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Phase III trial of OGX 011 (custirsen) in non-small cell lung cancer fails to meet primary endpoint- OncoGenex Pharmaceuticals

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Last updated:14th Oct 2016
Published:14th Oct 2016
Source: Pharmawand

OncoGenex Pharmaceuticals announced results from the final analysis of the Phase III ENSPIRIT trial of OGX 011 (custirsen) in patients whose non-small cell lung cancer (NSCLC) has progressed following initial treatments. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy.

The ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate custirsen for the treatment of advanced or metastatic NSCLC in patients who have progressed after initial chemotherapy treatment. The trial investigated 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. OncoGenex is continuing to work with MTS Health Partners who has been advising the company in the exploration of strategic alternatives since mid-August.

Comment: the company is expected to decide next steps once it receives the results of the apatorsen Phase II Borealis-2 bladder cancer trial which are expected by the end of October.

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