Results of Phase III trial of custirsen (OGX-011) in mCRPC coming soon


According to a media release issued early this morning by OncoGenex Pharmaceuticals, the Phase III SYNERGY trial of custirsen (originally known as OGX-011) has reached its pre-specified endpoint in terms of the number of events required for final analysis of the trial data.

Based on this media release and the information about the SYNERGY trial available on the ClinicalTrials.gov web site, the implication is that a sufficient number of patients with metastatic, castration-resistant prostate cancer (mCRPC) have died in either one or both arms of the trial to be able to tell whether the men randomized to treatment with docetaxel + prednisone + custirsen had significantly better survival (or not) than the men randomized to treatment with docetaxel + prednisone + a placebo.

The SYNERGY trial enrolled a total of 1,022 patients at nearly 150 centers in North America, Europe, Israel and South Korea. Patients randomized to treatment with custirsen received three “loading doses” of the drug followed by weekly infusions of 640 mg for up to 10 cycles of treatment.

According to the company’s media release,

Our teams are working diligently in order to announce survival results as soon as they are available, and we sincerely appreciate the support of the investigators, and most importantly, the men and their families who participated in this important trial.

It is possible that these data may be available in time them to be given as a “late-breaking” presentation at the annual meeting of the American Society of Clinical Oncology in late May/early June this year.

One Response

  1. I hope we get some positive news on custirsen. I believe in the past that no combination with docetaxel has been shown to be better than just docetaxel by itself.

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