Daiichi Sankyo oncology pipeline updates

On Apr 25, 2024, Daiichi Sankyo (DS) reported their FY2023 (Q2’23 – Q1’24) earnings (Financial Results, Reference Data, Presentation, Webcast) where the company provided updates on their oncology pipeline.  

Key Oncology Highlights:

• Daiichi-Sankyo updated its strategic pillars – based on the progress of I-DXd (B7-H3 ADC) and DS-6000 (CDH6 ADC) their R&D strategy has shifted from “3 ADCs and Alpha” to “5 DXd ADCs and Next Wave”
  • DS also noted that ADC competition is now “harsher” and to maximize the DXd franchise, they needed to enhance their “capacity resource capabilities” and provide products to “as many patients at an earlier stage” through the joint development efforts with Merck

• Key updates to their breast cancer pipeline include:
  • The filing acceptance of datopotamab deruxtecan (Dato-DXd; TROP2-ADC) based on the results of the Phase 3 TROPION-Breast01 trial in 2L+ HR+/HER2- mBC occurred in Q1 2024 in the US (PDUFA data Jan 29, 2025), EU, China, and Japan
  • Data readout for the Phase 3 DESTINY-Breast06 trial of trastuzumab deruxtecan (T-DXd, HER2-ADC) in 2L+ chemo-naïve HR+/HER2-low/ultralow mBC continues to be expected in Q2/Q3 2024 (JP H1 FY2024); AZ continues to guide for a H1 2024 readout
  • Data readout for the Phase 3 TROPION-Breast02 trial of Dato-DXd in 1L PD-(L)1 ineligible TNBC is now expected in Q4 2024 – Q1 2025 (JP H2 FY2024) [previously Q2 2024 – Q1 2025 (JP FY2024)]; AZ continues to guide for a H2 2024 readout

• Key Updates to their NSCLC pipeline include:
  • Management reiterated that the regulatory decision for Dato-DXd (TROP2 ADC) in 2-3L adv/mNSCLC (TROPION-Lung01) is still on track for approval with a PDUFA date of December 20th, 2024; no additional details provided on OS FA data timing
  • Management highlighted the two new 1L NSCLC Dato-DXd trials in combination with rilvegostomig (TIGIT/PD-1 bispecific) and osimertinib (EGFR TKI)

• No major updates were provided for UC, SCLC, or GYN