May 16, 2013
/PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today announced that the following presentations of data for L-BLP25 (formerly known as Stimuvax) and PX-866 will take place at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in
START - A Phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer.
Charles A. Butts
, MD, FRCPC Oral Abstract Session - Lung Cancer
Tuesday, June 4
9:45 AM - 10:00 AM
Phase II study of PX-866 in recurrent glioblastoma.
Marshall W. Pitz, MD, FRCPC
General Poster Session - CNS tumors
Saturday, June 1
8:00 AM - 11:45 AM
NCIC CTG, IND-205: A phase II study of PX-866 in patients with recurrent or metastatic castration resistant prostate cancer (CRPC).
Sebastien J. Hotte, MD, MSc
General Poster Session - Genitourinary Cancer
Monday June 3
8:00 AM - 11:45 AM
In connection with the upcoming presentation, Oncothyreon today announced detailed results from the randomized Phase III START trial of the investigational MUC1 antigen-specific cancer immunotherapy L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). The trial was conducted by Merck Serono, a division of Merck KGaA, Darmstadt,
, under a license agreement with Oncothyreon. The primary endpoint of improving overall survival (OS) was not met. In a predefined subgroup of patients receiving initial concurrent chemoradiotherapy (CRT), a combination of chemotherapy and radiotherapy given at the same time, a median overall survival of 30.8 months versus 20.6 months was observed based on a post hoc analysis in patients treated with L-BLP25 versus placebo respectively (HR 0.78, 95% CI 0.64-0.95, p=0.016, n=806).
The START trial is assessing the safety, efficacy and tolerability of L-BLP25 in patients with unresectable, locally advanced Stage III NSCLC who have not progressed after initial CRT, which is the current standard of care. Before receiving treatment with either L-BLP25 or placebo in the START trial, two-thirds of patients had received concurrent CRT and one-third had received sequential CRT (radiotherapy started after completion of chemotherapy). The trial did not meet its primary objective of demonstrating a significantly improved OS with L-BLP25 compared to placebo in the primary analysis study population (n=1,239). Median OS was 25.6 months for patients in the L-BLP25 group compared with 22.3 months for those in the placebo group (adjusted HR 0.88, 95% CI 0.75-1.03, p=0.123). In a post hoc analysis of the predefined subgroup of patients receiving initial concurrent CRT (n=806), patients receiving L-BLP25 had a median OS of 30.8 months compared to patients receiving placebo, who had a median OS of 20.6 months [HR 0.78; 95% CI 0.64-0.95; p=0.016]). In patients receiving sequential CRT followed by L-BLP25 or placebo a median OS of 19.4 months was observed for the L-BLP25 group compared with 24.6 months for the placebo group (n=433; HR 1.12; 95% CI 0.87-1.44; p=0.38). Predefined subgroup analyses included, among others, disease stage (IIIA or IIIB), response to initial CRT (stable disease versus objective response), type of initial CRT (concurrent versus sequential) and geographic region.