"Despite breakthroughs in molecular targeting for advanced NSCLC, most patients require chemotherapy and unfortunately, often progress to require second-line treatment," said
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
Custirsen received Fast Track designation from the
For more information on the ENSPIRIT trial, please visit http://clinicaltrials.gov/ct2/show/NCT01630733.
ENSPIRIT is an international, randomized, open-label study that will enroll approximately 1,100 patients with advanced or metastatic NSCLC who have been previously treated with a first-line platinum-based chemotherapy and have documented disease progression. Patients will be randomized to receive custirsen plus docetaxel or docetaxel alone. The primary objective of the study will be overall survival with additional secondary and exploratory analyses of other efficacy outcomes and biomarker relationships. 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.
Custirsen is the only compound currently in development designed to inhibit the production of clusterin, a protein commonly over-produced in cancer cells, and one cause of treatment resistance. As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. Some of the patients experienced a variety of adverse events, the majority of which were associated with other treatments in the protocol and the disease. The majority of adverse events were mild and the most common adverse events associated with custirsen consisted of flu-like symptoms. The most common serious adverse events (SAE) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea. Each SAE event was observed in approximately 2%-4% of patients.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and
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