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ENHERTU® (fam-trastuzumab deruxtecan-nxki) Additional Analyses Further Reinforce Ground-breaking Efficacy in Patients With HER2-positive Metastatic Breast Cancer

New DESTINY-Breast03 data presented at SABCS 2021 showed AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated a similar benefit in patient subgroups, including in patients with stable brain metastases, versus T-DM1

Excerpt from the Press Release:

WILMINGTON, Del.–(BUSINESS WIRE)–New results from the DESTINY-Breast03 Phase III trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki)demonstrated a higher progression-free survival (PFS) and objective response rate (ORR) in pre-specified patient subgroups compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

ENHERTU is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo).

A similar PFS and ORR benefit was observed in exploratory analyses in patients defined by stable brain metastases, hormone receptor status, number of prior lines of therapy, prior pertuzumab treatment, or status of visceral metastasis. Results were presented as an oral presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS).

In patients with stable brain metastases at baseline, treatment with ENHERTU resulted in higher PFS compared to T-DM1 (PFS by blinded independent central review (BICR) hazard ratio [HR] = 0.25; 95% confidence interval [CI]: 0.13-0.45). Additionally, in this subgroup, ENHERTU improved PFS to a median of 15 months versus 3 months for T-DM1.

Sarah Hurvitz, MD, MD, FACP, medical oncologist, professor of medicine, and director of the Breast Cancer Clinical Trials Program in the division of hematology-oncology at the David Geffen School of Medicine at UCLA, and medical director for the Clinical Research Unit at the UCLA Jonsson Comprehensive Cancer Center in Santa Monica, CA, said: “The main goals in the treatment of HER2-positive metastatic breast cancer, including those with stable brain metastases, are to improve symptoms, stabilize or reduce tumor size and improve overall survival. The higher progression-free survival seen in DESTINY-Breast03 in the subgroup of patients with stable brain metastases are encouraging, and underscores the excitement around another potential treatment option for patients who have experienced disease progression on currently available therapies.”

Susan Galbraith,Executive Vice President, Oncology R&D, AstraZeneca, said: “More treatment options are needed to delay progression and extend survival for patients with HER2-positive metastatic breast cancer who develop brain metastases. These additional analyses from DESTINY-Breast03 reinforce the potential of ENHERTU with similar benefits in the different subgroups.”

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