May 26, 2024

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Daiichi Sankyo/AstraZeneca’s Enhertu Shows Positive Results in Phase III DESTINY-Breast06 Clinical Trial

Daiichi Sankyo/AstraZeneca’s Enhertu Shows Positive Results in Phase III DESTINY-Breast06 Clinical Trial



Daiichi Sankyo/AstraZeneca’s Enhertu Shows Positive Results in Phase III DESTINY-Breast06 Clinical Trial

On April 29, Daiichi Sankyo announced that the Phase III clinical trial of Enhertu, DESTINY-Breast06, has achieved positive top-line results.

Daiichi Sankyo/AstraZeneca's Enhertu Shows Positive Results in Phase III DESTINY-Breast06 Clinical Trial

The study results showed that in the primary trial population, consisting of HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer patients receiving one or more endocrine therapies, Enhertu demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard of care chemotherapy. Additionally, in the overall population, including HER2-low and HER2-negative (IHC 0; IHC >0 <1+) metastatic breast cancer patients, an improvement in PFS was also observed.

Although overall survival (OS) data are not yet mature, early trends of OS improvement compared to standard of care chemotherapy were observed in patients with HER2-low breast cancer and in the overall population. The trial will continue to evaluate OS and other secondary endpoints. Safety profiles were consistent with those observed in previous trials, and no new safety signals were identified. Detailed result data will be presented at an upcoming medical meeting.

DESTINY-Breast06 (DB06) is a Phase III clinical trial for HR-positive HER2-low breast cancer, enrolling patients who have progressed following endocrine therapy and have not received prior chemotherapy (post ET, chemo-naive) for metastatic breast cancer.

The previously positive DB04 trial targeted patients who had received prior endocrine therapy and one to two lines of chemotherapy regardless of HR status. The positive results from DB06 signify a shift in the treatment paradigm for HER2-low breast cancer.

(source:internet, reference only)


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