Daiichi Sankyo and AstraZeneca Announce Positive Phase III DESTINY-Breast11 Results for Enhertu in High-Risk HER2-Positive Early Breast Cancer

On May 7, Daiichi SankyoAstraZeneca jointly announced,In regard toHigh-risk HER2-positive earlyDESTINY-Breast11 Study in Breast CancerIn China,PreoperativeAccept Enhertu(Trastuzumab Deruxtecan)Combined THP（(Paclitaxel, Trastuzumab, and Pertuzumab)Treatment,Pathological Complete Response Rate in Patients（pCR）Significant Improvement, and is clinically significant.

Source: AstraZeneca Official Website

DESTINY-Breast11 is aGlobal, Multicenter, Randomized, Open-Label Phase III Clinical Trial`, aimed at evaluating`Trastuzumab Deruxtecan（5.4mg/kg）Monotherapy orTrastuzumab Deruxtecan followed byTHP and Standard Treatment Regimens（ddAC-THP）Compared to the efficacy and safety in patients with high-risk, locally advanced, or inflammatory HER2-positive early breast cancer.

The study recruited participants at multiple trial centers in Asia, Europe, North America, and South America.927 subjects, randomly assigned 1:1:1 to receiveTrastuzumab Deruxtecan Monotherapy,Trastuzumab Deruxtecan +THP、ddAC-THP treatment. The primary endpoint of the study ispCR, secondary endpoints include event-free survival (EFS), invasive disease-free survival, overall survival, and safety.

The results showed that, compared with the standard treatment regimen,Trastuzumab Deruxtecan Combined with THPInHigh-risk, locally advanced HER2-positive early breast cancer patientsIn neoadjuvant therapy, pCR was significantly improved, with statistical and clinical significance.EFS is not yet mature, but the early efficacy trend is favorable.

In terms of safety,Compared with ddAC-THP,Trastuzumab DeruxtecanThe safety of combination THP therapy has improved.Safety of Trastuzumab Deruxtecan and THPConsistent with the known safety profiles of each, no new safety concerns were identified. As assessed by the Independent Review Committee,Trastuzumab DeruxtecanCombination of THP Therapy and ddAC-THP TherapyThe incidence of interstitial lung disease was similar.

Trastuzumab DeruxtecanHas demonstrated improved efficacy in six Phase III clinical trials targeting different subtypes and stages of breast cancer, including first-line treatment for HER2-positive metastatic breast cancer (see:First in a Decade! Daiichi Sankyo/AstraZeneca's "Trastuzumab Deruxtecan" Phase III Interim Analysis Yields Positive Results。）

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