AstraZeneca Investor Day Presentation Deck
Enhertu: DESTINY-Gastric02 trial design
Open-label, multicentre Phase II trial in Western patients with HER2+ gastric or
GEJ cancer (NCT04014075)
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Key eligibility criteria
Pathologically documented, unresectable
or metastatic gastric or GEJ cancer
Centrally confirmed HER2 positive disease
(defined as IHC 3+ or IHC 2+/ISH+) on
biopsy after progression on first-line
trastuzumab-containing regimen
• ECOG PS 0 or 1
T-DXd
6.4 mg/kg Q3W
N = 79¹
Primary endpoint
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Secondary endpoints²
PFS by ICR
OS
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Confirmed ORR by ICR
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DOR by ICR
Safety and tolerability
DESTINY-Gastric02 is the first study focused only on second-line T-DXd monotherapy in Western patients with HER2+ gastric/GEJ
cancer who have progressed on a trastuzumab-containing regimen
It is the follow-on study to DESTINY-Gastric01, which evaluated T-DXd third-line or later in Asian patients³
Patients were enrolled in Europe (Belgium, Great Britain, Italy, Spain) and the United States (data cutoff: April 9, 2021)
1. Enrollment of 80 patients was planned; actual enrollment was 79 patients 2. Other secondary endpoints were ORR, PFS, and DOR by investigator assessment, pharmacokinetics, anti-drug antibodies, and patient-reported
outcomes 3. Shitara K et al. N Engl J Med. 2020;382:2419-30.
31 GEJ = gastroesophageal junction; ISH = in situ hybridisation.
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