June 25, 2024

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New breast cancer drug: HER2+ launched in US and Japan

New breast cancer drug: HER2+ launched in US and Japan

New breast cancer drug: HER2+ launched in US and Japan. The AstraZeneca/Daiichi Sankyo antibody conjugate drug Enhertu will soon be approved in the EU and has been launched in the United States and Japan!

AstraZeneca and Daiichi Sankyo recently announced that the European Medicines Agency (EMA) Committee for Human Medicinal Products (CHMP) has recommended granting a conditional marketing authorization for the HER2 targeting antibody conjugate (ADC) Enhertu (trastuzumab deruxtecan) in the EU, as Monotherapy is used to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2 treatment regimens.

New breast cancer drug: HER2+  launched in US and Japan


Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which is expected to make a final review decision within 2 months. In Europe, about 520,000 women with breast cancer are diagnosed each year, and about 20% are HER2 positive. The impact of this disease is huge, with more than 137,000 deaths from breast cancer each year.

Enhertu is developed globally by AstraZeneca and Daiichi Sankyo, and Daiichi Sankyo retains exclusive rights to the Japanese market. In the United States and Japan, Enhertu has been approved for use in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least two HER2 regimens. The approval is based on the tumor response rate (ORR=60.3%) and duration of response (median DOR=14.8 months) data from the registration phase II trial DESTINY-Breast01. Further approval will depend on the verification and description of clinical benefits in confirmatory trials.

In September this year, Enhertu was approved for a new indication in Japan: for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer. Currently, Enhertu’s indications for the treatment of HER2-positive lung cancer are undergoing priority review by the US FDA. About one-fifth of gastric cancer cases are HER2 positive. For patients with metastatic gastric cancer who have progressed after initially receiving an anti-HER2 drug, there are no other approved HER2 targeted drugs.

Enhertu is the first ADC drug approved for the treatment of HER2-positive gastric cancer, and is the first and only one shown to significantly extend overall survival compared to chemotherapy in patients with HER2-positive metastatic gastric cancer who have previously received chemotherapy and anti-HER2 therapy (OS) HER2 targeted therapy. Based on the convincingly strong efficacy in clinical trials, Enhertu will become a new standard of care for the clinical treatment of such patients, bringing meaningful treatment progress to HER2-positive lung cancer.


CHMP’s positive review opinion, based on DESTINY-Breast01, is a pivotal, single-arm, open-label, global, multi-center, two-part trial that evaluated Enhertu (5.4 mg/kg) as a monotherapy for HER2-positive and non-positive Safety and effectiveness in patients with resectable and/or metastatic breast cancer. The study enrolled 184 patients in more than 100 clinical locations around the world. These patients had previously received 2 or more HER2 targeting regimens. The median number of previous therapies for the treatment of metastatic disease was 6 (range: 2- 27). Past treatments include:

  • Trastuzumab-emtansine (T-DM1, 100% of patients),
  • Trastuzumab (100% of patients),
  • Pertuzumab (65.8% of patients),
  • Other anti-HER2 therapies (54.3% of patients),
  • Hormone therapy (48.9% of patients),
  • Other systemic treatments (99.5% of patients).

The primary endpoint of the study was the overall response rate (ORR), which was evaluated by the Independent Central Review Committee (IRC). In the study, the median treatment time of Enhertu was 10 months (0.7-20.5), and the median follow-up time was 11.1 months (0.7-19.9). As of the data cutoff on August 1, 2019, 42.9% of patients are still receiving treatment.

The results of the study have been published in the New England Journal of Medicine (NEJM). The data showed that the ORR of Enhertu single agent (5.4mg/kg) treatment was 60.3% (n=111, 95%CI: 52.9-67.4), of which the complete response rate (CR) was 4.3% (n=8), partial remission The rate (PR) is 56.0%. The disease control rate (DCR) was 97.3%, the median duration of response (DoR) was 14.8 months (95%CI: 13.8-16.9), and the median progression-free survival (PFS) was 16.4 months (95%CI: 12.7-not estimable).

The median overall survival (OS) has not yet been reached, and the estimated one-year survival rate is 86%. The results of all subgroups of patients were consistent. The safety and tolerability of DS-8201 in this study are consistent with those observed in the phase I trial.


About 20% of breast cancer cases are HER2-positive. Although treatment progress has been made in recent years and a number of new drugs have been approved, there is still significant clinical demand in patients with HER2-positive metastatic breast cancer. The disease is still incurable, and patients will eventually progress after receiving currently available treatments. HER2 is a tyrosine kinase receptor growth-promoting protein, expressed on the surface of a variety of tumor cells, including gastric cancer, breast cancer and lung cancer, and is associated with aggressive diseases and poor prognosis.

Enhertu is a new generation ADC drug that combines trastuzumab, a humanized monoclonal antibody targeting HER2 (trastuzumab), and a new topoisomerase 1 inhibitor exatecan derivative ( DX-8951 derivatives, DXd) are linked together, which can target the delivery of cytotoxic agents to cancer cells. Compared with usual chemotherapy, it can reduce the systemic exposure of cytotoxic agents.

In March 2019, AstraZeneca and Daiichi San reached a total value of US$6.9 billion in immuno-oncology cooperation to jointly develop Enhertu to treat cancer patients with various HER2 expression levels or HER2 mutations, including gastric cancer, colorectal cancer and Lung cancer, breast cancer with low HER2 expression. EvaluatePharma, a pharmaceutical market research organization, previously predicted that Enhertu’s sales in 2024 are expected to reach US$2 billion.

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