Daiichi Sankyo and AstraZeneca Launch Phase IIIb DESTINY-Breast15 Trial of Trastuzumab Deruxtecan in HER2-Low and HER2-Zero Metastatic Breast Cancer

On July 18, Daiichi Sankyo registered a Phase IIIb, multicenter, global, interventional, open-label study (DESTINY-Breast15) on clinicaltrials.gov for trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki, T-DXd, DS-8201) in patients with unresectable and/or metastatic HER2-low or HER2 immunohistochemistry (IHC) 0 (including both HR-negative and HR-positive patients) breast cancer.

The study plans to enroll 250 subjects and is scheduled to begin in October 2023. The primary endpoint of the study is the time to next treatment (TTNT), which is defined as the interval from the first dose of trastuzumab deruxtecan to the start of the next anticancer treatment or death from any cause. This metric will determine the duration of clinical benefit that patients derive from trastuzumab deruxtecan.

Trastuzumab deruxtecan (trade name: Enhertu) is an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) jointly developed by Daiichi Sankyo and AstraZeneca.

Trastuzumab Deruxtecan Achieves Significant Success in the DESTINY-Breast03 Study for Second-Line Treatment of HER2+ (IHC 3+, IHC 2+/ISH+) Advanced Breast Cancer Compared Head-to-Head with Trastuzumab Emtansine, Gaining Regulatory Approval.

Based on the results of the DESTINY-Breast04 study, trastuzumab deruxtecan has also been approved by multiple regulatory agencies for the treatment of adult patients with unresectable or metastatic breast cancer who have HER2-low expression (IHC 1+ or IHC 2+/ISH-) and have received at least one prior systemic therapy in the metastatic setting, or who experienced recurrence during or within 6 months after completing adjuvant chemotherapy.

Now, in the newly launched DESTINY-Breast15 study, trastuzumab deruxtecan has included patients with IHC 0 for the first time.

As trastuzumab deruxtecan continues to "expand its territory" in the breast cancer field and reach more benefiting populations, this will also drive its sales performance to soar. In the fiscal year 2022, Enhertu's total revenue reached 207.5 billion yen (approximately 1.556 billion US dollars, including AstraZeneca's share), representing a year-on-year increase of 217.5%.

An article previously published in Nature reported that the global market size of ADC drugs expected to be on the market by 2026 will exceed $16.4 billion, with Trastuzumab Deruxtecan forecasted to rank first with $6.2 billion in sales.

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