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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Thursday, June 6, 2024
The EVOKE-01 study, performed by Luis G. Paz-Ares, MD, PhD, of Hospital Universitario 12 de Octubre, Madrid, and colleagues, compared the use of sacituzumab govitecan-hziy with docetaxel in patients with previously treated, metastatic non–small cell lung cancer (NSCLC). The primary results of this study, which suggest the antibody-drug conjugate was well tolerated with a consistent safety profile, were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8500).
“Although statistical significance was not met, sacituzumab govitecan-hziy showed numerical improvement in overall survival vs docetaxel,” concluded the investigators. “Clinically meaningful improvement in overall survival was noted in patients without response to prior PD-L1 inhibitors.”
This phase III study enrolled 603 patients with metastatic NSCLC whose disease progressed after treatment with platinum-based chemotherapy and PD-L1 inhibitors (ClinicalTrials.gov identifier NCT05089734). Participants were randomly assigned 1:1 to receive 10 mg/kg of sacituzumab govitecan (n = 299) or 75 mg/m2 of docetaxel (n = 304) for up to 21 cycles or until unacceptable toxicity or disease progression.
The median patient age was 65, and 55% of patients had received one prior therapy line. There was a numerical improvement in overall survival, which favored sacituzumab govitecan over docetaxel (11.1 vs 9.8 months); this remained true regardless of histology, according to the study authors. Progression-free survival was also slightly increased among patients receiving sacituzumab govitecan (4.1 months) vs docetaxel (3.9 months).
Among patients who did not experience a response to their last prior immunotherapy, sacituzumab govitecan demonstrated a clinically meaningful improvement in overall survival compared with docetaxel (11.8 vs 8.3 months). Patient-reported outcomes were also improved with sacituzumab govitecan. The incidence of grade 3 or higher treatment-related adverse events was lower with sacituzumab govitecan (66.6%) compared with docetaxel (75.7%), as was treatment discontinuation (6.8% vs 14.2%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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