Datopotamab deruxtecan

TROPION-Lung01 Phase III trial results show TROP2, measured by AstraZeneca's QCS, predicts clinical outcomes in advanced NSCLC patients treated with datopotamab deruxtecan (Dato-DXd), demonstrating greater efficacy in TROP2-QCS positive tumors compared to docetaxel.

TROP2 biomarker, measured by AstraZeneca's QCS, predicts clinical outcomes in NSCLC patients treated with datopotamab deruxtecan in TROPION-Lung01 trial, showing greater efficacy in TROP2-QCS positive tumors. AstraZeneca and Roche collaborate to develop a TROP2-QCS companion diagnostic.

AstraZeneca and Roche Tissue Diagnostics collaborate to co-develop a TROP2-QCS biomarker companion diagnostic, aiming to improve patient care in advanced non-small cell lung cancer (NSCLC) treatment. The partnership leverages AstraZeneca’s QCS computational pathology platform within Roche’s navify® Digital Pathology system, focusing on TROPION-Lung01 trial evaluating datopotamab deruxtecan efficacy in NSCLC.

The article presents various studies on antibody drug conjugates, including datopotamab deruxtecan (Dato-DXd) and trastuzumab deruxtecan (T-DXd), in different cancer types such as endometrial, ovarian, breast, lung, and gastric cancers. It also covers studies on immuno-oncology treatments like durvalumab and neoadjuvant strategies, as well as initial results from first-in-human studies of new antibody-drug conjugates like AZD8205 and AZD5335. Additionally, it discusses the role of circulating tumor DNA (ctDNA) dynamics in treatment responses and long-term survival outcomes in various cancer settings.

Datopotamab deruxtecan's BLA accepted in the US for treating metastatic HR-positive, HER2-negative breast cancer, based on Phase III trial results showing significant PFS improvement over chemotherapy. FDA decision expected Q1 2025.

Daiichi Sankyo and AstraZeneca's Biologics License Application for datopotamab deruxtecan, a TROP2 directed ADC, was accepted in the U.S. for treating advanced nonsquamous NSCLC post-systemic therapy. Based on TROPION-Lung01 trial results, it showed significant PFS improvement over docetaxel, with a favorable OS trend. FDA decision expected by December 20, 2024.