DESTINY-Gastric01 Trial

ENHERTU was approved based on DESTINY-Gastric01

A Phase 2, multicenter, open-label, randomized trial1,2

Adult patients in Japan and Korea with HER2-expressing, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma given ENHERTU® (fam-trastuzumab deruxtecan-nxki) or irinotecan or paclitaxel. Adult patients in Japan and Korea with HER2-expressing, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma given ENHERTU® (fam-trastuzumab deruxtecan-nxki) or irinotecan or paclitaxel.
Major efficacy outcomes1 Additional efficacy outcomes1,2
  • Objective response rate (ORR), based on an independent central review (ICR) and overall survival (OS)
  • Progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR)
Major efficacy outcomes1
  • Objective response rate (ORR), based on an independent central review (ICR), and overall survival (OS)
Additional efficacy outcomes1,2
  • Progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR)
Key exclusion criteria1,3
  • History of treated ILD/pneumonitis or current ILD/pneumonitis at screening
  • Current pleural effusion, ascites, or pericardial effusion
  • History of clinically significant cardiac disease
  • ECOG performance status >1
  • Clinically active brain metastases
  • History of treated ILD/pneumonitis or current ILD/pneumonitis at screening
  • History of clinically significant cardiac disease
  • Clinically active brain metastases
  • Current pleural effusion, ascites, or pericardial effusion
  • ECOG performance status >1

aA total of 30% of patients were identified as HER2-positive using tissue obtained following prior treatment with trastuzumab, while the remaining 70% were identified as HER2-positive using tissue obtained before trastuzumab treatment.1

bIntent-to-treat population.

In DESTINY-Gastric01,

Baseline patient characteristics were similar between treatment arms3,c

Select patient characteristics ENHERTU
(n=126)
Irinotecan or
Paclitaxel
(n=62)
Median aged 65.5 66.0
Sex
Male
Female
76.2%
23.8%
75.8%
24.2%
ECOG PSe
0
1
49.2%
50.0%
48.4%
51.6%
Primary tumor site
Gastric
Gastroesophageal junction
86.5%
13.5%
88.7%
11.3%
Histological subtype
Intestinal
Diffuse
Other
70.6%
23.0%
6.3%
61.3%
29.0%
9.7%
For gastric and gastro-esophageal junction cancer
Inoperable advanced
Postoperative recurrent
61.1%
38.9%
74.2%
25.8%
Presence of metastasis
Liver
Lung
54.0%
31.0%
54.8%
24.2%
Prior lines of systemic therapy for advanced or metastatic diseasef
2
≥3
52.4%
47.6%
61.3%
38.7%

cBaseline is defined as the last nonmissing value taken before the first dose of the study drug.3

dMedian age at informed consent.3

eECOG PS was missing for 1 patient in the ENHERTU arm.3

fTherapies intended to treat locally advanced/metastatic or neo-adjuvant or adjuvant disease if progressive disease within 6 months since the end of therapy.3

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ECOG PS, Eastern Cooperative Oncology Group performance status; HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; IHC, immunohistochemistry; ISH, in situ hybridization.