3 approved indications. 1 legacy. 1
7 Phase II or III clinical trials evaluated the efficacy, safety, and
tolerability of Herceptin1,6-15
Based on a report, 2.3 million patients worldwide were treated with Herceptin to date16
Adjuvant Breast Cancer 1
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
-
As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
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With docetaxel and carboplatin
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As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.
*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Herceptin was studied as adjuvant treatment in 4 pivotal trials involving more than 10,000 people with HER2+ breast cancer. 1
The primary endpoint was DFS, defined as the time from randomization to recurrence, occurrence of contralateral breast cancer, other second primary cancer, or death.
Studies in adjuvant breast cancer
Studies 1 and 2
†In NCCTG N9831, there was a sequential third arm that
was not analyzed as part of the joint analysis. The data from both
arms in Study 1 and two of the three study arms in Study 2 were
pooled for efficacy analyses.
7
AC=doxorubicin plus cyclophosphamide, TH=paclitaxel plus
Herceptin, T=paclitaxel.
Study summary 1,6-8
- An analysis of 3,752 patients from 2 multicenter, randomized, Phase III clinical trials conducted in patients with early breast cancer to evaluate the efficacy and safety of adding 1 year of Herceptin to adjuvant chemotherapy in the treatment of HER2+ early breast cancer
Primary endpoint 1
- The primary endpoint of the joint analysis was DFS, defined as time from randomization to recurrence, to occurrence of contralateral breast cancer, other second primary cancer, or death
The most common adverse reactions (≥5%) of Herceptin in adjuvant breast cancer are headache, diarrhea, nausea, and chills. 1
Herceptin treatment was permanently discontinued in patients who developed congestive heart failure, or persistent/recurrent LVEF decline. Radiation therapy, if administered, was initiated after the completion of chemotherapy. Patients with ER+ and/or PR+ tumors received hormonal therapy (as appropriate). 1
Study 3
Study summary 1,9
- An international, multicenter, randomized, Phase III, open-label, multi-modality controlled clinical trial was conducted in 5081 patients with early breast cancer to evaluate the effect of 1 and 2 years of every 3-week Herceptin treatment vs observation in the adjuvant treatment of HER2+ breast cancer
Primary endpoint 1
- The main outcome measure was DFS
The most common adverse reactions (≥5%) of Herceptin in adjuvant breast cancer are headache, diarrhea, nausea, and chills. 1
Patients with ER+ and/or PR+ disease received systemic adjuvant hormonal therapy at investigator discretion. 1
Study 4
TCH=docetaxel and carboplatin plus Herceptin, AC=doxorubicin plus cyclophosphamide, TH=docetaxel plus Herceptin, T=docetaxel.
Study summary 1,10,11
- An international, randomized, Phase III clinical trial was conducted in 3222 patients with early breast cancer to evaluate the efficacy and safety of adding 1 year of Herceptin to both an anthracycline-based and a non-anthracycline-containing adjuvant chemotherapy regimen
Primary endpoint 1
- The main outcome measure was DFS
The most common adverse reactions (≥5%) of Herceptin in adjuvant breast cancer are headache, diarrhea, nausea, and chills. 1
Patients with ER+ and/or PR+ disease received systemic adjuvant hormonal therapy at investigator discretion. 1
Metastatic Breast Cancer 1
Herceptin is indicated:
-
In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
-
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.
Herceptin was studied in 2 pivotal trials involving more than 600 people with HER2+ metastatic breast cancer. 1
The primary endpoint was median TTP in one trial and ORR in the other trial.
Studies in metastatic breast cancer
Study 5
Chemotherapy consisted of paclitaxel (175 mg/m2 over 3 hours every 21 days for at least 6 cycles); for all other patients, chemotherapy consisted of anthracycline plus cyclophosphamide (AC: doxorubicin 60 mg/m2 or epirubicin 75 mg/m2 plus 600 mg/m2 cyclophosphamide every 21 days for 6 cycles). 1
Study summary 1,12,13
- An international, randomized, Phase III, open-label, clinical trial was conducted in 469 patients with metastatic breast cancer evaluating the safety and efficacy of Herceptin monotherapy in treatment of women with metastatic breast cancer who had not previously been treated with chemotherapy for their metastatic disease
Primary endpoint 1
- The primary endpoint was median TTP
The most common adverse reactions (≥10%) of Herceptin in metastatic breast cancer are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. 1
Study 6
Study summary 1,14
- An international, Phase II, open-label, single-arm clinical trial was conducted in 222 patients with metastatic breast cancer to evaluate the safety and efficacy of Herceptin monotherapy in people with HER2 overexpressing metastatic breast cancer who had relapsed following 1 or 2 prior chemotherapy regimens for metastatic disease
Primary endpoint 1
- The main outcome measure was ORR, defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity
The most common adverse reactions (≥10%) of Herceptin in metastatic breast cancer are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. 1
Metastatic Gastric/GEJ Cancer 1
Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.
Herceptin was studied in 1 pivotal trial involving 594 people with HER2+ metastatic gastric cancer. 1
The primary endpoint was OS.
Studies in metastatic gastric cancer
Study 7
Study summary 1,15
- An international, randomized, Phase III, open-label clinical trial was conducted in 594 patients with metastatic gastric cancer to evaluate the safety and efficacy of Herceptin in combination with cisplatin and a fluoropyrimidine in patients previously untreated for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Primary endpoint 1
- The main outcome measure was OS
The most common adverse reactions (≥10%) of Herceptin in metastatic gastric cancer are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. 1
Across approved indications, Herceptin has been used to treat more than 2.3 million patients to date 16
Drug utilization assumptions were considered in order to calculate the number of patients exposed to Herceptin by indication worldwide, including US and Japan.
Patients treated is based on the PBRER report of patient exposure, which was calculated based on the global total milligram volume sales divided by the average dose per patient per year, based on US approved indications.
Average dose per patient was based on an average patient weight multiplied by mean dose divided by average treatment duration. Assumption of patient exposures from PBRER report may not necessarily correspond to a unique patient.
Excluding Japan, the average body weight was sourced from internal data sources ex-US and ranged between 65-75 kg in the US. Average dose was based on the approved dose of each indication. Note: Some dose interruptions may have been accounted for per clinician discretion. In Japan, total dose for each given indication was sourced from sales assumption data during that year and dose per patient per indication was sourced from 2014 sales assumption data.
PBRER=Periodic Benefit-Risk Evaluation Report.
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