AstraZeneca breast cancer pipeline updates

AstraZeneca (AZ) held its Investor Day, where management provided updates on the company’s business outlooks and its BC pipeline

• The company has ambitionto deliver $80b total revenue and launch 20 new medicines by 2030
• In its oncology presentation, AZ positioned itself as the leader in the “ADC revolution to replace systemic chemotherapy”
  • The company also heavily messaged that it has “the right portfolio”to lead in ADC + IO combinations   
• AZ is messaging that T-DXd (Enhertu, HER2-ADC) will redefine HER2 expression across breast cancer with expected movement of the ADC “earlier and broader”
  • T-DXd stated to move into both the HER2-low and HER2-ultralow subgroups of the chemotherapy-naïve HR+ mBC population through DESTINY-Breast06, representing 85% of this population
• Dato-DXd (TROP2-ADC) is positioned to set “a new standard for TROP2 ADCs in BC” with strong efficacy, differentiated safety and Q3W dosing
  • Key milestones for Dato-DXd remain unchanged from previous guidance, including a readout for P3 TROPION-Breast02(1L TNBC not candidates for anti-PD-(L)1) in H2 2024 and regulatory decisions based on P3 TROPION-Breast01 (2L+ HR+/HER2- mBC with 1L or 2L prior chemo) in 2025
  • Management also discussed how their proprietary quantitative continuous score (QCS) technology can optimize patient selection specifically in reference to using a TROP2 QCS biomarker to predict clinical efficacy of ADCs

• Beyond ADCs, AZ also plans to extend its leadership in BC through targeted oral therapies 
  • Capivasertib (Truqap, AKTi) was stated to be the “first and best-in-class” AKTi establishing a new standard of care and prolonging benefit from ET 
    • Data readout from the Phase 3 CAPItello-290trial (1L TNBC) is still expected in 1H of 2024 though no abstract was listed at ASCO
  • AZ is seeking to establish camizestrant (oral SERD) as the next ET backbone and extend next-gen oral SERDs into early BC
  • The company is also positioning its next-gen PARPi, saruparib, as the first PARPi to generate head-to-head data vs CDK4/6 inhibitors in the 1L HR+ BRCA1/2m/PALB2 setting 
    • AZ seeks to differentiate saruparib through its improved target engagement and safety
    • Readout for the newly listed Phase 3 EvoPAR-BR01trial is guided for >2025

AstraZeneca (AZ) announced that it plans to build a $1.5 billion manufacturing facility in Singapore for ADCs, to enhance global supply of its ADC portfolio

• The planned greenfield facility, supported by the Singapore Economic Development Board (EDB), will be AZ’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale
• The company aims to begin design and construction of the manufacturing facility by YE2024, with targeted operational readiness from 2029
• This investment will likely enhance AZ's global supply capabilities for ADCs and reinforce its leadership position in the ADC market