Oncoscience AG announces final results of a phase-II study in pediatric patients with recurrent high-grade malignant glioma treated with the monoclonal antibody NIMOTUZUMAB directed against EGF-R, as monotherapy
Oncoscience | June 8th, 2007
Final results of the Phase II trial were described in an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on Sunday, June 3rd 2007, in Chicago, by Professor Dr. Udo Bode, University of Bonn, Germany, the Principal Investigator of the study (Abstract #2006).
The trial included 47 heavily pre-treated patients with a median age of 11 years of which 45 were evaluable for response (11 patients with anaplastic astrocytoma (AA) grade III, 13 with glioblastoma multiforme (GBM) grade IV and 21 with diffuse intrinsic pontine glioma (DIPG)). All the AA and GBM patients had undergone surgery and were treated with radiation and multiple courses of different chemotherapy. The DIPG patients were treated with radiation and multiple courses of different chemotherapy.
The most important inclusion criteria were: documented progressive disease by MRI (independently assessed by a reference radiologist) at the time of entry into the study and expected survival time of not less than four weeks.
Nimotuzumab monotherapy was administered at a dose of 150 mg/m² weekly for six weeks (an induction period) and, for patients who had not progressed following induction period, treatment continued once every three weeks until week 21 or disease progression (consolidation period). First MRI assessment at week 8 shows 2 PR and 14 SD which results in a 35.6% response rate. Twelve out of 45 patients entered for consolidation therapy; four partial responses (PR), two stable disease (SD) and six disease progressions (PD) were reported. In the 21 patients with DIPG an overall clinical benefit rate of 38.1% was observed (1 PR, 7 SD) in the induction phase. In the consolidation phase, four of the eight patients with DIPG received additional clinical benefit (3 PR, 1 SD). The median survival in patients with clinical benefit was three times longer (8.9 months compared to 3.3 month) as in patients who did not respond to treatment. This length of survival in patients with recurrent disease approaches the historical median survival for newly diagnosed paediatric patients with high malignant glioma. Even more important was the observation that in these end stage patients the unexpectedly long median survival was accompanied by an excellent quality of life. No drug related rash, diarrhoea, conjunctivitis etc. (which normally is reported with use of EGFR antibodies) has been seen. Some patients were no longer wheel chair bound, and were able to feed themselves, attend kindergarten or school and have long home rather than institutional care.”
Based on these results, a first line Phase-III study in 40 paediatric patients newly diagnosed with DIPG was initiated in March 2006 and recruitment is expected to be completed in Q3/2007.
Oncoscience AG is a private company in Germany focused principally in oncology. Oncoscience AG licensed the monoclonal antibody, nimotuzumab, from CIMAB and CIMYM Inc. a majority-owned subsidiary of YM BioSciences Inc., in Canada.