Enhertu Receives FDA Approval for Gastroesophageal, Gastric Cancer Subset

The Food and Drug Administration (FDA) approved Enhertu (fam-trastuzumab deruxtecan-nxki) to treat adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal cancer who have previously received a trastuzumab-based treatment regimen, according to the agency.

The decision was based on data from the multicenter DESTINY-Gastric01 trial.

In the DESTINY-Gastric01 trial, 126 patients were randomized to receive Enhertu intravenously every three weeks or provider’s choice of either the chemotherapy irinotecan or the chemotherapy paclitaxel. Patients presented with HER2-positive locally advanced or metastatic gastric or gastroesophageal cancer and their disease had progressed after receiving at least two previous treatment regimens, including trastuzumab, as well as a fluoropyrimidine- and a platinum-containing chemotherapy.

Measuring overall survival and objective response rate (the proportion of patients who had a complete or partial response to treatment) served as the main goal of the study. Additional study end points included progression-free survival (the time from treatment to disease worsening) and duration of response to therapy.

Patients in the Enhertu arm achieved a median overall survival of 12.5 months, compared to 8.4 months in those who received physician’s choice of therapy. The objective response rate was 40.5% in those who received the trial drug, versus 11.3% in patients who were administered either irinotecan or paclitaxel. The median duration of response was significantly higher in the Enhertu arm (11.3 months), compared to the physician’s choice arm (3.9 months).

Enhertu also induced a longer median progression-free survival (5.6 months), compared to irinotecan or paclitaxel (3.5 months).

The most common side effects to occur in more than 20% of the patient population included, but were not limited to, nausea, decreased appetite, fatigue, diarrhea, vomiting, constipation and alopecia.

There is a boxed warning with this approval for health care professionals to be aware of the risks of interstitial lung disease and embryo-fetal toxicity.