DESTINY-Gastric01 — Trastuzumab Deruxtecan (T-DXd) Versus Chemotherapy in HER2-Positive Advanced Gastric or GEJ Adenocarcinoma (DESTINY-Gastric01)

Phase 2 · 2020 · Gastric Cancer

Design

Randomized, open-label trial of T-DXd vs physician's-choice chemotherapy (irinotecan or paclitaxel).

Population

HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma progressing after at least two prior regimens including trastuzumab (conducted in Japan and South Korea).

Primary Endpoint

objective response rate (ORR)

Key Result

ORR 51% vs 14%; median OS 12.5 vs 8.4 mo (HR 0.59, P=0.01).

Guideline Impact

FDA-approved 2021; NCCN-listed for HER2+ gastric/GEJ adenocarcinoma after prior trastuzumab