Key Takeaways:
(Bloomberg) -- AstraZeneca Plc and Daiichi Sankyo Co.’s Datroway received US approval for patients with a hard-to-treat form of breast cancer after trials showed it extended survival by five months, offering a new initial therapy for a large portion of patients.
“Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the first-line setting compared to chemotherapy in patients with metastatic triple negative breast cancer who are not candidates for immunotherapy,” said Tiffany A. Traina, Section Head of the Triple Negative Breast Cancer Clinical Research Program at Memorial Sloan Kettering Cancer Center and an investigator for the trial.
The Food and Drug Administration’s decision was based on the Phase III TROPION-Breast02 trial, where Datroway (datopotamab deruxtecan-dlnk) demonstrated a median overall survival of 23.7 months, a 5.0-month improvement over the 18.7 months for those on chemotherapy. The drug, a TROP2-directed antibody-drug conjugate (ADC), reduced the risk of disease progression or death by 43 percent (Hazard Ratio: 0.57) and showed an objective response rate of 64 percent, more than double the 30 percent for chemotherapy.
The approval carves out a new standard of care for the roughly 70 percent of patients with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, and for whom chemotherapy was previously the only first-line option. TNBC is an aggressive form of breast cancer that accounts for about 15 percent of cases.
The safety profile of Datroway was consistent with previous trials, with the most common adverse reactions including stomatitis (mouth sores), nausea, and alopecia. The approval comes as AstraZeneca prepares to showcase a wide range of data at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, underscoring the depth of its cancer-drug pipeline.
The company will present more than 85 abstracts, including late-breaking data for other key oncology assets. Highlights include five-year survival data for Imfinzi in bladder cancer (POTOMAC), final results for the breast cancer drug camizestrant (SERENA-6), and additional findings for Enhertu (DESTINY-Breast09), another ADC developed in partnership with Daiichi Sankyo.
“New data for Enhertu, Datroway and camizestrant reinforce their transformational potential in breast cancer,” Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said in a statement.
The approval solidifies AstraZeneca and Daiichi Sankyo’s position in the competitive ADC market. The application was reviewed under the FDA’s Project Orbis initiative, and reviews are ongoing in other regions including the EU, Australia, and Canada.
This article is for informational purposes only and does not constitute investment advice.
