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
ENHERTU
(n=125)
All Grades
(%)
Grade 3 or 4
(%)
Irinotecan or Paclitaxel
(n=62)
All Grades
(%)
Grade 3 or 4
(%)
Gastrointestinal Disorders
Nausea
Diarrhea
Vomiting
Constipation
Abdominal paina
Stomatitisb
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
Dehydration
60 17
6 2.4
45 13
3.2 1.6
Blood and Lymphatic System Disorders
Anemiac
Febrile neutropenia
58 38
4.8 4.8
31 23
3.2 3.2
General Disorders and Administration Site Conditions
Fatigued
Pyrexia
Edema peripheral
22 8
24 0
10 0
29 4.8
16 0
0 0
Skin and Subcutaneous Tissue Disorders
Alopecia
22 0
15 0
Respiratory, Thoracic and Mediastinal Disorders
Interstitial lung diseasee
10 2.4
0 0
Hepatobiliary Disorders
Hepatic function abnormal
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, abdominal pain lower, and abdominal pain upper.

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, hemoglobin decreased, red blood cell count decreased, and hematocrit decreased.

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
ENHERTU
(n=125)
All Grades
(%)
Grade 3 or 4
(%)
Irinotecan or Paclitaxel
(n=62)
All Grades
(%)
Grade 3 or 4
(%)
Hematology
Hemoglobin decreased
White blood cell count decreased
Neutrophil count decreased
Lymphocyte count decreased
Platelet count decreased
75 38
74 29
72 51
70 28
68 12
55 23
53 13
45 23
53 12
12 5
Chemistry
Aspartate aminotransferase increased
Blood alkaline phosphatase increased
Alanine aminotransferase increased
Hypokalemia
Blood bilirubin increased
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%)

Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor patients and initiate management at first sign of ILD1*

Learn More About the Potential Risks of Treatment

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

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