Oncothyreon's PX-866 misses PFS endpoint in NSCLC

Oncothyreon Inc. (NASDAQ:ONTY) disclosed in its 1Q13 earnings late Thursday that once-daily oral PX-866 plus docetaxel missed the primary endpoint of improving progression-free survival (PFS) vs. docetaxel alone in a cohort of patients with non-small cell lung cancer (NSCLC) in the open-label Phase II portion of a Phase I/II trial to treat advanced metastatic solid tumors. Patients were on as second- or third-line chemotherapy. Oncothyreon expects data later this year from a separate cohort of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure of prior therapy. PX-866, an oral phosphoinositide 3-kinase (PI3K) inhibitor, is also in Phase II testing to treat glioblastoma multiforme (GBM) and recurrent or metastatic castration-resistant prostate cancer (CRPC) and in Phase I/II testing to treat melanoma and colorectal cancer. ...