Apricoxib Prolongs Time-to-Progression and Overall Survival in Biomarker-Selected NSCLC Patients

CHICAGO and SAN DIEGO, June 6, 2011 /PRNewswire/ -- Tragara Pharmaceuticals, Inc. announced today that apricoxib (Capoxigem®, TG01) in combination with erlotinib demonstrated significant and consistent clinical benefit over erlotinib alone in a clinically relevant subset of biomarker-selected patients with non-small cell lung cancer (NSCLC) who had previously failed a platinum-containing regimen for advanced disease. Complete data from the study, APRiCOT-L, were presented during the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago. Apricoxib is Tragara's novel, oral, once-daily COX-2 inhibitor in development for the treatment of a variety of cancers.

In the trial "APRiCOT-L: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination with Erlotinib in Non-Small Cell Lung Cancer Patients" (Abstract #7528, Poster #17), combination therapy with apricoxib and erlotinib demonstrated significant benefits over erlotinib and placebo in the subset of patients < 65 years-of-age including:

• 71% improvement in disease control rate;
• 93% improvement in median progression-free survival; and
• 205% improvement in median overall survival.

"APRiCOT-L results demonstrating clinical benefit are the first reported for a study that employed modulation of a functional biomarker to prospectively select patients for treatment with a COX-2 inhibitor," stated Barbara Gitlitz, MD, Associate Professor of Clinical Medicine, USC/Norris Comprehensive Cancer Center Keck School of Medicine. "The benefits seen in TTP and OS are impressive and apricoxib is a promising new agent advancing into Phase III development."

The study, a Phase II randomized, double-blind, multi-center, placebo-controlled trial, evaluated time-to-progression as the primary endpoint in 120 patients at oncology centers in th

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