Dr Zhang on Sacituzumab Tirumotecan in Pretreated Advanced EGFR-Mutated NSCLC

“The ORR in the sacituzumab tirumotecan group was significantly higher compared with docetaxel at 45.1% vs 15.6%, [respectively].”

Li Zhang, MD, deputy director of the Lung Cancer Research Center and professor in the Medical Oncology Department at Sun Yat-sen University Cancer Center, discussed efficacy data from the phase 2 OptiTROP-Lung03 trial (NCT05631262) of sacituzumab tirumotecan in patients with previously treated, advanced EGFR-mutated non–small cell lung cancer (NSCLC).

OptiTROP-Lung03 enrolled patients with nonsquamous NSCLC with an ECOG performance status of 0 or 1 who experienced disease progression following prior combination or sequential treatment with EGFR TKIs and platinum-based chemotherapy. Eligible patients were randomly assigned 2:1 to receive 5 mg/kg of intravenous (IV) sacituzumab tirumotecan every 2 weeks or IV docetaxel at a dose of 75 mg/m² every 3 weeks. The primary end point was overall response rate (ORR) per blinded independent review committee (BIRC); secondary end points included progression-free survival (PFS) and overall survival (OS).

During the 2025 ASCO Annual Meeting, Zhang presented data from OptiTROP-Lung03 that demonstrated that patients who received sacituzumab tirumotecan (n = 91) achieved a confirmed ORR by BIRC of 45.1% (95% CI, 34.6%-55.8%) vs 15.6% (95% CI, 6.5%-29.5%) in the docetaxel arm (n = 45). These values represented a difference in ORR of 28.9% (95% CI, 14.5%-43.2%; 1-sided P = .0004), which was a significant improvement in favor of the investigational arm, Zhang noted. The median PFS by BIRC was 6.9 months (95% CI, 5.4-8.2) in the sacituzumab tirumotecan arm compared with 2.8 months (95% CI, 1.6-4.1) in the docetaxel arm (n = 46), representing an HR of 0.30 (95% CI, 0.20-0.46; P < .0001), which was highly significant, he added.

At a median follow-up of 12.2 months, the median OS adjusted for crossover was not reached (95% CI, not estimable [NE]-NE) in the investigational arm compared with 9.3 months (95% CI, 7.3-NE) in the control arm. The 12-month OS rates were 72.8% and 43.2%, respectively. The HR for OS was 0.36 (95% CI, 0.20-0.66) in favor of the sacituzumab tirumotecan arm, which was highly significant, Zhang concluded.