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  • Study Design: The Heritage Trial

    The HERITAGE trial: Designed per FDA guidelines to detect any potentially clinically meaningful difference between Ogivri® and reference trastuzumab9

    A confirmatory, double-blind, phase 3 equivalence trial in patients with HER2+ metastatic breast cancer10

    Study Endpoints
    • Primary endpoint was week 24 ORR (complete and partial response )10
    • Other endpoints included adverse events, LVEF, and immunogenicity at week 24 and 48 and PFS and OS at month 36 2,10
    Baseline Characteristics
    • Demographic, disease, and baseline characteristics were similar between treatment groups with no clinically relevant differences observed.10
    The Heritage Study experience… could serve as a blueprint for development of other biosimilar products.11
    LVEF: Left ventricular ejection fraction; ORR: Overall response rate; OS: Overall survival; PFS: Progression-free survival
  • Statistical therapeutic equivalence in ORR at 24 weeks10

    Primary end point of ORR met at 24 weeks.

    ORR ratio (1.09; 90% CI: 0.974–1.211) and ORR difference (5.53; 95% CI: −3.08–14.04) were within the defined equivalence boundaries*

    *ORR ratio 90% CI equivalence boundaries were defined as 0.81 to 1.24 and ORR difference equivalence boundaries were defined as -15% and 15%.
    Findings in the HERITAGE Trial are comparable to other recent multicenter studies of trastuzumab + taxane in HER2+ patients.11

    CI: Confidence interval; ORR: Overall response rate

  • First FDA-approved trastuzumab biosimilar with PFS at 36 months

    No significant differences in PFS to reference trastuzumab at 36 months

    Efficacy

    Ogivri®(n=230) Reference trastuzumab (n=228)
    Median PFS 11.1 11.1
    Unstratified HR (95 % CI) 0.98 (0.78-1.24)

    CI: Confidence interval; HR: Hazard ratio; ITT1: Intention-to–treat-1; PFS: Progression-free survival

  • First FDA-approved trastuzumab biosimilar with OS at 36 months

    No significant differences in OS to reference trastuzumab at 36 months

    Efficacy
    Ogivri®(n=230) Reference trastuzumab (n=228)
    Number of events 109 114
    Median OS 35.0 30.2
    HR (95 % CI) 0.90 (0.69-1.17)
    CI: Confidence interval; OS: Overall survival

IMPORTANT SAFETY INFORMATION

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WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

  • Administration of Ogivri can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Ogivri with anthracycline-containing chemotherapy regimens.
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

  • Administration of Ogivri can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Ogivri with anthracycline-containing chemotherapy regimens.
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion Reactions; Pulmonary Toxicity

  • Administration of Ogivri can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt Ogivri infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

  • Exposure to Ogivri during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

Cardiomyopathy

  • Ogivri administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Ogivri with anthracycline-containing chemotherapy regimens
  • Ogivri can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Ogivri can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri
  • Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions

  • Ogivri administration can result in serious and fatal infusion reactions
  • Symptoms usually occur during or within 24 hours of Ogivri administration
  • Interrupt Ogivri infusion for dyspnea or clinically significant hypotension
  • Monitor patients until symptoms completely resolve
  • Discontinue Ogivri for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
  • Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

Embryo-Fetal Toxicity

  • Exposure to Ogivri during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of Ogivri
  • Advise pregnant women and females of reproductive potential that exposure to Ogivri during pregnancy or within 7 months prior to conception can result in fetal harm
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of Ogivri. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ogivri treatment and any potential adverse effects on the breastfed child from Ogivri or from the underlying maternal condition

Pulmonary Toxicity

  • Ogivri administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
  • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
  • Discontinue Ogivri in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

  • The most common adverse reactions associated with Ogivri in breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
  • The most common adverse reactions associated with Ogivri in metastatic gastric cancer are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

INDICATIONS

Adjuvant Breast Cancer

Ogivri® 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
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for Ogivri.

* 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>

Metastatic Breast Cancer

Ogivri 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 Ogivri.

Metastatic Gastric Cancer

Ogivri is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for Ogivri.