Enhertu Snags FDA Approval for HER2-Positive Gastric Cancer Patients

Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has become the first HER2-directed medication approved to treat gastric cancer in the U.S. in 10 years.

This morning, Daiichi Sankyo announced the U.S. Food and Drug Administration gave the green light to Enhertu for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu, an antibody-drug conjugate (ADC) comprised of a humanized anti-HER2 IgG1 monoclonal antibody was previously approved as a treatment for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.  

Approval in gastric cancer, which is typically diagnosed in the advanced stages, was based on positive results from the Phase II DESTINT-Gastric01 study. In that trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective response rate (ORR) versus chemotherapy in patients with advanced gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens including trastuzumab, a fluoropyrimidine and a platinum-containing chemotherapy.

In the study, Enhertu-treated patients had a 41% reduction in the risk of death versus chemotherapy-treated patients. At a pre-specified interim analysis, those patients treated with Enhertu demonstrated a median OS of 12.5 months compared to 8.4 months with chemotherapy. Trial results also showed a confirmed ORR of 40.5% with Enhertu compared to 11.3% 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.

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