Investing.com — SELLAS Life Sciences stock fell 14% following the outcome of the interim analysis for its pivotal Phase 3 REGAL trial of GPS in Acute Myeloid Leukemia (AML). The Independent (LON:) Data Monitoring Committee (IDMC) recommended the trial to continue without modifications, despite the market’s negative response.
The interim analysis, conducted after 60 events (deaths) in the study population, was intended to assess the safety, potential efficacy, and continuation merit of the therapy. The IDMC found that the data supported the continuation of the study according to its original protocol. While the company’s CEO, Angelos Stergiou, expressed optimism about the IDMC’s recommendation and the potential of GPS to become a transformative treatment for AML, investors reacted negatively to the news.
SELLAS remains blinded to the trial outcomes to maintain study integrity, but select blinded data has shown a pooled median survival exceeding 12 months, which is favorable compared to the expected 6 months in a similar patient population. Additionally, an early immune response analysis in a sample of patients receiving GPS indicated an 80% GPS-specific immune response.
These outcomes align with previous GPS trials, where the median overall survival for GPS-treated patients was 21 months versus 5.4 months for patients on standard of care therapy. Despite these promising interim results and the company’s ongoing preparations for a Biologics License Application (BLA), the market’s reaction suggests concerns about the final trial outcomes and regulatory approval process.
Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical (TASE:) Center, conveyed hope for the therapy’s potential, based on previous trial outcomes, and indicated that GPS could become a new standard of care for AML patients in remission. He emphasized the therapy’s tolerability and minimal side effects, which are significant considering the severe side effects experienced by up to 60% of patients under standard therapies.
The REGAL trial is an open-label registrational clinical trial for GPS in AML patients in their second complete remission, with overall survival as the primary endpoint. The IDMC, consisting of independent medical, scientific, and biostatistics experts, is responsible for reviewing patient safety and efficacy data and ensuring the study’s validity and merits. The final analysis will be conducted after reaching 80 events, which is anticipated to occur this year.
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