AstraZeneca and Daiichi Sankyo's Datroway Shows Promise in Triple-Negative Breast Cancer
AstraZeneca and Daiichi Sankyo have announced groundbreaking results for their antibody-drug conjugate (ADC) Datroway in the treatment of triple-negative breast cancer (TNBC). The drug has demonstrated significant improvements in overall survival and progression-free survival compared to standard chemotherapy, potentially marking a turning point in the treatment of this aggressive form of cancer.
Landmark Phase 3 Trial Results
In a pivotal Phase 3 trial, Datroway achieved its dual primary endpoints for patients with locally recurrent inoperable or metastatic TNBC who are ineligible for immunotherapy. The study showed statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.
Susan Galbraith, AstraZeneca's head of oncology and hematology R&D, stated, "We expect today's results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options."
This breakthrough is particularly significant as it represents the first time a survival benefit has been observed compared to chemotherapy in TNBC patients unable to receive immunotherapy, who account for approximately 70% of TNBC cases.
Expanding Treatment Landscape for TNBC
TNBC, which accounts for 15% of breast cancer cases, is known for its aggressive nature and poor prognosis. It is more frequently diagnosed in younger women and those of Black or Hispanic ethnicity. The median overall survival rate for TNBC patients is currently only 12 to 18 months, with a mere 14% of patients surviving five years post-diagnosis.
Datroway's success in this trial could potentially revolutionize the standard of care for TNBC patients. Ken Takeshita, Daiichi Sankyo's global head of research and development, described the results as "landmark," emphasizing their potential to change the treatment landscape for TNBC patients who currently rely on chemotherapy as their primary option.
Datroway's Mechanism and Future Prospects
Datroway is designed to target the TROP2 protein, which is overexpressed in multiple cancer types. This latest success adds to the drug's growing list of indications, following its FDA approvals earlier this year for certain types of breast and lung cancers.
AstraZeneca and Daiichi Sankyo are not resting on their laurels, with three additional Phase 3 studies underway investigating Datroway in combination with AstraZeneca's PD-L1 inhibitor Imfinzi across various stages and treatment settings of TNBC.
The companies plan to present detailed data from the TROPION-Breast02 trial at an upcoming medical meeting and will submit the results to global health regulators "as soon as possible." This move could potentially lead to a swift expansion of Datroway's approved indications, further solidifying its position in the oncology market.
References
- AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer
The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.
- AZ, Daiichi score 'landmark' results for ADC Datroway in triple-negative breast cancer
AstraZeneca and Daiichi Sankyo’s Datroway has become the first cancer drug to show an overall survival benefit against chemotherapy for certain patients with a particularly aggressive form of breast cancer. In a phase 3 trial, the antibody-drug conjugate has scored as a first-line treatment for those with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy is not an option.
Explore Further
What are the detailed efficacy and safety outcomes of the Datroway Phase 3 trial compared to standard chemotherapy?
What is the current competitive landscape for triple-negative breast cancer treatments, and how does Datroway compare to other marketed therapies?
What is the estimated market size for Datroway in the treatment of triple-negative breast cancer, and what factors could influence its adoption?
What advancements does Datroway's mechanism of targeting the TROP2 protein provide over existing therapies?
How do the ongoing Phase 3 studies involving Datroway in combination with Imfinzi align with AstraZeneca and Daiichi Sankyo's broader oncology strategy?