DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Summary
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Timeline
- Start
- 2017-11-02
- Primary completion
- 2019-11-08
- Completion
- 2020-12-11
Outcome
Met primary endpoint
paper 51% of the patients in the trastuzumab deruxtecan group, as compared with 14% of those in the physician's choice group (P<0.001). PMID 32469182 ↗
release “DESTINY-Gastric01 showed AstraZeneca’s and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan), achieved a statistically significant and clinically meaningful improvement in objective response rate” astrazeneca.com ↗
release “Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint” daiichisankyo.com ↗
release “In DESTINY-Gastric01, the response rate was more than three times higher with Enhertu versus chemotherapy.” astrazeneca.com ↗
release “In DESTINY-Gastric01, the response rate was more than three times higher with ENHERTU versus chemotherapy.” daiichisankyo.com ↗
release “DESTINY-Gastric01 randomised Phase II trial, which demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint” astrazeneca.com ↗
Publications
- Results Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.
- Kapil A, Failmezger H, Fu Y, Spitzmuller A, Chan J, Haneder S, Shumilov A, Barkell A, Oguma T, Inaki K, Suto F, Allard J, Lee J, Lambert AW, Schick M, Barrett JC, Schmidt G, Sade H, Gustavson M, Carroll D, Cecchi F. Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan-Treated Human Epidermal Growth Factor Receptor 2-Positive Gastric Cancer. JCO Precis Oncol. 2026 May;10(5):e2500823. doi: 10.1200/PO-25-00823. Epub 2026 May 28.
- Yamaguchi K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Shimoyama T, Lee KW, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Shitara K. Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial. J Clin Oncol. 2023 Feb 1;41(4):816-825. doi: 10.1200/JCO.22.00575. Epub 2022 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | 150 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 6.4 mg/kg | Intravenous |