YM BioSciences announces results of nimotuzumab Phase II study on DIPG

October 14, 2017

Of 46 patients enrolled, 44 received at least one dose of nimotuzumab. Nineteen patients (43.2%) completed the induction phase, five patients (11.4%) completed the consolidation phase, and three patients (6.8%) continued to receive nimotuzumab after completing the consolidation phase. Seven patients (15.9%) died due to disease progression. Treatment with nimotuzumab was well tolerated with most adverse events reported as mild or moderate in severity. The majority of Adverse Events (AEs) were associated with CNS disorders and not related to study drug. The most commonly reported events related to study drug were rash and lymphopenia occurring in 9.1% and 6.8% of patients respectively. Study drug discontinuation was reported in four patients overall due to AEs. Only one patient experienced serious Adverse Events (Grade 5 intracranial tumor hemorrhage and tumor necrosis), assessed as possibly related to nimotuzumab.

No Complete Responses (CR) were observed. At week 8, a PR was reported in two patients, SD in six patients and Progressive Disease (PD) in 11 patients who were evaluable for response, resulting in a Clinical Benefit Rate (CR+PR+SD) of 18.2%.  At week 18, one patient continued to have a PR and three patients continued with SD, giving an Overall Response Rate of 2.3%. The Median Duration of Response, Time to Progression, and Overall Survival were 2.1 months, 1.7 months and 3.2 months respectively.

Nimotuzumab is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.

SOURCE YM BioSciences Inc.