OncoGenex Says EMA Supports Phase 3 AFFINITY Trial Protocol Amendment

(RTTNews) - OncoGenex Pharmaceuticals, Inc. (OGXI) announced that the European Medicines Agency or EMA has completed its review of the proposed amendment to the company's Phase 3 AFFINITY protocol and statistical analysis plan.

The amendment, which was agreed to by the U.S. Food and Drug Administration or FDA earlier this year, includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer or mCRPC.

The company said the EMA supported plans for prospectively defining a poor prognostic subpopulation in the Phase 3 AFFINITY trial and suggested additional supportive analyses to show benefit for the poor prognostic subpopulation beyond the broader AFFINITY trial population. Following support from the FDA and EMA, the company is proceeding with its planned protocol amendment globally.

OncoGenex, in collaboration with study investigators, has defined a simple five-criteria characterization for poor prognostic patients with prostate cancer to be treated with custirsen based on the Phase 3 SYNERGY trial.

AFFINITY patients with poor prognosis will be identified as having two or more of these five well-recognized high-risk criteria. The proposed change for AFFINITY is also consistent with custirsen's mechanism of action, as custirsen was designed to address treatment resistance which may be more prevalent in this subpopulation.

AFFINITY is being conducted at 95 global clinical trial sites. Earlier this year, the IDMC recommended the trial continue following the completion of an interim futility analysis. The trial is fully accrued and the protocol amendment does not affect the conduct of the study. Custirsen has Fast Track designation by the FDA for the poor prognosis and overall AFFINITY trial populations, as well as non-small cell lung cancer or NSCLC.