On 22 September, AstraZeneca announced positive interim data for the Phase III TROPION-Breast01 trial evaluating Daiichi Sankyo and AstraZeneca’s datopotomab deruxtecan (Dato-DXd) versus the investigator’s choice of chemotherapy in the second-line metastatic setting for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 (HER2) low or negative breast cancer.

The trial data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

The dual primary endpoint of overall survival (OS) exhibited a trend in improvement; however, the data is immature, and the trial will continue pending full analysis.  

Dato-DXd is an antibody-drug conjugate (ADC) based on Daiichi Sankyo’s proprietary DXd technology.

The drug consists of a trophoblast cell surface antigen 2 (TROP2) monoclonal antibody conjugated with potent topoisomerase I inhibitor payloads via a highly selective, serum-stable, cleavable linker.

TROP2 is a protein broadly expressed in HR+ and HER2 low or negative breast cancer.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The collaboration between AstraZeneca and Daiichi Sankyo has already resulted in the US Food and Drug Administration’s approval of the anti-HER2 ADC Enhertu (trastuzumab deruxtecan) drug for patients with HR+ and HER2-low breast cancer in metastatic or advanced second-line settings. 

Dato-DXd faces a major anti-TROP2 ADC competitor, Gilead’s Trodelvy (sacituzumab govitecan).

Trodelvy is approved for patients with HR+ and HER2 negative locally advanced or metastatic breast with prior endocrine-based therapy and at least two or more systemic therapies.

Trodelvy’s approval was based on the TROPICS-02 trial, which boasted statistically significant PFS and OS benefits.

Based on GlobalData’s analyst consensus forecast, the approval has contributed to predicted annual sales of $3.2bn by 2029.

However, Trodelvy exhibited an underwhelming 1.5-month median PFS benefit versus chemotherapy, allowing Dato-DXd to potentially compete in the PFS space.

Additionally, Trodelvy is approved in the third- to fifth-line setting. If a complete analysis of the TROPION-Breast01 trial confirms positive results, Dato-DXd will effectively dominate in the earlier HER2-negative second-line setting, boosting Dato-DXd’s projected annual sales of $2.4bn by 2029.

Regarding side effects, the announcement stated that there were low rates of all-grade interstitial lung disease without revealing the presence of high-grade events.

Daiichi and AstraZeneca display continued persistence in evaluating Dato-DXd across breast cancer subtypes in their Phase III programme with two additional trials in triple-negative breast cancer and expansion into other solid tumour indications, including non-small cell lung cancer.