DESTINY-Gastric02

ENHERTU was evaluated in a 2L trial in patients in the US and Europe with HER2+ advanced gastric or GEJ adenocarcinoma7

A multicenter, open-label, single-arm Phase 2 trial7,8

Adult patients in the United States, Italy, Great Britain, Belgium, and Spain with HER2+ unresectable or gastric or metastatic gastroesophageal junction adenocarcinoma given ENHERTU® (fam-trastuzumab deruxtecan-nxki). Adult patients in the United States, Italy, Great Britain, Belgium, and Spain with HER2+ unresectable or gastric or metastatic gastroesophageal junction adenocarcinoma given ENHERTU® (fam-trastuzumab deruxtecan-nxki).
  • Primary endpoint was confirmed ORR assessed by ICR and secondary endpoints included PFS assessed by ICR, OS, DOR by ICR, and safety and tolerability7
Select patient characteristics ENHERTU
(n=79)
Median age 60.7 (20.3,77.8)
Sex
Male
Female
72.2%
27.8%
Race
White
Black or African American
Asian
Other
Missing
87.3%
1.3%
5.1%
5.1%
1.3%
ECOG PS
0
1
36.7%
63.3%
Primary tumor site
Gastric
Gastroesophageal junction
34.2%
65.8%
Histological subtype
Adenocarcinoma
Intestinal
Diffuse
Mixed
Unknown
98.7%
24.1%
1.3%
1.3%
72.2%
Number of prior regimens
0
1
7.6%
92.4%

Data shown above for select patient characteristics may not equate to 100% due to rounding.

  • 6 patients received trastuzumab-containing regimen as intended for neoadjuvant, palliative, or maintenance therapy7

DESTINY-Gastric02 shows consistent efficacy and safety results with
DESTINY-Gastric011,7

Confirmed ORR: Primary endpoint

Bar chart depicting ENHERTU® (fam-trastuzumab deruxtecan-nxki) monotherapy confirmed objective response rate. Bar chart depicting ENHERTU® (fam-trastuzumab deruxtecan-nxki) monotherapy confirmed objective response rate.
  • Based on full analysis set

Median DOR: Secondary endpoint

8.1 months
(95% CI: 4.1, NE)

Based on responders (n=30); 21 patients were censoreda

aReasons for censoring included initiating new anticancer therapy, adequate tumor assessment no longer available, and ongoing without occurrence of progressive disease or death.7


Median PFS: Secondary endpoint

5.5 months
(95% CI: 4.2, 7.3)

Based on 42 events (36 PD, 6 deaths)

Most common TEAEs occurring in patients receiving ENHERTU in DESTINY-Gastric02 (N=79)7

Treatment-emergent
adverse events
All grades (%)
(>10% of patients)
Grade 3 or 4 (%)
Nausea 65.8 7.6
Vomiting 41.8 2.5
Fatigue 40.5 3.8
Anemia 34.2 13.9
Diarrhea 34.2 1.3
Decreased weight 34.2 2.5
Decreased appetite 32.9 5.1
Constipation 26.6 0
Alopecia 24.1 0
Abdominal pain 16.5 2.5
Decreased platelet count 16.5 2.5
Decreased neutrophil count 15.2 7.6
Asthenia 15.2 1.3
Hypokalemia 15.2 1.3
Increased aspartate aminotransferase 11.4 1.3
Gastroesophageal reflux disease 10.1 0
Neutropenia 10.1 7.6
Pyrexia 10.1 0
  • Median treatment duration with ENHERTU was 4.3 months (range, 0.7-15.9)7

ILD and pneumonitis, including Grade 5 cases, have been reported with ENHERTU; the majority in DESTINY-Gastric02 were Grade 1 or 2 (n=5/6 [ILD all Grades: 7.6%; N=79])7,b

  • ILD includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis1
  • ILD and pneumonitis, including fatal cases, have been reported with ENHERTU1
  Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Any Grade
n (%) 2 (2.5) 3 (3.8) 0 0 1 (1.3) 6 (7.6)

bGrade 5=fatal cases.
mPFS, median progression-free survival; TEAE, treatment-emergent adverse event.

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