry Pieters, Reinier Wener, Alan A. Azambuja, Giuliano Santos Borges, Gilberto de Castro, Suellen Castro, Felipe Melo Cruz, Fábio Franke, Eduardo Silva, Parneet Cheema, Robert H. El-Maraghi, Swati Kulkarni, Rami Nassabein, Scott Owen, Clarisse Audigier-Valette, Jaafar Bennouna, C. Chouaïd, Alexis B. Cortot, S. Couraud, D. Debieuvre, Fabrice Denis, Patrick Dumont, Radj Gervais, Nicolas Girard, Etienne Giroux‐Leprieur, Florian Guisier, Sandrine Hiret, Henri Janicot, Corinne Lamour, J. Madelaine, M. Marcq, E. Pluquet, Jean Louis Pujol, Magali Ravoire, Marielle Sabatini, A. Vergnenègre, Sabine Bohnet, Martin Faehling, Melanie Janning, Eckart Laack, Niels Reinmuth, Achim Rittmeyer, Claas Wesseler, Sofia Baka, George Fountzilas, Panagiotis Katsaounis, Αthanasios Kotsakis, Ioannis Mountzios, Konstantinos Syrigos, Julia Dudnik, Fink Carmel, Ofer Merimsky, Hovav Nechushtan, Julia Sobolev, Franceso Agustoni, Anna Bettini, Matteo Brighenti, Giulio Cerea, Filippo de Marinis, Salvatore Grisanti, Francesco Grossi, Andrea Luciani, Evaristo Maiello, Héctor Soto Parrà, Pierfrancesco Tassone, Giuseppe Tonini, Yoko Agemi, Koichi Azuma, Tomohisa Baba, Yuka Fujita, Eiki Ichihara, Takashi Kasai, Terufumi Kato, Haruki Kobayashi, Shoichi Kuyama, Kazumi Nishino, Masahide Oki, Kyoichi Okishio, Tomohiro Sakamoto, Yuki Sato, Yuki Shinno, Takayuki Takahama, Koichi Takayama, Yasutaka Watanabe, Noriko Yanagitani, Yoshitaka Zenke, Daniel Kuba, Tomas Daniel Pineda Razo, Robin Cornelissen, Lizza Hendriks, Jeroen S. Kloover, Klaar Maas, Cor van der Leest, Lubomir Bodnar, Bogusława Karaszewska, Andrzej Mruk, Paula Alves, António Araújo, Isabel Domingues, Ana da Conceicao Fernandes Rodrigues, Nuno Gil, Helena Magalhães, Bárbara Parente, Márcia Mara Corrêa, Hector A. Velez-Cortes, Andres Aguilar Hernandez, Ruben Alonso Calderon, Joaquim Bosch Barrera, David Vicente Baz, Antonio Calles, Maria Campelo, F.J. de Castro Carpeño, Enric Costa, Manuel Dols, M. Dómine Gómez, Miguel F. Sanmamed, E. Felip Font, José Fuentes, Maria Pilar Garrido Lopez, Óscar Juan, J.L. González-Larriba, Laia Martínez, Ramon Palmero Sanchez, Silverio Ros, Jon Zugazagoitia Fraile, Ahmet Bılıcı, İrfan Çiçin, Umut Demırcı, Yeşim Eralp, Mahmut Gümüş, Ozan Yazıcı, Shobhit Baijal, K. Clarke, Farah Louise Lim, D. Muthukumar, Nicola Steele, Yvonne Summers, Ahmed Abdelaziz, Eric J. Avery, Firas Badin, Charles Connor, Davey B. Daniel, Amir Faridi, January Fields-Meehan, Marina Chiara Garassino, Todd Gersten, Daniel Haggstrom, David Hakimian, William Houck, Henrik Illum, Roger Keresztes, Charles Kurkul, Charles Kuzma, Rachel E. Lerner, Steven Liu, Smitha Menon, Rami Owera, Vipul Patel, Ivor Percent, Andrew J. Piper-Valillo, Sucharu Prakash, Douglas Reznick, Jorge Arturo Rios-Perez, Jun Sun, Restituto Tibayan, Anne M. Traynor, William D. Walsh, Donald B. Wender · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.24.00733 · 被引用次数：126 · 研究领域：Lung Cancer Treatments and Mutations、Cancer Immunotherapy and Biomarkers、Lung Cancer Research Studies

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/m 2 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....