Datopotamab deruxtecan

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 A BLA for datopotamab deruxtecan was withdrawn.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.

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 Daiichi Sankyo's ADC datopotamab deruxtecan for EGFR-mutated NSCLC, based on early TROPION-Lung05 trial results showing clinically meaningful tumor response. The drug, co-developed with AstraZeneca, aims to address significant unmet needs in advanced NSCLC treatment.

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.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation (BTD) in the US for treating EGFRm NSCLC patients progressing after EGFR-TKI and platinum-based chemotherapy. Developed by Daiichi Sankyo and AstraZeneca, the BTD was based on TROPION-Lung05 and TROPION-Lung01 trial data. AstraZeneca and Daiichi Sankyo also submitted a Biologics License Application for accelerated approval.