FOCUS ON CLINICAL

EVIDENCE

OGIVRI has achieved all the benchmarks for biosimilarity in
efficacy and safety to Herceptin®.1-3

EFFICACY

The HERITAGE trial was a confirmatory, double-blind, Phase 3 equivalence trial comparing the efficacy and safety of OGIVRI to Herceptin in 500 adult patients with HER2+ metastatic breast cancer.1

Chart illustrating the study design for the HERITAGE trial
Chart illustrating the study design for the HERITAGE trial

*OGIVRI dosed at 8 mg/kg IV loading dose followed by 6 mg/kg IV Q3W. Docetaxel or paclitaxel selected by physician’s choice.

Study Endpoints

    • Primary endpoint: ORR (complete and partial response) at Week 241
    • Other endpoints included adverse events, LVEF, and immunogenicity at Week 24 and Week 48, and PFS and OS at Month 361

Baseline Characteristics 

    • Demographic, disease, and baseline characteristics were similar between treatment groups with no clinically relevant differences observed1

IV=intravenous; LVEF=left ventricular ejection fraction; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; Q3W=every 3 weeks; R=randomized.

  • Primary endpoint met: there were no significant differences in ORR at 
Week 24 between treatment groups1
  • 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*1

*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%.

  • Primary endpoint met: there were no significant differences in ORR at 
Week 24 between treatment groups1
  • 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*1

*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%. 

Bar chart comparing Ogivri and Herceptin ORR at week 24

Findings in the Heritage trial are comparable to other recent multicenter studies of trastuzumab + taxane in HER2+ patients.4

CI=confidence interval; ORR=overall response rate.

There were no statistically significant differences in PFS at 36 months between treatment groups.2

Line graph comparing PFS (progression-free survival) for Ogivri and Herceptin
Data table comparing Ogivri and Herceptin showing median PFS (progression-free survival) and Unstratified HR (hazard ratio)

CI=confidence interval; HR=hazard ratio; PFS=progression-free survival.

There were no statistically significant differences in OS at 36 months between treatment groups.2

Line graph comparing OS (overall survival) for Ogivri and Herceptin

CI=confidence interval; HR=hazard ratio; OS=overall survival.

SAFETY

Rates of treatment-emergent adverse events (TEAEs) were similar between the OGIVRI and Herceptin groups at Week 24.1

All grade TEAEs by Week 24 in the overall safety population (≥ 10% in either group).1

Data chart comparing safety data between Ogivri and Herceptin

CTCAE=common terminology criteria for adverse event.

There was no statistically significant difference in median LVEF between the 2 treatment groups at Week 24 
(safety population).1

Bar chart demonstrating difference in median LVEF between Ogivri and Herceptin

THE OVERALL ANTIDRUG ANTIBODY RATE WAS1:

  • 2.4% for OGIVRI + taxane
  • 2.8% for Herceptin

LVEF=left ventricular ejection fraction.

There were no statistically significant differences in all grade TEAEs between treatment groups in patients who continued on monotherapy (10% in either group).*2

chart

*Safety data are cumulative from start of monotherapy at Week 24 through 36 months of follow-up from the last patient on study.

TEAE=treatment-emergent adverse event.

REFERENCES

1. Rugo HS, Barve A, Waller CF, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 2017;317(1):37-47. 2. Rugo HS, Pennella EJ, Gopalakrishnan U, et al. Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Res Treat. 2021;188(2):369-377. 3. OGIVRI. Prescribing information. Biocon Biologics Inc; 2024. 4. Burstein HJ, Schrag D. Biosimilar therapy for ERBB2 (HER2)-positive breast cancer: close enough? JAMA. 2017;317(1):30-32.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

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

Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab 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 trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. 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 anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

Exposure to trastuzumab products 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 are 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

  • Adjuvant Breast Cancer: Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
  • Metastatic Breast Cancer: Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
  • Metastatic Gastric Cancer: Most common adverse reactions (≥ 10%) 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 in adults 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 consisting of doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • As part of a treatment regimen 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 a trastuzumab product.

*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 adults:

  • In combination with paclitaxel for 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 a trastuzumab product.

Metastatic Gastric Cancer 

OGIVRI is indicated in adults, 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 a trastuzumab product.

You may report side effects to the 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including BOXED WARNING.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

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

Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab 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 trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. 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 anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

Exposure to trastuzumab products 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 are 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

  • Adjuvant Breast Cancer: Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
  • Metastatic Breast Cancer: Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
  • Metastatic Gastric Cancer: Most common adverse reactions (≥ 10%) 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 in adults 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 consisting of doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • As part of a treatment regimen 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 a trastuzumab product.

*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 adults:

  • In combination with paclitaxel for 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 a trastuzumab product.

Metastatic Gastric Cancer

OGIVRI is indicated in adults, 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 a trastuzumab product.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including BOXED WARNING.

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INDICATIONS

Adjuvant Breast Cancer

Adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer2:

  • As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • As part of a treatment regimen with docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Metastatic Breast Cancer

  • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer2
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease2

Metastatic Gastric Cancer

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.2

For all indications, select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.2

*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. ER=estrogen receptor; HER2=human epidermal growth factor receptor 2; ORR=overall response rate; OS=overall survival; PR=progesterone receptor.