DESTINY-Gastric01 Trial

ENHERTU was approved based on DESTINY-Gastric01

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

Study design for DESTINY-Gastric01. 188 adult patients in Japan and South Korea with HER2+ locally advanced or metastatic gastric or GEJ adenocarcinoma who had progressed on ≥2 prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy regimen were randomized to receive ENHERTU 6.4 mg/kg once every 3 weeks (n=126) or physician’s choice of irinotecan (n=56) or paclitaxel (n=7). Patients were treated until unacceptable toxicity or disease progression. Study design for DESTINY-Gastric01. 188 adult patients in Japan and South Korea with HER2+ locally advanced or metastatic gastric or GEJ adenocarcinoma who had progressed on ≥2 prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy regimen were randomized to receive ENHERTU 6.4 mg/kg once every 3 weeks (n=126) or physician’s choice of irinotecan (n=56) or paclitaxel (n=7). Patients were treated until unacceptable toxicity or disease progression.
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 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%
Select Patient Characteristics ENHERTU
(n=126)
Irinotecan or
Paclitaxel
(n=62)
Median aged 65.5 66.0
Sex Male 76.2% 23.8%
Female 75.8% 24.2%
ECOG PSe 0 49.2% 50.0%
1 48.4% 51.6%
Primary tumor site Gastric 86.5% 13.5%
Gastroesophageal junction 88.7% 11.3%
Histo-logical subtype Intestinal 70.6% 61.3%
Diffuse 23.0% 29.0%
Other 6.3% 9.7%
For gastric and gastro-eso-phageal junction cancer Inoperable advanced 61.1% 74.2%
Postoperative recurrent 38.9% 25.8%
Presence of metastasis Liver 54.0% 54.8%
Lung 31.0% 24.2%
Prior lines of systemic therapy for advanced or metastatic diseasef 2 52.4% 61.3%
≥3 47.6% 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 one 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

Ready to learn more about ENHERTU?

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