Medicenna Gains FDA approval to Design a Hybrid Synthetic Control Arm | Medidata Case Study
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Medicenna gains precedent-setting FDA approval to design a hybrid Synthetic Control Arm® for a Phase 3 registrational trial
Medicenna, a mid-sized clinical-stage immunotherapy company, is on a mission to combat the world’s toughest diseases. One of Medicenna’s most promising molecules is MDNA55, a targeted therapy to treat recurrent Glioblastoma (rGBM). rGBM is one of the most aggressive forms of cancer with very limited treatment options.
Because of the unique challenges in studying, treating, and conducting rGBM trials, Medicenna faced difficulties interpreting the results of their single-arm Phase 2 study. The company needed to design a Phase 3 registrational trial that could successfully recruit and retain patients to demonstrate the effects of MDNA55 for registration.
Download this case study to see how a Synthetic Control Arm (SCA) helped Medicenna:
- Better understand the expected survival benefit for their treatment to bolster their Phase 2 findings
- Gain precedent-setting FDA approval to use a hybrid SCA in their Phase 3 registrational trial
- Reduce the number of prospective control patients needed in their Phase 3 study by approximately ⅔, or 100 patients