Safety Data

ENHERTU has serious Warnings and Precautions. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

ENHERTU safety in DESTINY-Gastric01

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma in DESTINY-Gastric01.1
  • Patients received intravenously at least 1 dose of either ENHERTU (n=125) 6.4 mg/kg once every 3 weeks or physician’s choice of chemotherapy: either irinotecan (n=55) 150 mg/m2 biweekly or paclitaxel (n=7) 80 mg/m2 weekly for 3 weeks1
  • The median duration of treatment was 4.6 months (range: 0.7-22.3) in ENHERTU-treated patients and 2.8 months (range: 0.5-13.1) in irinotecan/paclitaxel patients1
  • In the clinical trial, prophylactic or supportive treatment of ENHERTU-induced adverse events was not mandated and was per investigator’s discretion and institutional guidelines, eg, granulocyte colony-stimulating factor was allowed per protocol for prophylaxis or treatment and antiemetics were allowed for prophylactic treatment5

Adverse reactions in ≥10% all Grades or ≥2% Grades 3 or 4 of patients receiving ENHERTU in DESTINY-Gastric011

Adverse reactions
All Grades
Grade 3 or 4
Irinotecan or Paclitaxel
All Grades
Grade 3 or 4
Gastrointestinal disorders
Abdominal paina
63 4.8
32 2.4
26 0
24 0
14 0.8
11 1.6
47 1.6
32 1.6
8 0
23 0
15 3.2
4.8 0
Metabolism and nutritional disorders
Decreased appetite
60 17
6 2.4
45 13
3.2 1.6
Blood and lymphatic system disorders
Febrile neutropenia
58 38
4.8 4.8
31 23
3.2 3.2
General disorders and administration site conditions
Peripheral edema
55 9
24 0
10 0
44 4.8
16 0
0 0
Skin and subcutaneous tissue disorders
22 0
15 0
Respiratory, thoracic and mediastinal disorders
Interstitial lung diseasee
10 2.4
0 0
Hepatobiliary disorders
Abnormal hepatic function
8 3.2
1.6 1.6

Events were graded using NCI-CTCAE version 4.03. N=number of patients exposed; PT=preferred term.

Percentages were calculated using the number of patients in the Safety Analysis Set (N=187) as the denominator.

aGrouped term of abdominal pain includes PTs of abdominal discomfort, gastrointestinal pain, abdominal pain, lower abdominal pain, and upper abdominal pain.

bGrouped term of stomatitis includes PTs of stomatitis, aphthous ulcer, mouth ulceration, oral mucosa erosion, and oral mucosal blistering.

cGrouped term of anemia includes PTs of anemia, decreased hemoglobin, decreased red blood cell count, and decreased hematocrit.

dGrouped term of fatigue includes PTs of fatigue, asthenia, and malaise.

eInterstitial lung disease includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, and alveolitis.

  • Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg1
  • Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage1
Other clinically relevant adverse reactions reported in less than 10% of patients were:
  • Cardiac Disorders: asymptomatic left ventricular ejection fraction decrease (8%)
  • Infections and Infestations: pneumonia (6%)
  • Injury, Poisoning and Procedural Complications: infusion-related reactions (1.6%)

Selected laboratory abnormalities occurring in patients receiving ENHERTU in DESTINY-Gastric011

Laboratory parameter
All Grades
Grade 3 or 4
Irinotecan or Paclitaxel
All Grades
Grade 3 or 4
Decreased hemoglobin
Decreased white blood cell count
Decreased neutrophil count
Decreased lymphocyte count
Decreased platelet count
75 38
74 29
72 51
70 28
68 12
55 23
53 13
45 23
53 12
12 5
Increased aspartate aminotransferase
Increased blood alkaline phosphatase
Increased alanine aminotransferase
Increased blood bilirubin
58 9
54 8
47 9
30 4.8
24 7
32 8
34 10
17 1.7
18 8
5 3.4

Percentages were calculated using patients with worsening laboratory values from baseline and the number of patients with both baseline and post-treatment measurements as the denominator. Frequencies were based on NCI-CTCAE v.4.03 grade-derived laboratory abnormalities.

Adverse reactions may require dose discontinuation, interruption, or reduction1

    In patients treated with ENHERTU
  • Discontinuation occurred in 15% of patients, of which ILD accounted for 6%
  • Dose interruptions occurred in 62% due to adverse reactions
    • The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia
  • Dose reductions occurred in 32% of patients
    • The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia
    Fatalities due to adverse reactions occurred in 2.4% of patients1
  • Disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in 1 patient each (0.8%)

ILD and pneumonitis, including Grade 5 cases, have been reported with ENHERTU. Monitor patients and initiate management at first sign of ILD1,f,g

  • ILD and pneumonitis, including fatal cases, have been reported with ENHERTU
Learn More About the Potential Risks of Treatment

fILD includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis.1

g Grade 5=fatal cases.

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