US EditionThe British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC
- Kelun-Biotech announced results on June 7, 2025, in The British Medical Journal from the OptiTROP-Lung03 trial of sacituzumab tirumotecan for advanced EGFR-mutant NSCLC.
- The phase 2 trial enrolled 137 patients who progressed after EGFR-TKI and platinum chemotherapy, with data cutoff on December 31, 2024, and sac-TMT receiving breakthrough designation in December 2024.
- Sac-TMT showed a confirmed objective response rate of 45.1% versus 15.6% for docetaxel, with median progression-free survival of 6.9 months versus 2.8 months and improved 12-month overall survival rates.
- Li Zhang, lead author, stated at the 2025 ASCO meeting that sac-TMT had a manageable safety profile and demonstrated significant clinical benefits over docetaxel in this population.
- Based on these encouraging data, sac-TMT received marketing approval in China in March 2025 as the first TROP2 ADC approved for lung cancer, suggesting a potential new standard for these patients.
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The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC
CHENGDU, China, June 6, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) today announced that results from its registrational study (OptiTROP-Lung03) evaluating sacituzumab tirumotecan (sac-TMT) versus docetaxel in patients with previously treated advanced EGFR-mutant non-small cell lung cancer…
FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations
FDA Grants Breakthrough Therapy Designation to sac-TMT for Certain Patients With Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations
·Crystal River, United States
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