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Sacituzumab Tirumotecan With Keytruda Improves Progression-Free Survival in China Phase 3 Lung Cancer Trial

Company-reported results show higher tumor response alongside increased serious blood-related adverse events, a mix that will shape regulatory review and further development.

Merck and Keytruda logos are seen in this illustration taken March 26, 2025. REUTERS/Dado Ruvic/Illustration/File Photo

Overview

  • Sichuan Kelun-Biotech reported that a late-stage China trial of sacituzumab tirumotecan plus Merck’s Keytruda met its primary endpoint by significantly improving progression-free survival compared with Keytruda alone.
  • The company said the combination raised objective response rates to about 70% versus about 42% for Keytruda alone in more than 400 previously untreated patients with advanced non-small cell lung cancer.
  • Safety findings were consistent with known drug profiles but serious adverse events were more frequent in the combination arm, most notably low white blood cell counts (neutropenia) and anemia.
  • The study tested the antibody-drug conjugate sac-TMT, which targets the TROP2 protein to deliver chemotherapy directly to tumor cells, as first-line therapy in patients selected for PD-L1 expression.
  • These are company-announced, preliminary results that will need longer follow-up for overall survival data and formal regulatory review before the regimen could change standards of care or patient access.