Enhertu approved in EU for HER2-positive early breast cancer with residual disease

AstraZeneca and Daiichi Sankyo have received European Commission approval for Enhertu as an adjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant therapy.

Enhertu, also known as trastuzumab deruxtecan, is now approved as a monotherapy for patients whose cancer has been surgically removed but who still had invasive disease after receiving taxane-based chemotherapy and HER2-targeted treatment before surgery.

The decision represents the first European Union approval of Enhertu in the curative-intent early breast cancer setting.

The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is supported by findings from the Phase III DESTINY-Breast05 study.

In the trial, Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine, also known as T-DM1.

The hazard ratio for invasive disease-free survival was 0.47, with a 95% confidence interval of 0.34 to 0.66 and a p value below 0.0001.

At three years, 92.4% of patients receiving Enhertu were alive and free from invasive disease compared with 83.7% of those receiving T-DM1.

DESTINY-Breast05 evaluated patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant treatment, a group that remains at increased risk of recurrence despite receiving therapy before surgery.

Sibylle Loibl, MD, PhD, lead investigator of DESTINY-Breast05, said reducing the likelihood of recurrence is particularly important for patients who continue to have invasive disease after neoadjuvant treatment.

She said the more than 50% reduction in recurrence risk observed with trastuzumab deruxtecan could change treatment approaches for eligible patients in this setting.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said the aim of treatment in early breast cancer is to maximise the likelihood of cure and reduce the chance of long-term recurrence.

He highlighted that more than 92% of patients treated with Enhertu remained alive and free of invasive disease at three years.

The safety profile observed in DESTINY-Breast05 was consistent with the established profile of Enhertu, with no new safety concerns identified.

Enhertu is a HER2-directed DXd antibody drug conjugate developed jointly by AstraZeneca and Daiichi Sankyo.

The treatment is now approved in more than 35 countries for adjuvant treatment of HER2-positive breast cancer with residual invasive disease following neoadjuvant trastuzumab, with or without pertuzumab, and taxane-based therapy.

Following the EU approval, AstraZeneca will make a $75 million milestone payment to Daiichi Sankyo under the companies’ collaboration agreement.

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