The U.S. Food and Drug Administration (FDA) has granted accelerated approval to datopotamab deruxtecan-dlnk (marketed as Datroway) for the treatment of adults with EGFR-mutated advanced non-small cell lung cancer (NSCLC) who have previously undergone EGFR therapy and platinum-based chemotherapy. This approval marks the first TROP2-directed antibody-drug conjugate (ADC) authorized for this patient population. The decision was based on clinical data demonstrating an objective response rate (ORR) of approximately 45%, a notable improvement compared to historical ORRs of 10-20% in this setting, where standard treatment options are limited following osimertinib and chemotherapy. Additional oncology developments reported include promising efficacy of frontline firmonertinib in EGFR-mutant NSCLC, the combination of fruquintinib with chemotherapy and PD-1 blockade in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma, and the tolerability and activity of THIO plus cemiplimab in advanced NSCLC resistant to immune checkpoint inhibitors. Tivozanib monotherapy showed efficacy as a second-line treatment in metastatic renal cell carcinoma (RCC) after prior immunotherapy or tyrosine kinase inhibitor (TKI) combinations. Other updates include the FDA granting orphan drug designation to a treatment for antibody-mediated rejection and fast track designation to SGR-1505 for relapsed/refractory Waldenström macroglobulinemia. Investigational therapies such as Obrixtamig targeting DLL3 in extrapulmonary neuroendocrine carcinoma, TQB2102 in HER2-low breast cancer, and Zidesamtinib in ROS1-positive NSCLC also demonstrated clinical activity. Additionally, Tango Therapeutics initiated a Phase 1/2 trial combining TNG462 with daraxonrasib or zoldonrasib for RAS-mutant MTAP-deleted pancreatic or lung cancer.
$TNGX Announces First Patient Dosed in Phase 1/2 Trial of TNG462 plus Revolution Medicines’ Daraxonrasib or Zoldonrasib in Patients with RAS-Mutant MTAP-deleted Pancreatic or Lung Cancer A cytoplasmic and chromatin mechanisms combination makes sense. Tango is looking at https://t.co/EKxxt4dKA1
Zidesamtinib Produces Durable Responses in TKI-Pretreated, ROS1+ NSCLC #lcsm #oncology https://t.co/jWBonhjgRq
TQB2102 Generates Antitumor Activity in Pretreated HER2-Low Breast Cancer #BCSM #oncology https://t.co/6o7qUkaJ9c