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Record W4399218268 · doi:10.1200/jco.24.00733

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

2024· article· en· W4399218268 on OpenAlexaff
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, Clarisse Audigier-Valette, Jaafar Bennouna, C. Chouaïd, Alexis B. Cortot, S. Couraud, D. Debieuvre, Fabrice Denis, Patrick Dumont, Radj Gervais, 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, 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, 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, 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, Manuel Cobo, M. Dómine Gómez, Miguel F. Sanmamed, E. Felip Font, José Fuentes, J.L. González-Larriba, Laia Martínez, Silverio Ros, Jon Zugazagoitia Fraile, Ahmet Bılıcı, 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, Charles Connor, Davey B. Daniel, Amir Faridi, January Fields-Meehan, 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, Jorge Arturo Rios-Perez, Jun Sun, Restituto Tibayan, Anne M. Traynor, William D. Walsh, Donald B. Wender

Bibliographic record

VenueJournal of Clinical Oncology · 2024
Typearticle
Languageen
FieldMedicine
TopicLung Cancer Treatments and Mutations
Canadian institutionsMcGill University Health Centre
FundersCentro de Investigación Biomédica en Red de CáncerEuropean CommissionNational Institute on Minority Health and Health DisparitiesComunidad de MadridInstituto de Salud Carlos IIIGilead Sciences
KeywordsMedicineDocetaxelOpen labelLung cancerOncologyRandomized controlled trialInternal medicinePhases of clinical researchCancerChemotherapy

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.004
metaresearch head score (Gemma)0.002
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.257
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0030.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.154
GPT teacher head0.563
Teacher spread0.409 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations115
Published2024
Admission routes1
Has abstractyes

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