Adjuvant recMAGE-A3 Immunotherapy After Cystectomy for Muscle-invasive Bladder Cancer: Lessons Learned from the Phase 2 MAGNOLIA Clinical Trial
Abstrakt
The MAGNOLIA study represented a unique opportunity to investigate the concept of immunotherapy in BC. After premature termination, no clinically significant signal of efficacy could be shown.
Any interpretation of the survival data should take into account that the number of participating patients was limited and that only patients receiving recMAGE-A3 + AS15 (n = 9) continued treatment following the decision to stop the trial. This resulted in a longer ("survival") time in the study in the recMAGE-A3 + AS15 arm compared to the placebo arm.
Lessons learned include the identification of multiple barriers to patient accrual, including study complexity, the involvement of multiple international departments, specific referral issues, the timing of two-step informed consent, slow patient recovery after cystectomy, eligibility criteria, and country-specific competing (neo)adjuvant therapy. These issues should be recognized in order to plan and conduct successful future clinical trials on perioperative therapy in BC in Europe.
The biological samples collected will be used for further translational research in the targeted therapy perioperative setting.