SELLAS Life Sciences Provides Update on Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)
MWN-AI** Summary
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has provided a significant update on its pivotal Phase 3 REGAL trial, which investigates the efficacy of Galinpepimut-S (GPS) as a maintenance therapy for Acute Myeloid Leukemia (AML) patients who have reached second complete remission (CR2). As of December 26, 2025, the trial has recorded 72 events, defined as patient deaths, essential for the overall survival analysis that will trigger the final results. The anticipated 80th event, necessary for the final analysis, is yet to occur.
The Independent Data Monitoring Committee (IDMC) previously advised that the trial should continue as planned, which had led to expectations for the 80th event to take place by the end of the year. SELLAS remains blinded to the trial outcomes, affirming that no interim efficacy analysis has influenced future data evaluations. The IDMC continuously monitors safety and efficacy to ensure the trial's integrity.
CEO Angelos Stergiou emphasized the commitment to advancing innovative therapies, expressing appreciation for the contributions of patients and investigative teams. Dr. Yair Levy from Texas Oncology highlighted the trial's significance, noting that patients who cannot undergo transplants typically face a median overall survival of around eight months with current treatments, underscoring the unmet need for novel therapies like GPS.
Additionally, SELLAS is advancing its SLS009 program, a promising CDK9 inhibitor aimed at treating AML patients with adverse prognostic markers. The progress of the REGAL trial and potential outcomes could have substantial implications for treatment paradigms in AML, representing a critical advancement in cancer therapy. Further updates will follow upon the occurrence of the 80th event.
MWN-AI** Analysis
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently provided a pivotal update regarding its Phase 3 REGAL trial for Galinpepimut-S (GPS), a promising candidate in the treatment of Acute Myeloid Leukemia (AML). As of December 26, 2025, a total of 72 events have been reported, bringing the trial closer to the necessary 80 events required for final analysis. While the completion of this analysis remains a key focus, SELLAS is currently “blinded” to the outcomes, which complicates immediate investment insights.
The REGAL trial aims to assess GPS as a potential maintenance therapy in patients achieving a second complete remission. The enduring uncertainty surrounding trial results highlights the need for investors to exercise caution. With the anticipated final analysis dependent on the occurrence of the 80th event, fluctuations in event reporting could significantly impact stock performance.
Institutional interest in SELLAS could remain strong if the eventual results showcase improved survival rates, especially when compared to the expected median overall survival of approximately eight months for conventional treatments. Notably, the Independent Data Monitoring Committee’s (IDMC) decision in August 2025 to continue the trial without modifications is a positive indicator, suggesting that interim data may have been reassuring.
However, potential investors should weigh the associated risks given the historical volatility around biotech companies based on clinical outcomes. SELLAS is also investing in SLS009, a differentiated CDK9 inhibitor showing high response rates in challenging AML patient cohorts, which could diversify investment value and reduce risk exposure.
In conclusion, while the momentum around the REGAL trial is worthy of consideration, market participants should remain vigilant about the risks inherent in clinical outcomes. Awaiting the 80th event will provide crucial insights into the viability of GPS, and may ultimately guide investment strategies for stakeholders in SELLAS Life Sciences.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Contract Research Organization for the REGAL trial has informed the Company that 72 events have occurred in the trial as of December 26, 2025; SELLAS remains blinded to trial outcomes
- Timing of the final analysis is event-driven, and SELLAS will announce the occurrence of the 80th event
NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided an update on the ongoing Phase 3 REGAL trial evaluating GPS as a potential maintenance therapy in patients with AML after second complete remission (CR2).
Following the Independent Data Monitoring Committee (IDMC) recommendation in August 2025 that the Phase 3 REGAL trial continue without modification, it was expected that the 80th event (death) required to trigger the final analysis would occur before year-end. The REGAL trial is an overall survival study, and per the statistical analysis plan, the final analysis will be triggered once 80 events (deaths) have occurred.
SELLAS was informed by its contract research organization managing the REGAL trial that the pooled number of events was 72 as of December 26, 2025. SELLAS remains blinded to all efficacy and survival data outcomes and, as no outcomes analyses were performed and no statistical penalty has been incurred, this one-time update on the aggregate number of events does not impact future statistical analyses. Because the final analysis is event-driven, and the timing of studies with overall survival as an endpoint can vary, SELLAS will announce the 80th event when it occurs.
“We appreciate the continued dedication of the patients, families, and investigators participating in the pivotal Phase 3 REGAL trial where survival times, fortunately for patients and caregivers, appear longer than expected,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “While the 80th event has not yet occurred, and we remain fully blinded, every passing month may increase the probability of a successful study as highlighted by key opinion leaders in our recent R&D event. Conclusive data will follow the unblinding and analyses of the study results. We remain steadfast in our commitment to advancing breakthrough therapies, such as GPS, that possess the potential to significantly improve the lives of patients with AML.”
“The REGAL study represents a meaningful effort to evaluate GPS as a novel therapeutic approach in an AML population with significant unmet need,” said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center, and a member of the REGAL Steering Committee. “For patients who are unable to undergo transplant, as in the REGAL study, their treatment usually consists of a combination of hypomethylating agents and/or a BCL-2 inhibitor, with an expected median overall survival of around eight months. We hope to see an extended survival benefit, with a tolerable safety profile, as observed in previous GPS studies.”
SELLAS Life Sciences Virtual R&D Day – October 29, 2025: Advancing Novel Therapies in Acute Myeloid Leukemia (AML): An Overview of the Ongoing Phase 3 REGAL Trial of Galinpepimut-S (GPS) and SLS009 Program Update. To access a replay of the R&D Day, please click here.
About Phase 3 REGAL Trial
REGAL (NCT04229979) is a Phase 3 randomized 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 who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
John Fraunces
Managing Director
LifeSci Advisors, LLC
FAQ**
What measures is SELLAS Life Sciences Group Inc. SLS taking to ensure patient safety and data integrity during the ongoing Phase 3 REGAL trial, given that it remains blinded to trial outcomes?
How does SELLAS Life Sciences Group Inc. SLS plan to communicate the significance of the 80th event occurrence to investors and stakeholders once the final analysis is triggered in the REGAL trial?
Can SELLAS Life Sciences Group Inc. SLS provide insights into the potential impact of the 72 recorded events on the project timeline and future clinical strategies for the GPS therapy within the REGAL trial framework?
Given that SELLAS Life Sciences Group Inc. SLS is focused on AML patients, how does the company plan to address the uncertainties associated with overall survival as an endpoint in the REGAL trial when announcing future milestones?
**MWN-AI FAQ is based on asking OpenAI questions about SELLAS Life Sciences Group Inc. (NASDAQ: SLS).
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