AstraZeneca and Daiichi Sankyo have announced that their therapy Enhertu has shown a statistically and clinically meaningful progression-free survival (PFS) improvement in patients with HR-positive, HER2-low metastatic breast cancer.

Enhertu is a specifically engineered HER2-directed DXd antibody-drug conjugate (ADC). It comprises a HER2 monoclonal antibody attached to several topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

This is according to the high-level results from the DESTINY-Breast06 Phase III trial.

The global, randomised, open-label trial is evaluating the safety and efficacy of Enhertu (5.4mg/kg) versus investigator’s choice of chemotherapy in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow advanced or metastatic breast cancer.

The trial also indicated a significant PFS improvement in the overall patient population, including those with HER2-ultralow expression.

A subgroup analysis revealed that the clinical benefits were consistent across patients with varying levels of HER2 expression.

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While overall survival (OS) data are not yet mature, an early trend towards OS improvement was observed.

The DESTINY-Breast06 trial is designed to compare Enhertu with standard-of-care chemotherapy in patients who have received prior endocrine therapy.

The trial’s primary endpoint is PFS in the HR-positive, HER2-low patient population and key secondary endpoints include OS and PFS in the overall trial population.

A total of 866 patients from Asia, Europe, North America, and South America were enrolled in the DESTINY-Breast06 trial. The trial continues to assess OS and other secondary endpoints.

AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “DESTINY-Breast06 shows that Enhertu could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy.

“These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer.”

The collaboration between AstraZeneca and Daiichi Sankyo began in March 2019, with the aim to jointly develop and commercialise Enhertu globally, except in Japan where Daiichi Sankyo holds exclusive rights.

Daiichi Sankyo will manufacture and supply Enhertu.