Daiichi Sankyo Company (4568) Status Update summary

Strategic pipeline and R&D updates

• Significant progress in the DXd ADC pipeline, with ENHERTU showing efficacy in HER2-low and ultra-low breast cancer and regulatory submissions underway globally.

• Dato-DXd received FDA Breakthrough Therapy designation for EGFR-mutated non-small cell lung cancer, with accelerated approval submission based on TROPION-Lung05 and supporting data.

• Multiple pivotal trials in breast and lung cancer are ongoing, with key readouts for DESTINY-Breast09, DESTINY-Breast05, and DESTINY-Breast11 expected in 2025.

• Expansion into other cancers includes pan-tumor approvals and new studies in biliary tract and ovarian cancer, as well as next-generation ADCs and combination strategies.

• External innovation hubs established in Cambridge and Munich to foster collaborations and accelerate research.

Key achievements and recognitions

• ENHERTU® won the 2024 Prix Galien USA Award for Best Biotechnology Product, highlighting its innovation in oncology.

• All 5DXd ADCs received 'Most Promising Clinical Candidate' awards at the 2024 World ADC Awards, reflecting industry recognition of pipeline strength.

• Twelve breakthrough therapy designations have been granted across ENHERTU®, Dato-DXd, HER3-DXd, VANFLYTA®, and TURALIO®, underscoring clinical impact.

Clinical data and biomarker innovation

• DESTINY-Breast06 demonstrated ENHERTU's robust efficacy and safety across subgroups, including those with rapid progression and high disease burden.

• Dato-DXd pooled analysis in EGFR-mutated NSCLC showed a 43% response rate and favorable safety, supporting regulatory filings.

• Advanced digital and computational pathology (QCS-NMR) is being used to refine patient selection and improve predictive biomarkers, especially for Dato-DXd.

• Precision medicine strategies are being integrated across the pipeline, leveraging large datasets and AI-driven multiplex IHC for translational research.

• Biomarker-driven trials are planned for Dato-DXd and other ADCs, with ongoing collaborations with AstraZeneca and Merck to expand digital pathology capabilities.