Daiichi Sankyo Company (4568) Status Update summary

Strategic highlights and pipeline overview

• DXd ADC technology platform drives oncology innovation, with a robust pipeline including Enhertu, Dato-DXd, HER3-DXd, I-DXd, and DS-6000.

• Over 30 presentations across 8 assets at ASCO 2024, focusing on breast and lung cancer programs.

• New phase 3 trial TROPION-Lung15 to start in FY2024, targeting EGFR-mutated NSCLC.

DESTINY-Breast06 (DB-06) pivotal trial results

• T-DXd showed statistically significant and clinically meaningful PFS benefit over chemotherapy in HR+, HER2-low and ultralow metastatic breast cancer, with median PFS of 13.2 vs 8.1 months (HR 0.62, P<0.0001).

• Confirmed ORR was 57.3% for T-DXd vs 31.2% for chemotherapy in the ITT population.

• Approximately 85% of HR+, HER2-negative metastatic breast cancer patients could benefit from T-DXd after DB-06 data.

• Consistent efficacy observed in both HER2-low and ultralow populations.

• No new safety signals identified; interstitial lung disease remains a key risk, with incidence of 11.3%.

DESTINY-Breast03 and DESTINY-Breast07 updates

• DESTINY-Breast03: T-DXd median OS reached 52.6 months vs 42.7 months for T-DM1, confirming superiority.

• DESTINY-Breast07: First-line T-DXd (with/without pertuzumab) showed robust and durable response rates (76%-84%) in HER2+ metastatic breast cancer.

• 12-month PFS rates in DESTINY-Breast07 were 80.8% and 89.4% for monotherapy and combination arms.

• Safety profiles manageable and consistent with known data; no new cumulative toxicities observed.

• Supports ongoing phase 3 DESTINY-Breast09 trial evaluating T-DXd regimens versus standard THP.