Case Study: Medicenna achieves precedent-setting FDA approval with Medidata Solutions

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, needed a way to interpret results from its single-arm Phase 2 study of MDNA55 for recurrent glioblastoma and design a Phase 3 registrational trial that could better recruit and retain patients. Because the disease is so aggressive and hard to study, Medicenna turned to Medidata Solutions and its Medidata AI service to help create a more rigorous control strategy.

Medidata Solutions used a Synthetic Control Arm to re-analyze Phase 2 data and support a hybrid SCA design and statistical analysis plan for Phase 3. The FDA agreed to consider this precedent-setting approach, and the hybrid design is expected to reduce the number of prospective control patients by about 100, or roughly two-thirds, while improving enrollment, reducing drop-out, and accelerating timelines without sacrificing scientific interpretability.

Medicenna

Fahar Merchant

President and CEO