The international, open-label, randomised trials will assess the safety and efficacy of datopotamab deruxtecan plus durvalumab in breast cancer patients. Credit: aslysun / Shutterstock.com.

Daiichi Sankyo and AstraZeneca have dosed the first subject in two Phase III clinical trials of TROP2-directed DXd antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), plus durvalumab to treat two types of breast cancer.

Dubbed TROPION-Breast04 and TROPION-Breast05, the international, open-label, randomised trials will assess the safety and efficacy of the treatment combination.

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The double-arm TROPION-Breast04 trial will analyse neoadjuvant Dato-DXd plus durvalumab, followed by adjuvant durvalumab irrespective of chemotherapy status in stage II-III triple negative breast cancer (TNBC) or hormone receptor (HR) low, HER2 low or negative patients. 

It will enrol around 1,700 subjects at trial centres in South America, North America, Oceania Asia, and Europe. 

Apart from TNBC patients, this trial will enrol people with HR low, HER2 low or negative breast cancer with tumours expressing reduced hormone receptor levels. 

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Pathological complete response and event-free survival are the trial’s primary endpoints.

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A three-arm trial, TROPION-Breast05 is designed to assess Dato-DXd monotherapy along with durvalumab in locally recurrent inoperable or metastatic TNBC patients with PD-L1 expressing tumours.

It will have 625 TNBC patients at study centres in North America, Europe, Asia and Oceania. 

Progression-free survival (PFS) as evaluated by a blinded independent central review is the trial’s primary endpoint.

Daiichi Sankyo Oncology Clinical Development global head Mark Rutstein said: “While the addition of immune checkpoint inhibitors to chemotherapy has led to survival improvements for patients with triple-negative breast cancer, the overall prognosis for these patients remains poor. 

“These two Phase III trials will evaluate whether combining datopotamab deruxtecan, a TROP2 directed antibody-drug conjugate, with durvalumab may offer a more effective option for patients across different settings of breast cancer.”

In July 2020, AstraZeneca and Daiichi Sankyo signed an international partnership to co-develop and co-market Dato-DXd, excluding Japan. 

The companies are also advancing two other Phase III trials, TROPION-Breast02 and TROPION-Breast03, of datopotamab deruxtecan in TNBC. 

In October this year, the companies reported positive interim findings from the TROPION-Breast01 trial of Dato-DXd to treat inoperable or metastatic HR-positive, HER2-negative breast cancer patients.