SELLAS Life Sciences Group's galinpepimut-S (GPS) has shown promising results in the interim analysis of its Phase 3 REGAL trial for acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) has recommended that the trial continue without modifications, signaling potential efficacy and safety of GPS in AML patients who have achieved complete remission following second-line salvage therapy.
The REGAL trial, an open-label registrational study, aims to evaluate the efficacy of GPS in prolonging overall survival in AML patients. The IDMC's recommendation follows a review of unblinded data, which confirmed that GPS exceeded predetermined futility criteria and raised no safety concerns. This positive evaluation suggests that GPS could offer a new treatment option for AML patients with limited choices, especially those with relapsed or refractory disease.
Interim Analysis Details
The interim analysis was triggered after 60 events (deaths) were recorded in the study population. Key findings from the analysis include:
- Fewer than 50% of enrolled patients confirmed deceased after a median follow-up of 13.5 months, indicating a median survival exceeding 13.5 months.
- This compares favorably to the historical median survival of 6 months for conventional therapy, as reported in a similar Phase 2 study.
- 80% of randomly selected GPS patients showed a specific T-cell immune response, surpassing results from the previous Phase 2 study.
These data are consistent with previous GPS trials. In a Phase 2 study in AML patients in second complete remission, the median overall survival of GPS-treated patients was 21 months versus 5.4 months for patients on standard of care therapy, with a GPS-specific immune response of 64%.
Expert Commentary
"The interim results represent a major step forward in the treatment of AML, offering hope for patients in remission," said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center. "I am very hopeful that we will see a new standard of care in treating AML patients based on the outcomes we have observed in previous GPS trials."
Dr. Levy also noted that GPS is a well-tolerated therapy with minimal side effects, which is particularly important given that up to 60% of patients receiving standard therapies experience severe side effects like decreased blood cell counts, often necessitating hospitalizations.
Next Steps
The next and final analysis of the REGAL trial is planned upon reaching 80 events (deaths). SELLAS anticipates this will occur this year and is diligently preparing for the Biologics License Application (BLA). If approved, GPS would be the first drug specifically for maintenance of remission in AML patients in second complete remission.
About the REGAL Study
The REGAL study is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts responsible for reviewing patient safety and efficacy data and monitoring the study's conduct to ensure its validity.
