SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without Modification
SELLAS Life Sciences (NASDAQ: SLS) announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC's review supports continuing the trial without modifications, confirming GPS's favorable risk-benefit profile.
The study, which completed enrollment in April 2024 with 126 patients, predominantly recruited from U.S. and European sites (75% of total enrollment). The final analysis, expected by year-end, will be triggered when 80 events (deaths) occur, which will determine GPS's potential effectiveness in AML treatment.
SELLAS Life Sciences (NASDAQ: SLS) ha annunciato una raccomandazione positiva da parte del Comitato Indipendente di Monitoraggio dei Dati (IDMC) per lo studio di fase 3 REGAL su galinpepimut-S (GPS) nella leucemia mieloide acuta (AML). La revisione dell'IDMC supporta la continuazione dello studio senza modifiche, confermando il profilo favorevole rischio-beneficio di GPS.
Lo studio, che ha completato il reclutamento ad aprile 2024 con 126 pazienti, principalmente provenienti da siti negli Stati Uniti e in Europa (75% del totale), prevede l'analisi finale entro fine anno al raggiungimento di 80 eventi (decessi), che determinerà l'efficacia potenziale di GPS nel trattamento dell'AML.
SELLAS Life Sciences (NASDAQ: SLS) anunció una recomendación positiva del Comité Independiente de Monitoreo de Datos (IDMC) para su ensayo de fase 3 REGAL con galinpepimut-S (GPS) en leucemia mieloide aguda (LMA). La revisión del IDMC respalda la continuación del ensayo sin modificaciones, confirmando el perfil favorable de riesgo-beneficio de GPS.
El estudio, que completó la inscripción en abril de 2024 con 126 pacientes, reclutados principalmente en sitios de EE.UU. y Europa (75% del total), realizará el análisis final a fin de año al alcanzar 80 eventos (muertes), lo que determinará la posible efectividad de GPS en el tratamiento de la LMA.
SELLAS Life Sciences (NASDAQ: SLS)는 급성 골수성 백혈병(AML) 치료를 위한 갈린페피뮛트-S(GPS)의 3상 REGAL 시험에 대해 독립 데이터 모니터링 위원회(IDMC)로부터 긍정적인 권고를 받았다고 발표했습니다. IDMC의 검토 결과, 시험을 수정 없이 계속 진행하는 것이 적절하며 GPS의 유리한 위험-이익 프로파일을 확인했습니다.
이 연구는 2024년 4월에 126명의 환자 등록을 완료했으며, 주로 미국과 유럽 사이트에서 모집(전체 등록의 75%)되었습니다. 최종 분석은 연말까지 80건의 사건(사망) 발생 시점에 실시되며, 이는 AML 치료에서 GPS의 잠재적 효과를 결정할 것입니다.
SELLAS Life Sciences (NASDAQ : SLS) a annoncé une recommandation positive du Comité Indépendant de Surveillance des Données (IDMC) pour son essai de phase 3 REGAL portant sur le galinpepimut-S (GPS) dans la leucémie myéloïde aiguë (LMA). L'examen par l'IDMC soutient la poursuite de l'essai sans modifications, confirmant le profil bénéfice-risque favorable de GPS.
L'étude, qui a terminé son recrutement en avril 2024 avec 126 patients, principalement recrutés sur des sites aux États-Unis et en Europe (75 % du total), prévoit une analyse finale d'ici la fin de l'année, déclenchée au moment où 80 événements (décès) se seront produits, ce qui déterminera l'efficacité potentielle de GPS dans le traitement de la LMA.
SELLAS Life Sciences (NASDAQ: SLS) gab eine positive Empfehlung des Unabhängigen Datenüberwachungsausschusses (IDMC) für die Phase-3-REGAL-Studie mit Galinpepimut-S (GPS) bei akuter myeloischer Leukämie (AML) bekannt. Die Überprüfung durch das IDMC unterstützt die Fortführung der Studie ohne Änderungen und bestätigt das günstige Risiko-Nutzen-Profil von GPS.
Die Studie, die im April 2024 mit 126 Patienten die Einschreibung abgeschlossen hat, rekrutierte überwiegend an US-amerikanischen und europäischen Standorten (75 % der Gesamtteilnahme). Die abschließende Analyse, die bis Jahresende erwartet wird, wird ausgelöst, wenn 80 Ereignisse (Todesfälle) eingetreten sind, was die potenzielle Wirksamkeit von GPS bei der AML-Behandlung bestimmen wird.
- Positive IDMC recommendation to continue the Phase 3 trial without modifications
- No safety concerns identified in the trial
- Efficacy data consistent with expectations
- Strong enrollment completion with 126 patients
- Broad geographic reach with 75% enrollment from US and Europe
- Final analysis dependent on 80 patient deaths, which hasn't been reached yet
- Timeline uncertainty for reaching required event threshold
- Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events -
NEW YORK, Aug. 07, 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 announced that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), and has issued a positive recommendation to continue the trial without modification.
The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct.
The study completed enrollment in April 2024, with a total of 126 patients randomized. Study sites in the U.S. and Europe accounted for approximately
The Phase 3 REGAL trial is a survival-driven study, and the next and final analysis will be triggered once 80 events (deaths) have occurred, further determining the potential of GPS in addressing the needs of AML patients. As of the time of this IDMC review, that threshold has not yet been reached.
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
jfraunces@lifesciadvisors.com
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