AZ, Daiichi Sankyo’s Enhertu wins US approval for HER2-positive gastric cancer

AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval in the US for the treatment of locally advanced/metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval will make Enhertu available to adult patients with these cancer types who have received a prior trastuzumab-based regimen.

The US Food and Drug Administration (FDA) approval is based on results from the Phase III DESTINY-Gastric01 trial.

This study evaluated Enhertu versus chemotherapy  (irinotecan or paclitaxel) in patients with advanced gastric cancer or GEJ who had progressed on at least two or more prior regimens.

In this trial, patients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy, with median overall survival of 12.5 months versus 8.4 months.

Results also showed a confirmed overall response rate (ORR) of 40.5% in patients treated with Enhertu compared to 11.3% for patents treated with chemotherapy.

Patients treated with Enhertu had a 7.9% complete response rate and a 32.5% partial response rate compared to a complete response rate of 0% and a partial response rate of 11.3% for patients treated with chemotherapy.

“Today’s approval of Enhertu represents the first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer,” said Dave Fredrickson, executive vice president, oncology business unit at AZ.

“The results from the DESTINY-Gastric01 trial highlight the potential to change clinical practice, showing a 41% improvement in survival and a response rate more than three times higher with Enhertu compared to chemotherapy. We are thrilled to bring this important medicine to more patients and physicians in the US,” he added.