OncoGenex commences custirsen Phase 3 trial in non-small cell lung cancer

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed. The trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients.  Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.

"Despite breakthroughs in molecular targeting for advanced NSCLC, most patients require chemotherapy and unfortunately, often progress to require second-line treatment," said Cindy Jacobs, Ph.D, MD, Chief Medical Officer and Executive Vice President of OncoGenex Pharmaceuticals. "Given custirsen's enhancement of taxanes pre-clinically as well as with a wide range of anti-cancer agents, even in chemo-resistant models, we are eager to learn if custirsen can improve docetaxel outcomes in patients with progressive NSCLC."

Custirsen is unique in that it augments anti-cancer treatments by blocking the production of clusterin, a protein linked to faster rates of cancer progression and shorter survival duration.  A single-arm trial in first-line NSCLC evaluating custirsen in combination with a gemcitabine/platinum-based chemotherapy regimen demonstrated a median overall survival of 14.1 months, decreased serum clusterin levels in 95% of patients evaluated, and an acceptable safety profile. In this trial, lower serum clusterin levels correlated to longer survival outcomes.

"The custirsen development program now has three Phase 3 studies enrolling patients to evaluate the potential benefit of combining custirsen with chemotherapy regimens," said Scott Cormack, CEO and President of OncoGenex Pharmaceuticals. "We are pleased that Teva has initiated this Phase 3 study of custirsen in advanced NSCLC, a difficult disease to treat and where effective and tolerable treatment options are desperately needed."

Custirsen received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with castrate-resistant prostate cancer (CRPC) receiving first-line docetaxel chemotherapy. The Phase 3 SYNERGY study, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year. Additionally, OncoGenex recently announced initiation of patient enrollment in AFFINITY, a second Phase 3 study in patients with CRPC, evaluating a survival benefit in combination with second-line chemotherapy, Jevtana® (cabazitaxel).