AstraZeneca and Daiichi Sankyo’s Enhertu recommended for approval

colon cancer diagnostics haliodx 1

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) for patients previously treated HER-2 positive advanced gastric cancer.

The drug is also used for gastroesophageal junction (GEJ) 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.

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 2 trials.

Updated results

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 2 trial were presented at the 2021 European Society for Medical Oncology (ESMO) Congress, with the updated data presented at ESMO 2022.

In DESTINY-Gastric01, conducted in patients from Japan and South Korea, updated results showed treatment with Enhertu resulted 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 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, with the updated data presented at the 2021 American Society of Clinical Oncology annual meeting.

Susan Galbraith, executive vice president, oncology research and development at AstraZeneca, said: “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.”

Enhertu demonstrates significant improvement

Ken Takeshita, global head, oncology R&D, Daiichi Sankyo, Inc, said: “Enhertu is the first HER2-directed medicine to demonstrate a significant improvement in overall survival compared to chemotherapy in patients with gastric cancer following initial treatment with a HER2-directed medicine in the advanced or metastatic setting. The CHMP opinion recognizes the high unmet need in this patient population and brings us one step closer to bringing this medicine to patients with gastric cancer in Europe.”

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 U.S. and several other countries for locally advanced or metastatic HER2-positive gastric cancer.

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