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AstraZeneca’s Enhertu recommended for approval in the EU

Susan Galbraith

AstraZeneca and Daiichi Sankyo’s Enhertu has been recommended for approval in the European Union as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

“Gastric cancer is usually diagnosed in the advanced stage in many European countries and patients face high mortality rates. If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade,” says Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

The DESTINY-Gastric02 and the DESTINY-Gastric01 Phase II trials

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DESTINY-Gastric02 and the DESTINY-Gastric01 Phase II trials.

In DESTINY-Gastric02, conducted in patients from North America and Europe, updated results showed treatment with Enhertu resulted in a confirmed objective response rate (ORR) of 41.8% as assessed by independent central review (ICR). Median duration of response (DoR) was 8.1 months and median overall survival (OS) was 12.1 months. Primary results from the DESTINY-Gastric02 Phase II trial were presented at the 2021 European Society for Medical Oncology (ESMO) Congress, with the updated data presented at ESMO 2022.1

In DESTINY-Gastric01, conducted in patients from Japan and South Korea, updated results showed treatment with Enherturesulted in an ORR of 51.3% versus 14.3% with chemotherapy (irinotecan or paclitaxel). Patients treated with Enhertu had a 40% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio of 0.60; 95% confidence interval: 0.42-0.86, p=0.01) with a median OS of 12.5 months versus 8.9 months. Additionally, confirmed ORR, a major efficacy outcome, was 42.0% with Enhertu versus 12.5% with chemotherapy as assessed by ICR. The primary analysis was published in The New England Journal of Medicine,2 with the updated data presented at the 2021 American Society of Clinical Oncology Annual Meeting.

In both trials, the safety profiles observed in patients treated with Enhertu were consistent with those seen in other trials of Enhertu with no new safety signals identified.

Enhertu is approved in the US and several other countries for locally advanced or metastatic HER2-positive gastric cancer.

Photo of Susan Galbraith: AstraZeneca

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