Daiichi Sankyo Announces Japanese Approval of Enhertu for HER2-Low Metastatic Breast Cancer

On March 27, Daiichi Sankyo announced that Enhertu has been approved in Japan for its fourth indication, for the second-line treatment of patients with unresectable or metastatic HER2-low breast cancer who have failed chemotherapy.

The approval by Japan's Ministry of Health, Labour and Welfare (MHLW) this time is mainly based on the positive data from the Phase III DESTINY-Breast04 study. This study is a multicenter, randomized, open-label, active-controlled clinical trial designed to evaluate the efficacy and safety of Enhertu (5.4mg/kg) compared to Physician's Choice (PC) treatment in patients with HER2-low/HR-positive (n=494) or HER2-low/HR-negative (n=63) unresectable and/or metastatic breast cancer who have previously received first- or second-line chemotherapy.

The PC regimen is a chemotherapy regimen, including capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel. Patients were randomly assigned in a 2:1 ratio to receive either Enhertu or chemotherapy. The primary endpoint of the study was progression-free survival (PFS) in HR-positive patients as assessed by blinded independent central review (BICR). Key secondary endpoints included PFS and overall survival (OS) in the overall population as assessed by BICR, as well as OS in HR-positive patients.

The results showed that, compared with the chemotherapy group, the PFS of HER2-low/HR-positive breast cancer patients in the Enhertu group was significantly prolonged (10.1 vs 5.4 months; HR=0.51; P<0.001), and the PFS of the overall population was also significantly prolonged (9.9 vs 5.1 months; HR=0.50; P<0.001). Additionally, the OS of HER2-low/HR-positive breast cancer patients in the Enhertu group was significantly longer than that in the chemotherapy group (23.9 vs 17.5 months; HR=0.64; P=0.003), and the OS of the overall population was also significantly prolonged (23.4 vs 16.8 months; HR=0.64; P=0.001).

DESTINY-Breast04 Study Data (Source: NEJM)

In terms of safety, the most common adverse events (AEs) were nausea (73.0%), fatigue (47.7%), alopecia (37.7%), vomiting (34.0%), anemia (33.2%), and decreased neutrophil count (33.2%). Additionally, the incidence of interstitial lung disease (ILD) in the Japanese patient population was 26.8%.

Breast cancer is one of the most common cancers and a leading cause of cancer-related deaths worldwide. In 2020, there were over 2 million confirmed cases of breast cancer globally, with nearly 685,000 deaths. Breast cancer is the most common cancer among women in Japan. In 2020, there were approximately 92,000 confirmed cases and 17,000 deaths from breast cancer in Japan.

Previously, Enhertu has been approved for three indications in Japan: 1) Second-line treatment of HER2-positive unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer; 2) HER2-positive unresectable or recurrent breast cancer after chemotherapy failure; 3) Second-line treatment of unresectable or metastatic HER2-low breast cancer after chemotherapy failure.

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