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Datopotamab deruxtecan Phase 3 study TROPION-Breast01 positive results for PFS in HR+/HER2- Breast Cancer

  • 22 settembre 2023
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AstraZeneca and Daiichi Sankyo announced that the Phase 3 TROPION-Breast01 study, evaluating datopotamab deruxtecan (dato-dxd; TROP2 ADC) vs. investigator’s choice chemotherapy in HR+/HER2- breast cancer patients who had received 1-2 prior lines of chemotherapy, met its first coprimary PFS endpoint, describing the results as “statistically significant and clinically meaningful.”

A positive trend was observed for the second OS coprimary endpoint, though results were not yet statistically significant the study will continue to further maturity. AZ/Daiichi might seek to file TROPION-Breast01 in the US & EU based on PFS, and look to add positive OS results into the filing once available. Timing approval assumptions: Q4’24 (US) / Q1’25 (EU).

Key Takeaways/Potential Implications

  • TROPION-Breast01 is in a slightly earlier patient population than TROPiCS-02 (1-2 prior chemo vs. 2+ prior chemo), and AZ/Daiichi are likely to position dato-dxd as early as possible, ahead of Trodelvy

    • The patient population included in TROPION-Breast01 is similar in line of therapy to DESTINY-Breast04 (trastuzumab deruxtecan in HER2-low BC), though it is broader as it includes all HR+/HER2-negative patients, including IHC-0

    • AZ/Daiichi are expected to position Dato-DXd in sequence following trastuzumab deruxtecan (Enhertu; HER2 ADC) for eligible metastatic HR+ patients, after the anticipated readout of DESTINY-Breast06 in chemo-naïve patients (results expected 1H 2024)

  • Rates of all-grade ILD, a key AE of concern for dato-dxd, were described as “low” and consistent with prior breast cancer studies

  • assumption is for this data to most likely be presented at ESMO 2023 in Madrid (October 20-24)

  • This is now the second positive P3 study for dato-dxd following TROPION-Lung01 (2L+ NSCLC), announced as having met its PFS endpoint in July 2023

    • Similar to TROPION-Breast01, TROPION-Lung01 (2L+ NSCLC) only met its coprimary PFS endpoint at this first analysis, and is waiting for OS to further mature. Assumption is that AZ/Daiichi will file for both indications near-simultaneously

Additional Information

  • Press release from AZ: [link]

  • Press release from Daiichi (link is a PDF document): [link]

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