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Prodotti competitors / Area Oncology

Breast Cancer AZ development updates

  • 5 maggio 2023
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Trastuzumab deruxtecan: 2L+ HR+/HER2-low/-ultralow mBC with prior ET progression but no prior chemo – P3 DESTINY-Breast06 (NCT04494425)

    • Readout continues to be expected in H2 2023 with regulatory submission in 2024

Trastuzumab deruxtecan + durvalumab (anti-PD-L1) / capivasertib (ATKi) / anastrozole (AI) / fulvestrant / chemo (paclitaxel, capecitabine): HER2-low mBC – P1b DESTINY-Breast08 (NCT04556773)

      • Readout is expected in H2 2023

Datopotamab deruxtecan (Dato-DXd; TROP2 ADC): 2L+ HR+/HER2- mBC with 1L or 2L chemo – P3 TROPION-Breast01 (NCT05104866)

    • Readout is expected in H2 2023 (previously 2024+); regulatory submission expected in H2 2023/2024 (previously 2024+)
    • This is an acceleration of 4Q+ based on this update, TB-01 can now potentially gain US approval as early as Q3 2024, 
    • acceleration of recruitment by 6 months was the main reason for the updated readout expectations

Datopotamab deruxtecan: 1L TNBC not candidates for anti-PD-(L)1 – P3 TROPION-Breast02 (NCT05374512)

      • Readout continues to be expected in 2024 with regulatory submission in 2024+

Capivasertib + fulvestrant: 2L HR+/HER2- mBC after AI – P3 CAPItello-291 (NCT04305496)

      • Regulatory submission continues to be expected in H1 2023

Capivasertib + paclitaxel: 1L mTNBC – P3 CAPItello-290 (NCT03997123)

      • Data readout continues to be expected in H2 2023
      • Regulatory submission now expected in 2024 (previously H2 2023)

Camizestrant (oral SERD) + CDK4/6i: 1L ESR1mut, HR+/HER2- mBC – P3 SERENA-6 (NCT04964934)

      • Data readout and regulatory submission are now expected in 2024+ (previously 2024)
    • Adjuvant camizestrant: ER+/HER2- eBC after 2yrs of standard adjuvant ET – P3 CAMBRIA-1 (NCT05774951)
      • Potential readout and regulatory submission are noted to be 2024+
      • the trial design for CAMBRIA-1 (2-5yrs of adjuvant therapy +/- CDK4/6i) is in-line with the any potential standard of care change in the adjuvant setting caused data being presented at ASCO (i.e., the NATALEE trial)

Camizestrant: newly diagnosed ER+/HER2- primary BC – P2 SERENA-3 (NCT04588298)

      • Data is anticipated in H1 2023

Camizestrant ± everolimus (mTOR inhibitor) / capivasertib / anastrozole / CDK4/6i (palbociclib, ribociclib, abemaciclib): 2L+ HR+/HER2- mBC – P1 SERENA-1 (NCT03616587)

      • Data is expected in 2024

Durvalumab + trastuzumab deruxtecan / datopotamab deruxtecan / paclitaxel ± capivasertib / oleclumab: 1L mTNBC – P2 BEGONIA (NCT03742102)

      • Data is expected in H1 2023
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