A groundbreaking new drug developed by AstraZeneca and Daiichi Sankyo has shown promising results in a recent clinical trial focused on aggressive and hard-to-treat breast cancer. This success could lead to the approval of a treatment for one of the most challenging forms of the disease.
The antibody-drug conjugate, known as Datroway, demonstrated an unprecedented improvement in overall survival compared to traditional chemotherapy. In the trial, patients treated with Datroway experienced a median overall survival of 23.7 months, compared to 18.7 months for those on chemotherapy. Additionally, the progression-free survival was almost doubled in the Datroway group, with patients going 10.8 months without disease advancement, compared to 5.6 months in the chemotherapy group.
The phase 3 study, titled TROPION-Breast02, enrolled nearly 650 participants with inoperable metastatic breast cancer who were not eligible for immunotherapy. These patients had triple-negative breast cancer, a subtype characterized by the absence of three specific proteins that are often targeted by treatments. Datroway, designed to target the protein TROP2 expressed in multiple cancers, showed promising results in shrinking tumors and reducing the risk of death by 21%.
According to Mohit Manrao, head of AstraZeneca’s U.S. oncology division, these results offer hope to patients with aggressive triple-negative breast cancer. The trial met its main goals by significantly reducing the risk of disease progression or death by 43%.
Datroway has already been approved for previously treated metastatic breast cancer and certain types of advanced lung cancer. The drug’s performance in this trial, along with its tolerable side effects, positions it as a strong competitor to Gilead’s Trodelvy, another antibody-drug conjugate targeting TROP2.
While Trodelvy has shown success in previous trials, Datroway’s slightly better clinical profile in terms of progression-free survival may give it a competitive edge in the market. Further discussions with global regulators are underway to pave the way for Datroway’s potential approval as a groundbreaking treatment for hard-to-treat breast cancer.