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OncoGenex (OGXI) Releases Phase 3 ENSPIRIT data of Custirsen for Advanced Non-Small Cell Lung Cancer (NSCLC)

Source Link:: http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=946232

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Additional Information

Additional Relevant Details The company's other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.

http://ir.oncogenex....

Additional Relevant Details As a result of these data and previous custirsen findings, OncoGenex plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to evaluate options related to an early analysis of the Phase 3 ENSPIRIT trial investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC)."Given that the ENSPIRIT trial has nearly completed enrollment and we believe there are likely a sufficient number of events to determine the effect of custirsen in NSCLC, we are eager to expedite the final data analysis, which would allow us to conserve resources and fully understand the value of the asset as we evaluate our alternatives to maximize shareholder value," said Cormack.

http://ir.oncogenex....

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Catalyst Date

Occurred on:

Oct 13, 2016

Occurred Source:

http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=993375

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Related Keywords Phase 3 Data, Custirsen, Enspirit Trial, Nsclc, 2h 2016, Docetaxel, Chemotherapy, Enspirit, Advanced Non-small Cell Lung Cancer