Sipuleucel-T can be successfully manufactured during concurrent administration of abiraterone acetate plus prednisone without impacting immunologic effect or changing immune parameters that are associated with the immunotherapy’s clinical benefit, a phase II trial published in the journal Clinical Cancer Research has shown.
For the study, researchers sought to determine whether concurrent or sequential administration of abiraterone acetate plus prednisone has an effect on sipuleucel-T manufacture and immune responses in patients with metastatic castration-resistant prostate cancer.
Researchers enrolled 69 patients and randomly assigned them to receive the drug combination concurrently or sequentially. All patients continued abiraterone and prednisone for 26 weeks.
Results showed that cumulative antigen presenting cell activation was significantly higher at the second and third infusions of sipuleucel-T compared with baseline. This effect was similar in both arms (P<0.05).
Moreover, researchers found that sipuleucel-T product parameter profiles and peripheral immune responses were consistent with previous phase 3 trials.
In regard to safety, the combination of all three agents was well tolerated and no new safety signals were identified.