OncoGeneX/Teva halt SATURN trial, start new Phase III study with OGX-011

According to a media release from the companies issued yesterday, OncoGeneX and Teva have stopped enrolling patients into the SATURN trial, which was designed to see if OGX-011 (custirsen) could ameliorate bone pain in men who had already been treated with (and were non-responsive to) docetaxel-based chemotherapy.

As a replacement for the SATURN trial, OncoGeneX and Teva are planning to initiate a new Phase III trial that is designed to assess the efficacy and safety of  custirsen in combination with cabazitaxel as a second-line, combination chemotherapeutic treatment for men who have already received at least one cycle of docetaxel-based chemotherapy. The endpoint for this trial will be survival, although it is not yet clear whether that implies progression-free survival, overall survival or both. The trial will enroll 630 patients, who will presumably be randomized to a regimen of either cabazitaxel + prednisone + custirsen or to cabazitaxel + prednisone + a placebo. We also assume that patients will be given other forms of supportive care, as necessary. As yet there are no details of this trial available on ClinicalTrials.gov, but the companies have stated that the trial will start “later this year.”

According to the companies’ joint media release, “The shift in focus to evaluate overall survival in second-line prostate cancer is a result of numerous, recently-approved agents that are redefining the standard of care in this patient setting.” However, one cannot help wondering whether, with the approval of cabazitaxel and abiraterone, and the potential approval of other drugs in the near future, they had been having problems accruing patients to the SATURN trial.

The companies are careful to point out that the Phase III SYNERGY trial, designed to evaluate the combination of docetaxel + prednisone + custirsen against docetaxel + prednisone alone, is ongoing. Apparently this trial is still recruiting patients.

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