The trial combines nimotuzumab with radiation for the treatment of diffuse intrinsic pontine glioma (DIPG), an inoperable form of brain cancer. The trial is being conducted by an international group of paediatric oncologists under the lead of principal investigator Professor Udo Bode at the University of Bonn, Germany. The primary end-point is progression-free survival with overall survival as a secondary endpoint. Nimotuzumab has been designated an orphan drug by the EMEA.
YM has cited positive European data from a completed second line 47-patient Phase II nimotuzumab monotherapy trial in recurrent pediatric glioma, with a clinical benefit rate of 38% after 8 weeks, including partial responses and stable disease.
Additionally, YM claims, more than half of the high-grade brain cancers or gliomas over-express epidermal growth factor receptor (EGFR) and for the most advanced brain cancers, glioblastoma multiforme (GBM), the level of expression is even higher. A study involving 29 adults with newly diagnosed high-grade gliomas, including both anaplastic astrocytomas (AA) and GBM, who were treated with surgery, external beam radiotherapy and nimotuzumab showed that the treatment was well tolerated, the median survival time was 17.5 months for the GBM patients, and has not yet been reached for the AA patients.