Positive Results from SELLAS' Pivotal Phase 3 REGAL Trial in AML

Positive Interim Analysis of REGAL Trial Announced

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently revealed a successful outcome from the interim analysis of its Phase 3 REGAL trial, which focuses on the efficacy of galinpepimut-S (GPS) in treating acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) analyzed the data following a predefined threshold of 60 patient deaths and has recommended the trial to progress without modifications.

Significant Survival Data from REGAL Trial

The purpose of this interim analysis was to evaluate the safety, potential efficacy, and overall viability of the therapy. Findings indicate that GPS surpassed the anticipated futility limits, displaying no safety concerns, and delivering praise to SELLAS for the integrity of study and operational execution. In a notable development, fewer than 50% of patients enrolled in the trial were confirmed deceased after a median follow-up of 13.5 months, indicating improved survival rates compared to traditional therapies.

Encouraging Survival Statistics

Patients in the REGAL trial exhibited a median survival time exceeding 13.5 months, in stark contrast to the historical average of 6 months associated with standard AML treatments. Additionally, 80% of the trial participants showed a robust T-cell immune response, demonstrating a significant increase over previous Phase 2 trial findings.

Future Steps and Final Analysis Anticipated

SALAS anticipates that the final analysis of the REGAL trial will take place once another 80 events occur. This next step is critical, as it will provide further clarity around the effectiveness of GPS as a treatment option. Angelos Stergiou, MD, ScD hc, President and CEO of SELLAS, expressed excitement regarding the IDMC's recommendation, acknowledging it as a pivotal milestone and affirming the company’s commitment to preparing for the Biologics License Application (BLA).

Impact of GPS on the AML Landscape

The overall thrust of the REGAL trial is to solidify GPS's position as a potential game-changer in AML treatment, particularly for patients with limited options, such as those with relapsed or refractory disease. The opportunity for patients to access a transformative therapy such as GPS is a significant step toward enhancing the quality of life for those battling this aggressive form of cancer.

Collaboration and Continued Research

Despite being blinded to trial outcomes for integrity purposes, data presented from a randomly selected patient group has revealed a promising immune response that aligns with past GPS research findings. In earlier studies, patients receiving GPS treatment displayed markedly higher median overall survival rates compared to those undergoing standard treatments, reinforcing the potential for advancement in treatment options.

Insights from Clinical Experts

Experts in the hematologic field have echoed the sentiments regarding the importance of these trial results. Dr. Yair Levy, from Texas Oncology Baylor University Medical Center, noted the interim results provide hope for establishing a new standard of care in AML treatment. The positive evaluations from the previous GPS studies suggest that this innovative therapy could be well-received by both the medical community and patients alike.

About SELLAS Life Sciences Group, Inc.

SELLAS is committed to developing groundbreaking therapeutics designed to address a variety of cancer types. With GPS as their leading candidate, licensed from Memorial Sloan Kettering Cancer Center, the company is at the forefront of innovation in cancer treatment. Additionally, SELLAS is advancing SLS009, a promising CDK9 inhibitor aimed at improving outcomes for patients with challenging prognostic factors.

Frequently Asked Questions

What is the REGAL trial?

The REGAL trial is a Phase 3 open-label clinical trial evaluating the effectiveness of galinpepimut-S (GPS) for patients with acute myeloid leukemia who have achieved second complete remission.

What were the key findings from the interim analysis of the REGAL trial?

The interim analysis indicated that GPS surpassed expected futility limits, showed promising survival outcomes, and received support for continued trial advancement.

What does the IDMC recommendation mean for the trial?

The IDMC's recommendation to continue without modifications is a positive affirmation of the trial's design and the potential efficacy of GPS in treating AML.

What is the next step in the REGAL trial?

The next step entails completing the trial upon reaching 80 events, which will enable further assessment of GPS's effectiveness as a treatment option for AML.

How does GPS compare to traditional AML therapies?

GPS has demonstrated significant improvement in terms of median survival rates and immune response when compared to conventional treatments, making it a potentially transformative option for AML patients.

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