publication date: Jan. 22, 2021

Drugs & Targets

Enhertu receives FDA approval for HER2-positive gastric adenocarcinomas

FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu is sponsored by Daiichi Sankyo.

Efficacy was evaluated in a multicenter, open-label, randomized trial (DESTINY-Gastric01, NCT03329690) in patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy. A total of 188 patients were randomized (2:1) to receive fam-trastuzumab deruxtecan-nxki 6.4 mg/kg intravenously every three weeks or physician’s choice of either irinotecan or paclitaxel monotherapy.

The main efficacy outcome measures were overall survival and objective response rate assessed by independent central review (RECIST 1.1) in the intent-to-treat population. Additional efficacy outcome measures were progression-free survival and duration of response.

OS was 12.5 months (95% CI: 9.6, 14.3) in the fam-trastuzumab deruxtecan-nxki arm compared with 8.4 months (95% CI: 6.9, 10.7) in the irinotecan or paclitaxel arm (HR 0.59; 95% CI: 0.39, 0.88, p=0.0097). Confirmed ORR was 40.5% (95% CI: 31.8, 49.6) in the fam-trastuzumab deruxtecan-nxki arm compared with 11.3% (95% CI: 4.7, 21.9) for those receiving irinotecan or paclitaxel.

Median PFS was 5.6 months (95% CI: 4.3, 6.9) in the fam-trastuzumab deruxtecan-nxki arm compared to median PFS of 3.5 months (95% CI: 2.0, 4.3) in the irinotecan or paclitaxel arm. Median DOR was 11.3 months (95% CI: 5.6, NR) vs. 3.9 months (95% CI: 3.0, 4.9), respectively.

 

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