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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Thursday, December 11, 2025
Treatment with the TROP2 antibody-drug conjugate sacituzumab tirumotecan vs platinum-based chemotherapy resulted in significant improvements in progression-free and overall survival in patients with EGFR-mutated non–small cell lung cancer (NSCLC) resistant to EGFR-tyrosine kinase inhibitors, based on results from the multicenter phase III OptiTROP-Lung04 trial. At the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract LBA5), Li Zhang, MD, of Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues also reported a manageable safety profile.
Previously reported findings from part II of the phase II OptiTROP-Lung03 trial showed that sacituzumab tirumotecan provided a significant survival advantage over docetaxel in patients with EGFR-mutated NSCLC whose disease had progressed after EGFR-tyrosine kinase inhibition and platinum-based chemotherapy. The final progression-free survival and preplanned interim overall survival analyses from the present confirmatory study “position [sacituzumab tirumotecan] as a potential new standard of care for this population,” according to the investigators.
A total of 376 patients were randomly assigned in a 1:1 ratio to receive either sacituzumab tirumotecan monotherapy (5 mg/kg) every 2 weeks or platinum-based chemotherapy consisting of pemetrexed (500 mg/m²) plus carboplatin (area under the curve 5) or cisplatin (75 mg/m²) every 3 weeks for four cycles, followed by pemetrexed maintenance therapy. At a median follow-up of 18.9 months, 21.3% and 1.6% of these arms, respectively, remained on treatment.
Sacituzumab tirumotecan vs chemotherapy was found to demonstrate statistically significant and clinically meaningful improvements in progression-free (median, 8.3 vs 4.3 months; hazard ratio [HR] = 0.49; P < .0001) and overall (median, not reached vs 17.4 months; HR = 0.60; P = .0006) survival. The rates of grade 3 or higher (49.5% vs 52.2%) and serious (7.4% vs 17.0%) treatment-related adverse events were lower with sacituzumab tirumotecan than with chemotherapy. No drug-related interstitial lung disease/pneumonitis was reported in either arm.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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