Protocol Amended to Provide Faster Assessment of Survival Outcomes with Reduced Trial Size
The protocol amendment is designed to reduce the number of required patients enrolled in the trial and include an earlier, more rigorous second interim futility analysis. The protocol will now also include additional analyses, specifically an evaluation of overall survival (OS) by patient histology, as well as the effect of custirsen's efficacy among patients with poor prognostic risk factors. These changes do not affect the criteria for enrollment or conduct of the study, which continues to accrue patients. Enrollment is expected to be completed in the second half of 2016.
"The majority of people with NSCLC do not have specific genetic mutations that will respond to targeted therapy. New treatment options like custirsen, added to standard of care chemotherapy, are urgently needed for patients to control their cancer once it has progressed," said
Under the revised protocol, the following changes include:
"These protocol changes will provide us with a more expedient path to assess custirsen's potential survival benefit," said
Conference Call Details
OncoGenex will host a conference call at
About the Phase 3 ENSPIRIT Trial
The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in 700 patients who have progressed after initial chemotherapy treatment. 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. The trial is expected to enroll patients at approximately 50 sites globally. For more information on the ENSPIRIT trial, please visit http://clinicaltrials.gov/ct2/show/NCT01630733.
Custirsen is also being evaluated in the ongoing Phase 3 AFFINITY trial with second-line chemotherapy in men with metastatic castrate-resistant prostate cancer. After regaining development control of custirsen, and based on the improved survival benefit observed in poor prognostic patients treated with custirsen in the completed Phase 3 SYNERGY trial, OncoGenex plans to seek regulatory guidance regarding amendments to the AFFINITY protocol.
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
Custirsen has Fast Track designation by the
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. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company's Twitter account: https://twitter.com/OncoGenex_IR.
OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning the expected transfer from Teva to OncoGenex of clinical activities related to custirsen, statements regarding expected clinical trial accrual, completion and design and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that transfer of clinical trial responsibilities from Teva to OncoGenex is not completed as and when anticipated, the risk of delays in our expected clinical trials and the risk that changes in our clinical trial design are not acceptable to regulatory authorities or do not yield the expected benefits, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our product candidates do not demonstrate the hypothesized or expected benefits and the other factors described in our risk factors set forth in our filings with the
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