Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study

作者：Myung‐Ju Ahn, Kentaro Tanaka, Luis Paz‐Ares, Robin Cornelissen, Nicolas Girard, Elvire Pons‐Tostivint, David Vicente Baz, Shunichi Sugawara, Manuel Cobo, M. Pérol, Céline Mascaux, Elena Poddubskaya, Satoru Kitazono, Hidetoshi Hayashi, Min Hee Hong, Enriqueta Felip, Richard D. Hall, Óscar Juan, Daniel Brungs, Shun Lü, Marina Chiara Garassino, Michael Chargualaf, Yong Zhang, Paul Howarth, Deise Uema, Aaron Lisberg, Jacob Sands, for the TROPION-Lung01 Trial Investigators, Gastón Lucas Martinengo, Juan Puig, Daniel Brungs, Bo Gao, Adnan Nagria, Christos S. Karapetis, Sagun Parakh, Cheol Park, Gaëtan Catala, Frédéric Forget, Sebahat Ocak, Naveen S. Basappa, Geoffrey Liu, Ines B. Menjak, Benjamin Shieh, Shun Lü, Feng Luo, Hongmei Sun, Jialei Wang, Yu Yao, Milada Zemanová, Jaafar Bennouna, Nicolas Girard, Laurent Greillier, Corinne Lamour, H. Léna, Céline Mascaux, Julien Mazières, Denis Moro‐Sibilot, M. Pérol, Elvire Pons‐Tostivint, Virginie Westeel, Akin Atmaca, Christine Greil, Niels Reinmuth, Christian Schumann, Thomas Wehler, Juergen Wolf, James Ho, Csaba Böcskei, Federico Cappuzzo, Filippo de Marinis, Claudia Proto, Manlio Mencoboni, Silvia Novello, Stefania Salvagni, Héctor Soto Parrà, Haruko Daga, Yasushi Goto, Hidetoshi Hayashi, Satoru Kitazono, Kiyotaka Yoh, Ryo Ko, Masashi Kondo, Toshiyuki Kozuki, Takayasu Kurata, Hideaki Mizutani, Kadoaki Ohashi, Satoshi Oizumi, Isamu Okamoto, Satoshi Sakaguchi, H Ozasa, Shunichi Sugawara, Yuichi Tambo, Motohiro Tamiya, Hiroshi Tanaka, Isamu Okamoto, Froylán López-López, Francisco Javier Ramírez Godinez, Jerónimo Rafael Rodríguez Cid, Robin Cornelissen, Steven Gans, Jos A. Stigt, Dariusz M. Kowalski, Anna Łowczak, Janusz Milanowski, Robert Mróz, Rodryg Ramlau, Mirelis Acosta-Rivera, Myung-Ju Ahn, Yee Soo Chae, Min Hee Hong, Jin-Hyoung Kang, Sang‐We Kim, Jin Soo Kim, Se Hyun Kim, Ki Hyeong Lee, Yun Gyoo Lee, Byoung Yong Shim, Е. V. Ledin, Elena Poddubskaya, Boon Yeow Daniel Chan, Amit Jain, Chee‐Seng Tan, Maria Carmen Areses, Manuel Cobo, Manuel Dómine, Enriqueta Felip, José Fuentes Pradera, Dolores Isla, Óscar Juan, Margarita Majem, Luis Paz‐Ares, Mariano Provencio, Noemı́ Reguart, David Vicente Baz, Ferdinando Cerciello, Martin Früh, W.C. Chang, Gee-Chen Chang, Wen-Tsung Huang, Chien-Chung Ling, Yu‐Feng Wei, Tsung‐Ying Yang, Tanya Ahmad, Fabio M. Gomes, T. Mansy, Débora S. Bruno, Michael Castine, Bruno Fang, Marina Chiara Garassino, Richard D. Hall, Balázs Halmos, Khawaja Jahangir, Melissa L. Johnson, Tirrell Johnson, Sujith Kalmadi, William Lawler, Aaron Lisberg, Ahad A. Sadiq, Jacob Sands, Benjamin Solomon, Andrea Veatch · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco-24-01544 · 被引用次数：211 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Research Studies、Lung Cancer Diagnosis and Treatment

PURPOSE The randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non–small cell lung cancer (NSCLC). METHODS Patients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m 2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points. RESULTS In total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade ≥3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis o...