Indications
Adjuvant Breast Cancer

KANJINTI™ is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

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  • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • As part of treatment 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 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

KANJINTI™ 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 trastuzumab product.

Metastatic Gastric Cancer

KANJINTI™ 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 trastuzumab product.

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BEHIND KANJINTI™

A ROBUST BIOSIMILARS PROGRAM

The FDA approved KANJINTI™ as a biosimilar to Herceptin® WITH THE SAME INDICATIONS1,2

KANJINTI™ underwent rigorous evaluation to confirm that there were no clinically meaningful differences compared with Herceptin®.3-5

Biosimilar or Biosimilarity means there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.6

KANJINTI™ is highly similar to Herceptin® based on a totality of evidence3-5

BIOSIMILARITY PROVEN IN A COMPARATIVE CLINICAL STUDY3

KANJINTI™ is the first and only Herceptin® biosimilar with single‑transition study data in the early breast cancer (eBC) setting1‑3,7‑12

The LILAC study a comparative clinical study in HER2+ eBC
  • Study results demonstrated no clinically meaningful differences between KANJINTI™ and Herceptin®.3
  • eBC is a homogenous and sensitive population for assessing any clinically meaningful differences between the 2 products.3,13

THE COMPARATIVE CLINICAL STUDY INCLUDED A SINGLE TRANSITION3

Single transition
Designed to provide robust data by:
  • Reinforcing clinical similarity of KANJINTI™ and Herceptin®3
  • Replicating a real-world clinical scenario of transitioning patients from Herceptin® to KANJINTI™14
  • Providing safety and immunogenicity data for up to 1 year of treatment3

Similar safety and immunogenicity, EVEN IN patients who transitioned to KANJINTI™3

Transitioned to KANJINTI™
  • KANJINTI™ was proven similar to Herceptin® with no new or different adverse events.3
  • Antidrug antibody formation was low and consistent with Herceptin®, with no patients testing positive for neutralizing antibodies.3
  • No evidence of increased cardiotoxicity for KANJINTI™
    —changes in LVEF were similar between KANJINTI™ and Herceptin®.3
  • LVEF = left ventricular ejection fraction.

Bioequivalence shown in clinical pharmacokinetic studies

Pharmacokinetics were bioequivalent to Herceptin® in
healthy subjects4,5

Mean serum concentration-time profiles for Kanjinti™,
Herceptin® (US), and Herceptin® (EU) IN HUman Volunteers4
KANJINTI™ Pharmacokinetic –  Mean Serum Concentration-time ProfilesKANJINTI™ Pharmacokinetic –  Mean Serum Concentration-time Profiles

A randomized, single-blind, single-dose, 3-arm, parallel-group study to determine the pharmacokinetic equivalence of KANJINTI™ and Herceptin® in healthy adult males. The primary objective was to evaluate bioequivalence of KANJINTI™ and Herceptin® in terms of AUCinf and Cmax (equivalence criteria: 90% CI for geometric mean ratio within 0.80–1.25).

  • The mean serum concentration-time profiles were similar between treatments over the entire course of sampling.4
  • Peak concentrations were observed approximately 1.5 to 5 hours after the start of the infusion.4

AUCinf = area under the concentration curve versus time from zero to infinity; Cmax = maximum serum concentration;
CI = confidence interval; PK = pharmacokinetic.

Comparable nonclinical antitumor activity data
Similar antitumor activity to HERCEPTIN® in XENOGRAFT models5
Antitumor activity in breast cancer xenograft study
KANJINTI™ Nonclinical Data – Antitumor Activity in Breast Cancer Xenograft StudyKANJINTI™ Nonclinical Data – Antitumor Activity in Breast Cancer Xenograft Study

NOD/SCID mice were injected orthotopically with BT-474 human breast tumor cells that naturally overexpress HER2 receptors (8 x 106 cells per mouse). After 21 days, treatment with vehicle control, KANJINTI™, or Herceptin® was administered twice weekly by IV for 19 days. Tumor sizes were measured twice per week until day 56.

Antitumor activity in Gastric cancer xenograft study
KANJINTI™ Nonclinical Data – Antitumor Activity in Gastric Cancer Xenograft StudyKANJINTI™ Nonclinical Data – Antitumor Activity in Gastric Cancer Xenograft Study

CD-1 nude mice were injected subcutaneously with NCI‑N87 gastric tumor cells (5 x 106 cells per mouse). When average tumor size reached ~ 100 mm3, vehicle control, KANJINTI™, or Herceptin® was administered twice weekly by intraperitoneal injection for 19 days. Tumor sizes were measured three times per week until day 35.

