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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dc.authorscopusidİrfan Çiçin / 8922379100
dc.authorwosidİrfan Çiçin / JQU-1347-2023
dc.contributor.authorPaz-Ares, Luis G.
dc.contributor.authorJuan-Vidal, Oscar
dc.contributor.authorMountzios, Giannis S.
dc.contributor.authorFelip, Enriqueta
dc.contributor.authorÇiçin, İrfan
dc.date.accessioned2025-04-18T10:24:07Z
dc.date.available2025-04-18T10:24:07Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractPURPOSEThe 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.METHODSPatients 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.RESULTSIn 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.CONCLUSIONAlthough 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.
dc.identifier.citationJuan-Vidal, O., Mountzios, G., Reinmuth, N., de Marinis, F., Paz-Ares, L., & FELIP, E. (2024, August). Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. American Society of Clinical Oncology.
dc.identifier.doi10.1200/JCO.24.00733
dc.identifier.endpage2872
dc.identifier.issn0732183X
dc.identifier.issue24
dc.identifier.pmid38843511
dc.identifier.scopus2-s2.0-85201455701
dc.identifier.scopusqualityQ1
dc.identifier.startpage2860
dc.identifier.urihttp://dx.doi.org/10.1200/JCO.24.00733
dc.identifier.urihttps://hdl.handle.net/20.500.12713/7049
dc.identifier.volume42
dc.identifier.wosWOS:001291914000009
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorÇiçin, İrfan
dc.institutionauthoridİrfan Çiçin / 0000-0002-7584-3868
dc.language.isoen
dc.publisherLippincott williams and wilkins
dc.relation.ispartofJournal of clinical oncology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleSacituzumab govitecan versus docetaxel for previously treated advanced or metastatic non-small cell lung cancer: the randomized, open-label phase III EVOKE-01 study
dc.typeArticle

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