# DESTINY-Gastric01

Source: https://onco.cc/trials/destiny-gastric01/  
OnCo record `destiny-gastric01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

DESTINY-Gastric01 showed that trastuzumab deruxtecan shrank tumours far more often than standard chemotherapy, and helped people live longer, in HER2-positive stomach cancer that had already progressed on trastuzumab.

## Summary

DESTINY-Gastric01 was an open-label randomised phase 2 trial in Japan and South Korea. Patients with HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose disease had progressed after at least two regimens including trastuzumab were randomised two to one to trastuzumab deruxtecan or to the physician's choice of irinotecan or paclitaxel. The primary endpoint was objective response by independent review. Exploratory cohorts enrolled HER2-low tumours.

The response rate was substantially higher with trastuzumab deruxtecan and overall survival was longer than with chemotherapy. Interstitial lung disease and myelosuppression were the notable toxicities. The result led to approval in the United States in January 2021 for HER2-positive gastric cancer after a trastuzumab-based regimen, the first antibody-drug conjugate for the disease.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT03329690
- Phase: 2
- Setting: HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior regimens including trastuzumab: trastuzumab deruxtecan against physician's choice of irinotecan or paclitaxel
- Sponsor: Daiichi Sankyo
- Enrolled: 233
- Result: Higher objective response rate and longer overall survival with trastuzumab deruxtecan than with irinotecan or paclitaxel; approved in January 2021.

## Sources

- ClinicalTrials.gov NCT03329690: https://clinicaltrials.gov/study/NCT03329690

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/)
- drugs: [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Kohei Shitara](https://onco.cc/people/shitara-kohei/)
- key papers: [DESTINY-Gastric01: trastuzumab deruxtecan in previously treated HER2-positive gastric cancer](https://onco.cc/key-papers/paper-destiny-gastric01-nejm-2020/)

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