Final data from the failed, Phase III, AFFINITY trial of curstirsen + cabazitaxel + prednisone


In August we had reported on an announcement by OncoGenex Pharmaceuticals that, in the Phase III AFFINITY trial, the combination of custirsen + cabazitaxel (Jevtana) + prednisone had no significant impact on overall survival of men with metastatic, castration-resistant prostate cancer (mCRPC) who had already received first-line chemotherapy by comparison with cabazitaxel + prednisone alone.

Yesterday, a media release from the European Society for Medical Oncology (ESMO), at its annual meeting in Copenhagen, provided details of the actual results of the AFFINITY trial, as reported at the ESMO meeting by Fizazi et al.

Basically, the key data from this trial show that, among the 635 men randomized to either custirsen + cabazitaxel + prednisone or cabazitaxel + prednisone:

  • For all 635 men in the intent-to-treat population, average (median) overall survival was
    • 14.2 months for men given custirsen + cabazitaxel + prednisone
    • 13.4 months for men given cabazitaxel + prednisone
    • This difference was not statistically significant (hazard ratio [HR] = 0.946; two-sided p = 0.529).
  • For the 392 men whe met criteria for poor prognosis, average (median) overall survival was
    • 11.1 months for men given custirsen + cabazitaxel + prednisone
    • 10.9 months for men given cabazitaxel + prednisone
    • This difference was not statistically significant (HR = 0.918; p = 0.470)
  • More than a quarter of men in the trial discontinued therapy due to progressive disease:
    • 28.9 percent of men given custirsen + cabazitaxel + prednisone
    • 25.0 percent of men given cabazitaxel + prednisone
  • About another 20 percent of patients discontinued therapy as a consequence of adverse events:
    • 21.9 percent of men given custirsen + cabazitaxel + prednisone
    • 18.9 percent of men given cabazitaxel + prednisone
  • The most frequently reported adverse events of grade 3 or higher included neutropenia, anemia, fatigue, asthenia, bone pain, and febrile neutropenia.

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