OncoGenex Pharmaceuticals, Inc. (OGXI) announced that the Independent Data Monitoring Committee (:IDMC) has recommended the continuation of the randomized, open-label phase III ENSPIRIT study on custirsen for the treatment of advanced or metastatic non-small cell lung cancer (:NSCLC). The recommendation of the IDMC was based on the completion of the first interim futility analysis of the study.
In the phase III study, OncoGenex is evaluating custirsen in combination with Taxotere compared to Taxotere alone in advanced or metastatic NSCLC patients who have progressed after initial chemotherapy treatment. The IDMC will conduct a second futility analysis later in the course of this study.
We remind investors that OncoGenex has an agreement with Teva Pharmaceutical Industries Ltd. (TEVA) for the development and commercialization of custirsen. Custirsen is in two other phase III studies – AFFINITY (custirsen plus Jevtana as second-line chemotherapy in patients suffering from metastatic castrate resistant prostate cancer (:CRPC)) and SYNERGY (custirsen plus first-line treatment of Taxotere in metastatic CRPC patients). Final results from the AFFINITY study are expected in late 2015 or early 2016.
Custirsen has fast track designation in the U.S. for the treatment of advanced or metastatic NSCLC.
We expect investor focus to remain on further updates from the company on custirsen. Meanwhile, OncoGenex is evaluating apatorsen in seven phase II studies for four types of cancer − bladder, lung, pancreatic and prostate cancer. Results from the Borealis-1 study (metastatic bladder cancer) should be out in the first quarter of 2015.
OncoGenex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Endo International plc (ENDP) and United Therapeutics Corp. (UTHR). Both carry a Zacks Rank #1 (Strong Buy).