PX-866: Development discontinued

Oncothyreon said it does not plan to move forward with development of PX-866 for GBM after data from 33 evaluable patients with GBM at first recurrence after chemoradiation and adjuvant temozolomide in a 2-stage, single-arm, open-label, Canadian Phase II trial showed that once-daily 8 mg oral PX-866 missed the primary endpoint of ORR. Specifically, the ORR was 3% with 1 partial response. There were 7 cases of stable disease and 25 cases of disease progression. Oncothyreon said the endpoint would be considered met if there were >=4 responses or <=13 early progressions. The 6-month progression-free survival (PFS) rate was 17%. PX-866 was well tolerated with liver function test abnormalities, fatigue, diarrhea, nausea, vomiting and lymphopenia reported as adverse events. Data will be presented at the American Society of Clinical Oncology meeting in Chicago on June 1. The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) sponsored the trial. ...