DAIICHI SANKYO, INC.

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 A BLA for datopotamab deruxtecan was withdrawn.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.

Grace Liu from Sino Biological discusses Antibody-Drug Conjugates (ADCs), a cancer therapy combining precision targeting with potent cytotoxic drugs. ADCs consist of a monoclonal antibody, cytotoxic payload, and linker, balancing efficacy and safety. Sino Biological offers comprehensive ADC development solutions, aiding in the complex process from discovery to clinical studies.

The global Acute Myeloid Leukemia Therapeutics Market is projected to grow at a CAGR of 13.4% during 2024-2032, driven by advances in targeted therapies and immunotherapies.

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.

The first patient has been dosed in the QuANTUM-Wild phase 3 trial evaluating Daiichi Sankyo's VANFLYTA (quizartinib) for newly diagnosed FLT3-ITD negative AML, aiming to reduce relapse risk and improve survival.

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.