Totality of Evidence | Kanjinti (trastuzumab) | Amgen

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BEHIND KANJINTI®
COMPREHENSIVE TOTALITY OF EVIDENCE

KANJINTI®’s DATA PACKAGE CONFIRMS ITS COMPARABILITY TO TRASTUZUMAB

It is important for biosimilars to demonstrate that switching with the reference product will not create safety issues or reduce effectiveness.1 KANJINTI® has undergone such rigorous studies, including a phase 3 trial with a single-switch arm, and this comprehensive totality of evidence effectively demonstrates its comparability to the trastuzumab reference product.

CLINICAL STUDY

LILAC study2-4
Randomised, double blind, phase 3 trial in HER2+ early breast cancer
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PHASE 1 STUDY

Clinical pharmacology5
PK/PD
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PRE-CLINICAL STUDIES

In vitro studies6-8
Analytical characterisation
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In vivo studies8
Nonclinical tumour models
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  1. Tabernero J, et al. ESMO Open 2016;1:e000142.
  2. von Minckwitz G, et al. Lancet Oncol. 2018; doi: 10.1016/S1470-2045(18)30241-9.
  3. Kolberg H-C, et al. SABCS 2017; Abstract PD3-10.
  4. von Minckwitz G, et al. SABCS 2017; Abstract P5-20-13 and poster.
  5. Hanes V, et al. Cancer Chemother Pharmacol. 2017;79:881–8.
  6. Hanes V, et al. SABCS 2015; Abstract P6-13-12 and poster.
  7. Hanes V, et al. EBCC 2016; Abstract 436 and poster.
  8. Hutterer K, et al. WCBP Symposium 2017; Abstract P-207-TH and poster.

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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.