Trastuzumab deruxtecan: AstraZeneca India Pharma unveils HER-2 positive metastatic breast cancer therapy

The global burden of breast cancer, identified by the World Health Organization (WHO) as the most diagnosed cancer, exceeded 2 million cases in 2020. In India, the incidence of breast cancer has surged by a significant 40% over the past 25 years.

Dr. Meenu Walia, Vice Chairman-Medical Oncology, Max Super Speciality Hospital, said, “Trastuzumab deruxtecan is a significant advancement in our treatment options against HER2-positive breast cancer. This innovative therapeutic agent has shown remarkable efficacy in the treatment of HER2-positive breast cancer, a subtype known for its aggressive nature. This antibody-drug conjugate's ability to specifically bind to HER2 receptors and deliver its cytotoxic payload directly to cancer cells has translated into breakthrough clinical outcomes for many patients globally and has become the standard of care in second line. The impressive response rates with manageable safety profiles observed in clinical trials underscore its potential as a transformative option for patients suffering from HER2 expressing metastatic breast cancer in India. The drug’s launch in India will be a big moment for hundreds of patients in the country.”

Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said, “There are huge unmet needs for patients with HER-2 positive metastatic Breast cancer who have already progressed on initial anti-Her-2 targeted treatment and hence pressing need to swiftly provide this transformative medicine to patients. AstraZeneca's commitment to redefining cancer care and eradicating cancer as a cause of death is at the forefront of our scientific advancements. Our recent therapeutic breakthrough brings hope to patients with unresectable or metastatic conditions after prior anti-HER2 treatments. This innovative drug solidifies our dedication to science-driven innovations, representing a significant stride in our fight against breast cancer.”

The introduction of Trastuzumab deruxtecan is supported by positive results from the DESTINY-Breast03 trial, a global Phase III study. Primary results, published in The New England Journal of Medicine, reveal a remarkable 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1). Updated results, published in The Lancet, demonstrate a 36% reduction in the risk of death versus T-DM1. An estimated 77.4% of patients treated with Trastuzumab deruxtecan were alive at two years, emphasizing the persistent impact of this innovative therapy across various patient subgroups. Median progression-free survival, as determined by blinded independent central review, was an impressive 28.8 months with Trastuzumab deruxtecan compared to 6.8 months with T-DM1, further solidifying its position as a breakthrough in breast cancer treatment.

The company received approval to import and market Trastuzumab deruxtecan from the Drug Controller General of India (DCGI) in May 2023.