BT-474 = metastatic human breast cancer cells; HER2 = human epidermal growth factor receptor 2; IV = intravenous; NCI‑N87 = human gastric cancer cells; NOD/SCID = nonobese diabetic/severe combined immune deficient.

Analytical (Foundational) Studies

Analytical data can be summarized as similar with regard to: DNA sequence, monoclonal antibody protein structure, biological activity, purity, and stability.15

Important Safety Information

Boxed WARNINGS: Cardiomyopathy-Trastuzumab products administration 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 KANJINTI™. Discontinue KANJINTI™ treatment in patients receiving adjuvant therapy and withhold KANJINTI™ in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions; Pulmonary Toxicity- Trastuzumab products administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt KANJINTI™ infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI™ 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

Additional Important Safety Information
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. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy
  • Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
  • Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF)
  • Discontinue KANJINTI™ treatment in patients receiving adjuvant breast cancer therapy and withhold KANJINTI™ in patients with metastatic disease for clinically significant decrease in left ventricular function
Cardiac Monitoring
  • Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of KANJINTI™
  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Monitor frequently for decreased left ventricular function during and after KANJINTI™ treatment
  • Monitor more frequently if KANJINTI™ is withheld for significant left ventricular cardiac dysfunction
Infusion Reactions
  • KANJINTI™ administration can result in serious and fatal infusion reactions
  • Symptoms usually occur during or within 24 hours of KANJINTI™ administration
  • Interrupt KANJINTI™ infusion for dyspnea or clinically significant hypotension
  • Monitor patients until symptoms completely resolve
  • Discontinue KANJINTI™ 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 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
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of KANJINTI™
  • Advise pregnant women and females of reproductive potential that exposure to KANJINTI™ 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 KANJINTI™. Advise female patients to contact their health care provider with a known or suspected pregnancy
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for KANJINTI™ treatment and any potential adverse effects on the breastfed child from KANJINTI™ or from the underlying maternal condition
Pulmonary Toxicity
  • Trastuzumab products 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 KANJINTI™ 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 trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
  • The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.


INDICATIONS
Adjuvant Breast Cancer

KANJINTI™ 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
  • As part of treatment 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 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

KANJINTI™ 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 trastuzumab product.

Metastatic Gastric Cancer

KANJINTI™ 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 trastuzumab product.

Please see full Prescribing Information, including Boxed WARNINGS.

Herceptin® (trastuzumab) is a registered trademark of Genentech USA, Inc.

References: 1. KANJINTI™ (trastuzumab-anns) Prescribing Information, Amgen. 2. Herceptin® (trastuzumab) Prescribing Information, Genentech, USA. 3. von Minckwitz G, Colleoni M, Kolberg HC, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018;19:987-998. 4. Hanes V, Chow V, Zhang N, Markus R. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects. Cancer Chemother Pharmacol. 2017;79:881-888. 5. Hanes V, Born T, Chow V, et al. Functional and human pharmacokinetic similarity of ABP 980 and trastuzumab. Poster presented at: European Breast Cancer Conference; March 9-11, 2016; Amsterdam, The Netherlands. 6. US Food and Drug Administration. FDA webinar - overview of the regulatory framework and FDA’s guidance for the development and approval of biosimilar and interchangeable products in the US. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm610901.htm. Accessed June 19, 2019. 7. Nixon N, Hannouf M, Verma S. The evolution of biosimilars in oncology, with a focus on trastuzumab. Curr Oncol. 2018;25:S171-S179. 8. Pegram MD, Bondarenko I, Zorzetto MMC, et al. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study. Br J Cancer. 2019;120:172-182. 9. Pivot X, Bondarenko I, Nowecki Z, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol. 2018;36:968-974. 10. Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18:917-928. 11. Chen X, Li C, Ewesudeo R, Yin D. Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer. Cancer Chemother Pharmacol. 2019; doi: 10.1007/s00280-019-03850-1 [Epub ahead of print]. 12. 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;317:37–47. 13. Cortés J, Curigliano G, Diéras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144:233-239. 14. Data on file, Amgen; [ABP 980 CSR 20120283; 2017]. 15. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed June 19, 2019.