Daiichi Sankyo today announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or ultralow (IHC 0 with membrane staining) unresectable or recurrent breast cancer.

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide, with more than 665,000 deaths globally.1 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2022.2 Hormone receptor (HR) positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.3 It is estimated that approximately 60% to 65% of HR positive, HER2 negative breast cancers are HER2 low and potentially an additional 25% may be HER2 ultralow.4,5

The sNDA is based on data from the DESTINY-Breast06 phase 3 trial presented as a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and recently published in The New England Journal of Medicine.

“This submission builds on the current HER2 low indication and if approved will provide the opportunity for the earlier use of ENHERTU for patients with HER2 low expression as well as expanding into the HER2 ultralow patient population,” said Toshinori Agatsuma, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “The DESTINY-Breast06 results represent the first time a HER2 directed therapy has shown a clinically meaningful benefit in these patient populations and we look forward to working with regulatory authorities in Japan to bring ENHERTU to these patients.”
 
Additional regulatory submissions for ENHERTU based on data from DESTINY-Breast06 are under review in the EU and U.S.

DESTINY-Breast06 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab paclitaxel) in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and received at least two lines of prior endocrine therapy in the metastatic setting. Patients also were eligible if they had received one prior line of endocrine therapy combined with a CDK4/6 inhibitor in the metastatic setting and experienced disease progression within six months of starting first-line treatment or received endocrine therapy as an adjuvant treatment and experienced disease recurrence within 24 months.

The primary endpoint is progression-free survival (PFS) in the HR positive, HER2 low patient population as measured by blinded independent central review (BICR). Key secondary endpoints include PFS by BICR in the overall trial population (HER2 low and HER2 ultralow), overall survival (OS) in patients in the HER2 low patient population and OS in the overall trial population. Other secondary endpoints include objective response rate, duration of response, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. Analysis of the HER2 ultralow subgroup was not powered to demonstrate statistical significance.

DESTINY-Breast06 enrolled 866 patients (n=713 for HER2 low and n=153 for HER2 ultralow) at multiple sites in Asia, Europe, North America, Oceania and South America. 

 

Source: daiichisankyo.com

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