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

Female patients with HER2+ unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Part 1, established the recommended phase 2 dose (RP2D). Part 2, Evaluated safety and efficacy at RP2D. 184 patients received ENHERTU 5.5 mg/kg. Administered by IV infusion. Q3W until unacceptable toxicity or disease progression. Female patients with HER2+ unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Part 1, established the recommended phase 2 dose (RP2D). Part 2, Evaluated safety and efficacy at RP2D. 184 patients received ENHERTU 5.5 mg/kg. Administered by IV infusion. Q3W until unacceptable toxicity or disease progression.
  • 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 72.2%
Female 27.8%
Race White 87.3%
Black or African American 1.3%
Asian 5.1%
Other 5.1%
Missing 1.3%
ECOG PS 0 36.7%
1 63.3%
Primary tumor site Gastric 34.2%
Gastroesophageal junction 65.8%
Histological subtype Adenocarcinoma 98.7%
Intestinal 24.1%
Diffuse 1.3%
Mixed 1.3%
Unknown 72.2%
Number of prior regimens 0 7.6%
1 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

  • 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.17

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
Weight decreased 34.2 2.5
Decreased appetite 32.9 5.1
Constipation 26.6 0
Alopecia 24.1 0
Abdominal pain 16.5 2.5
Platelet count decreased 16.5 2.5
Neutrophil count decreased 15.2 7.6
Asthenia 15.2 1.3
Hypokalemia 15.2 1.3
Aspartate aminotransferase increased 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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