Datopotamab deruxtecan

AstraZeneca and Daiichi Sankyo withdrew the EU MAA for datopotamab deruxtecan (Dato-DXd) in advanced NSCLC based on EMA feedback, but remain committed to its development. Dato-DXd, a TROP2-directed ADC, showed significant PFS improvement in the TROPION-Lung01 trial. The application for HR-positive, HER2-negative metastatic breast cancer remains under review.

Daiichi Sankyo and AstraZeneca withdrew the EU MAA for datopotamab deruxtecan (Dato-DXd) for NSCLC based on EMA feedback. They remain committed to its development for lung cancer patients in the EU.

2024 saw mixed progress in NSCLC treatment and screening. Sacituzumab govitecan failed to improve OS in EVOKE-01 trial. A BLA for datopotamab deruxtecan was withdrawn. Comprehensive genomic profiling (CGP) was emphasized to address testing gaps. Updated guidelines expanded lung cancer screening eligibility by removing quit time and reducing pack-year criteria.

The FDA granted Breakthrough Therapy Designation (BTD) to datopotamab deruxtecan for EGFR-mutated NSCLC, based on TROPION-Lung05 and TROPION-Lung01 trial data. Presented at ESMO Asia 2024, it highlights the drug's potential to address unmet needs in post-treatment disease progression.

OncLive's OncFive highlights top 5 oncology stories: 1) Acalabrutinib/Venetoclax combo improves PFS in frontline CLL. 2) Daratumumab boosts PFS and extends OS in smoldering myeloma. 3) Imlunestrant with or without abemaciclib improves PFS in ESR1+, ER+/HER2- advanced breast cancer. 4) Camrelizumab/chemo boosts pCR in early or locally advanced TNBC. 5) FDA grants breakthrough therapy designation to Dato-DXd for EGFR+ NSCLC.

Daiichi Sankyo initiated the Phase III QuANTUM-Wild trial of oral Vanflyta (quizartinib) for newly diagnosed FLT3-ITD negative AML. The placebo-controlled, double-blind trial aims to assess Vanflyta with standard intensive induction and consolidation therapy, HSCT, and post-maintenance monotherapy in subjects aged 18-70. The global trial plans to enroll nearly 700 subjects across continents, with overall survival as the primary endpoint.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFRm NSCLC progressing after EGFR-TKI and platinum-based chemotherapy. The FDA granted this based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trial data, presented at ESMO Asia 2024. Datopotamab deruxtecan, a TROP2-directed ADC, is jointly developed by AstraZeneca and Daiichi Sankyo, with potential to address significant unmet needs in EGFRm NSCLC treatment.

AstraZeneca and Daiichi Sankyo's Dato-DXd received FDA Breakthrough Therapy designation for EGFRm NSCLC, based on phase II and III study data. They submitted a new BLA for accelerated approval in this indication and withdrew an earlier BLA for nonsquamous NSCLC. Dato-DXd is also under review for HR+ HER2- breast cancer, with regulatory applications ongoing globally.

The FDA granted Breakthrough Therapy Designation to AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) for EGFR-mutated NSCLC patients who progressed after EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 and TROPION-Lung01 trials. Lung cancer is the leading cause of cancer deaths in the US, with NSCLC accounting for 80-85% of cases.