Sellas Life Sciences Announces Positive Outcome of Interim Analysis for Phase 3 REGAL Trial

Sellas Life Sciences Group, Inc. (NASDAQ: SLS) recently shared positive news regarding the interim analysis results from its Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the trial without modification following the interim analysis, which was triggered by reaching a milestone of 60 events (deaths) in the study population.

The assessment conducted by the IDMC, meant to evaluate the safety, potential efficacy, and need for continuation, supported the trial’s progression according to its original protocol. The interim data suggested promising signals of GPS efficacy, paving the way for the trial to move forward towards completion. A final analysis is set to take place once 80 events have occurred, further defining GPS’s potential in addressing the needs of AML patients. The company anticipates reaching this threshold sometime within the current year.

Angelos Stergiou, MD, ScD hc, President, and Chief Executive Officer of Sellas, expressed enthusiasm over the interim results, viewing them as a significant achievement for the GPS program. Stergiou highlighted the potential of GPS to become a transformative AML treatment, offering hope to patients with limited options, particularly those with relapsed or refractory disease. The resounding endorsement from the IDMC to continue the study as planned without adjustments has spurred Sellas to diligently prepare for the Biologics License Application (BLA) process.

Previously concealed data showed that fewer than half of the enrolled patients were confirmed deceased approximately 10 months post-enrollment completion, with a median follow-up of around 13.5 months. These figures suggested a median survival exceeding 12 months, a stark contrast to the expected survival rate of approximately 6 months in a comparable patient population. Additionally, an analysis of early immune response in a subset of patients revealed a GPS-specific immune response in 80% of those examined.

These favorable outcomes align with preceding GPS trials. Notably, in a Phase 2 study focused on AML patients in the second complete remission, GPS-treated patients exhibited a median overall survival of 21 months compared to 5.4 months for patients on standard care therapy, coupled with a GPS-specific immune response rate of 64%.

Reflecting on these encouraging developments, preparations are underway for the BLA regulatory submission, covering preclinical, clinical, manufacturing, and quality assurance aspects in anticipation of final clinical data. With the absence of an approved drug specifically designed for maintaining remission in AML patients, the significance of Sellas’ progress towards this objective is underscored.

The interim results have been heralded as a significant advancement in AML treatment, offering renewed hope for patients in remission. Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center, expressed optimism about the potential establishment of a new standard of care for AML patients given the positive outcomes observed in prior GPS trials. His sentiments were echoed during a recent webinar where he emphasized the high tolerability of GPS and its potential acceptance within the medical community and patient population alike.

The ongoing REGAL trial, a Phase 3 open-label registrational study targeting GPS in AML patients who have achieved complete remission post-second-line salvage therapy (CR2 patients), has the primary endpoint of overall survival. The IDMC, comprising independent medical, scientific, and biostatistics experts, is tasked with evaluating patient safety and efficacy data for REGAL, ensuring the study’s integrity and scientific rigor through regular reviews.

Sellas Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company, centers its focus on developing innovative cancer therapies. The company’s lead product candidate, GPS, licensed from Memorial Sloan Kettering Cancer Center, targets the WT1 protein found in various tumor types, while also exploring SLS009 as a differentiated small molecule CDK9 inhibitor with potential advantages in treating hematologic malignancies and solid tumors.

This press release contains forward-looking statements concerning the GPS clinical development program, including the REGAL study and its upcoming milestones. As with all such statements, there are inherent risks and uncertainties involved, as detailed in Sellas’ SEC filings, pertaining to oncology product development, regulatory approval uncertainties, and other factors. Sellas remains committed to providing updates and maintaining transparency throughout the development process.

Contact:
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
[email protected]

Media Contact:
Michael Fitzhugh
LifeSci Communications
[email protected]

Source: Sellas Life Sciences Group, Inc.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read SELLAS Life Sciences Group’s 8K filing here.

SELLAS Life Sciences Group Company Profile

SELLAS Life Sciences Group, Inc, a late-stage clinical biopharmaceutical company, focuses on the development of novel cancer immunotherapies for various cancer indications in the United States. The company’s lead product candidate is galinpepimut-S (GPS), a cancer immunotherapeutic agent that targets Wilms tumor 1, which is in Phase 3 clinical trials for the treatment of acute myeloid leukemia; and in Phase 1/2 clinical trials for the treatment for ovarian cancer.