Prodotti competitors / Area Oncology
Datopotamab deruxtecan development UPDATES
- Regulatory submission acceptance for Phase 3 Dato-DXd studies TROPION-Breast01 in 2L+ HR+/HER2- mBC and TROPION-Lung01 in 2L+ NSCLC continues to be expected in H1 2024 (Q1’24 based on guidance from partner Daiichi)
- Dato-DXd is positioned to be the 2nd to market TROP2-ADC with the ability to enter the HR+/HER2- mBC setting in an early LoT, though data presented at ESMO 2023 did not significantly differentiate Dato-DXd from Trodelvy in TROPiCS-02 (HR: 0.63 vs 0.66)
- TROPION-Lung01 was notably absent from the presentation remarks and only referenced once in the Q&A
- Readouts for other Phase 3 trials in breast cancer:
- DESTINY-Breast06 (T-DXd, 2L+ HR+/HER2-low/-ultralow mBC; H1 2024) and CAPItello-290 (capivasertib, 1L mTNBC) in H1 2024,
- TROPION-Breast02 (Dato-DXd, 1L TNBC) in H2 2024
- Results for P3 AVANZAR in 1L NSCLC are expected in 2025, and are now potentially expected ahead of P3 TROPION-Lung07 & TROPION-Lung08
- Management highlighted the potential US pan-tumor approval of Enhertu (PDUFA May 30, 2024) as being an expected mid-term growth driver, and hinted at plans to fill the “white space” of HER2-low settings with additional trials
- Management emphasized their wholly owned portfolio of 6 ADCs and bispecific platform, noting that this IO + ADC combination can differentiate AstraZeneca in oncology
Financials
- Total YE revenue $45,811m, up 6% despite the decline from COVID-10 medicines
- Total revenue growth from oncology 21%, CVRM 18%, R&I 10%, and rare disease 12%
- Global product sales for trastuzumab deruxtecan (Enhertu, T-DXd; HER2 ADC) of $83 million (>3x YoY CER) in Q4 2023 and $261 million (>3x YoY CER) in FY 2023
- AZ noted a strong initial launch for capivasertib (Truqap, ATKi) with US product sales of $6 million (n/m YoY) in Q4 and FY 2023
Sources: press release, presentation, results announcement, and clinical trials appendix
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