IDMC recommends continuation of Ph 3 REGAL Trial of GPS in AML
“I am thrilled by the positive outcome of the interim analysis of our Phase 3 REGAL trial, marking the successful achievement of the most significant milestone for our GPS program to date. The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval for the treatment of AML,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease. We are optimistic about the IDMC’s recommendation to continue the study without modifications, and diligently preparing for the Biologics License Application (BLA). Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission. We look forward to completing the trial with the final analysis to be conducted once 80 events are reached.”
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