Nimotuzumab is a humanized MAb that binds to the extracellular domain of the EGFR, a signaling
protein involved in the regulation of cell growth and differentiation (Hynes and Lane, 2005; Alvarez et
al., 2007). Studies have shown that EGFR-targeting with nimotuzumab mediates anti-tumor effects by
inhibiting proliferation, survival, and angiogenesis (Ramakrishnan et al., 2009). In addition,
nimotuzumab may also be cytolytic on target tumors due to its ability to cause antibody-dependent
cellular cytotoxicity and complement-dependent cytotoxicity (Diaz Migueli et al., 2007).
Nimotuzumab’s bivalent binding mechanism also allows for selective binding on cells that express
moderate to high levels of EGFR expression, which may reduce the incidence of off-target toxicities
(Tikhomirov et al., 2008; Garrido et al., 2011).
Nimotuzumab (Oncoscience AG/Daiichi Sankyo) is an epidermal growth factor receptor (EGFR)-
targeted monoclonal antibody (MAb) currently under Phase III development for the second-line
treatment of advanced gastric cancer. Phase II clinical trials showed nimotuzumab plus irinotecan did
not demonstrate statistically significant improvements in patient outcomes and response rates
compared with irinotecan monotherapy. Subgroup analysis later revealed that nimotuzumab may be
effective in moderate to high EGFR-expression tumors. The ongoing Phase III ENRICH trial targets
patients with confirmed EGFR overexpression. The EGFR-overexpressing patient group now represents
nimotuzumab’s best chance of gaining regulatory approval.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 nimotuzumab : Gastric cancer
LIST OF FIGURES
10 Figure 1: Nimotuzumab for gastric cancer – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary for nimotuzumab in gastric
11 Figure 3: Datamonitor Healthcare’s drug assessment summary for nimotuzumab in gastric
LIST OF TABLES
4 Table 1: Nimotuzumab drug profile
6 Table 2: Nimotuzumab late-phase trial in gastric cancer
7 Table 3: Nimotuzumab early-phase data in gastric cancer
Datamonitor Healthcare is part of Pharma intelligence
Datamonitor Healthcare is a trading division of Datamonitor Limited, a company registered in England and Wales with company number 2306113 whose registered office is 5 Howick Place, London, SW1P 1WG. VAT GB365462636. Datamonitor Limited is part of Informa PLC.
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726