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

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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 , Étienne 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 ·

YOU? · · 2024 · Open Access · · DOI: https://doi.org/10.1200/jco.24.00733

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, 0.75 [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.

Related Topics

Medicine

Lung Cancer

Oncology

Randomized Controlled Trial

Internal Medicine

Cancer

Chemotherapy

Concepts

Medicine Docetaxel Open label Lung cancer Oncology Randomized controlled trial Internal medicine Phases of clinical research Cancer Chemotherapy

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Type: article
Language: en
Landing Page: https://doi.org/10.1200/jco.24.00733
OA Status: green
Cited By: 66
References: 27
Related Works: 10
OpenAlex ID: https://openalex.org/W4399218268

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OpenAlex ID: https://openalex.org/W4399218268

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DOI: https://doi.org/10.1200/jco.24.00733

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

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Language: en

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Publication year: 2024

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Publication date: 2024-05-31

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Authors: 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, Étienne 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

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Concepts: Medicine, Docetaxel, Open label, Lung cancer, Oncology, Randomized controlled trial, Internal medicine, Phases of clinical research, Cancer, Chemotherapy

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Cited by: 66

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Citations by year (recent): 2025: 50, 2024: 16

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