OncoGenex Pharmaceuticals has reported results of a phase I/II study to determine the effectiveness of its investigational compound custirsen in conjunction with a gemcitabine/platinum-based regimen in patients with advanced non-small cell lung cancer (NSCLC).
Results published in the January 2012 issue of the Journal of Thoracic Oncology showed the additional treatment of custirsen, designed to block production of tumor cell survival protein clusterin, improved survival rates by three to seven months longer than patients who adhered to only a gemcitabine/platinum-based regimen. The combination treatment produced a median overall survival of 14.1 months, and progression-free survival of 4.3 months. Moreover, the patients who achieved a threshold minimum of serum clusterin (</= 45mcg/mL) had a median survival of 27.1 months.
Additionally, the study determined the toxicity of the combination treatment was not appreciably different from that reported for a gemcitabine/platinum-based regimen on its own.
"The identification and targeting of new therapeutic pathways, such as clusterin inhibition, are required in order to improve outcomes for cancer patients," said Dr. Janessa Laskin, principal investigator on the study and a medical oncologist at the British Columbia Cancer Agency.
The single-arm trial, conducted at 15 sites in North America, consisted of 81 patients with untreated, advanced NSCLC. OncoGenex has entered a collaboration and license agreement for custirsen with Teva Pharmaceutical Industries. The companies are planning a randomized, phase III study of custirsen as a first-line treatment of advanced, unresectable non-small cell lung cancer.