New HER2-positive breast cancer drug!

AstraZeneca and Daiichi Sankyo have recently announced that the U.

BTD is a new drug review channel of the FDA, which aims to accelerate the development and review of new drugs that are used to treat serious or life-threatening diseases and have preliminary clinical evidence that compared with existing therapeutic drugs, they have significantly improved clinically important endpoints

The latest BTD, based on the results of the groundbreaking head-to-head Phase 3 DESTINY-Breast03 trial: Compared with Roche's HER2 targeted ADC product Kadcyla (trastuzumab emtansine, T-DM1), Enhertu reduces the risk of disease progression or death by 72%

Breast cancer is still the most common cancer in the world, with more than 2 million cases diagnosed in 2020, resulting in nearly 685,000 deaths worldwide

Kadcyla is a targeted drug that has been approved for the treatment of the aforementioned HER2-positive breast cancer patients

The detailed positive results of the DESTINY-Breast03 trial were announced at the 2021 European Society of Medical Oncology (ESMO) virtual conference in September this year.

The data released at the meeting showed that in the pre-specified interim analysis, the DESTINY-Breast03 trial reached the primary endpoint of progression-free survival (PFS): Compared with Kadcyla, Enhertu significantly reduced the risk of disease progression or death by 72% (HR= 0.

In terms of the key secondary endpoints of PFS assessed by the investigator, the median PFS of the Enhertu group was 3 times that of the Kadcyla group (25.

In addition, in terms of the overall survival (OS) of the key secondary endpoint: Compared with the Kadcyla group, the Enhertu group showed a strong trend of improvement (HR=0.

Compared with the Kadcyla group, the confirmed objective response rate (ORR) in the Enhertu group more than doubled (79.

In this trial, Enhertu's safety was consistent with previous clinical trials, and no new safety issues were found

DESTINY-Breast03 test results

In March 2019, AstraZeneca and Daiichi San reached a total value of US$6.

Enhertu is a new-generation ADC drug that combines trastuzumab (trastuzumab), a humanized monoclonal antibody targeting HER2 with 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.

Up to now, Enhertu (5.

Breast cancer is the most common type of cancer in women and one of the leading causes of cancer-related deaths in women

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Original source: Enhertu granted Breakthrough Therapy Designation in US for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens