SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia
SELLAS Life Sciences (NASDAQ: SLS) announced positive interim analysis results for its Phase 3 REGAL trial of GPS in Acute Myeloid Leukemia (AML). The Independent Data Monitoring Committee (IDMC) recommended trial continuation without modifications after reviewing 60 death events. Key findings include:
- Less than 50% of enrolled patients deceased after 13.5 months median follow-up, suggesting survival over 13.5 months versus historical 6 months with conventional therapy
- 80% of randomly selected GPS patients showed specific T-Cell immune response, surpassing previous Phase 2 results
- Final analysis planned upon reaching 80 death events, expected this year
The trial evaluates GPS in AML patients who achieved complete remission following second-line salvage therapy. No drug has been approved specifically for maintenance of remission in AML patients in CR2. The company is preparing for Biologics License Application (BLA) submission.
SELLAS Life Sciences (NASDAQ: SLS) ha annunciato risultati positivi dall'analisi intermedia del suo trial di Fase 3 REGAL per GPS nella Leucemia Mieloide Acuta (LMA). Il Comitato Indipendente per il Monitoraggio dei Dati (IDMC) ha raccomandato la continuazione del trial senza modifiche dopo aver esaminato 60 eventi di decesso. I risultati chiave includono:
- Meno del 50% dei pazienti arruolati è deceduto dopo un follow-up mediano di 13,5 mesi, suggerendo una sopravvivenza oltre i 13,5 mesi rispetto a una media storica di 6 mesi con la terapia convenzionale
- L'80% dei pazienti selezionati casualmente ha mostrato una risposta immunitaria specifica delle cellule T, superando i risultati precedenti della Fase 2
- L'analisi finale è prevista al raggiungimento di 80 eventi di decesso, atteso entro quest'anno
Il trial valuta GPS in pazienti con LMA che hanno raggiunto una remissione completa dopo una terapia salvavita di seconda linea. Nessun farmaco è stato approvato specificamente per il mantenimento della remissione nei pazienti con LMA in CR2. L'azienda si sta preparando per la presentazione della Domanda di Licenza Biologica (BLA).
SELLAS Life Sciences (NASDAQ: SLS) anunció resultados positivos del análisis intermedio de su ensayo de Fase 3 REGAL para GPS en Leucemia Mieloide Aguda (LMA). El Comité Independiente de Monitoreo de Datos (IDMC) recomendó la continuación del ensayo sin modificaciones tras revisar 60 eventos de fallecimiento. Los hallazgos clave incluyen:
- Menos del 50% de los pacientes inscritos fallecieron después de un seguimiento mediano de 13,5 meses, lo que sugiere una supervivencia superior a los 13,5 meses en comparación con los 6 meses históricos con terapia convencional
- El 80% de los pacientes de GPS seleccionados aleatoriamente mostraron una respuesta inmunitaria específica de células T, superando los resultados anteriores de la Fase 2
- Se planea un análisis final tras alcanzar 80 eventos de fallecimiento, que se espera que ocurra este año
El ensayo evalúa GPS en pacientes con LMA que lograron una remisión completa después de la terapia de rescate de segunda línea. No se ha aprobado ningún medicamento específicamente para el mantenimiento de la remisión en pacientes con LMA en CR2. La empresa se está preparando para la presentación de la Solicitud de Licencia Biológica (BLA).
SELLAS Life Sciences (NASDAQ: SLS)는 급성 골수성 백혈병 (AML)에 대한 GPS의 3상 REGAL 시험의 긍정적인 중간 분석 결과를 발표했습니다. 독립 데이터 모니터링 위원회 (IDMC)는 60건의 사망 사건을 검토한 후 시험을 수정 없이 계속 진행할 것을 권장했습니다. 주요 발견 사항은 다음과 같습니다:
- 등록된 환자의 50% 미만이 13.5개월의 중앙 추적 관찰 기간 후 사망하여, 기존 치료로 평균 6개월에 비해 13.5개월 이상 생존한 것으로 나타났습니다.
- 무작위로 선택된 GPS 환자의 80%가 특정 T세포 면역 반응을 보였으며, 이전 2상 결과를 초월했습니다.
- 80건의 사망 사건이 발생하면 최종 분석이 예정되어 있으며, 올해 내에 이루어질 것으로 예상됩니다.
이 시험은 2차 구제 치료 후 완전 관해에 도달한 AML 환자에서 GPS를 평가합니다. CR2에서 AML 환자의 관해 유지에 특별히 승인된 약물은 없습니다. 회사는 생물학적 제품 허가 신청(BLA)을 제출할 준비를 하고 있습니다.
SELLAS Life Sciences (NASDAQ: SLS) a annoncé des résultats positifs d'analyse intermédiaire pour son essai de phase 3 REGAL sur le GPS dans la leucémie myéloïde aiguë (LMA). Le Comité Indépendant de Surveillance des Données (IDMC) a recommandé la poursuite de l'essai sans modifications après avoir examiné 60 événements de décès. Les principaux résultats incluent:
- Moins de 50% des patients inscrits sont décédés après un suivi médian de 13,5 mois, suggérant une survie au-delà de 13,5 mois par rapport aux 6 mois historiques avec un traitement conventionnel
- 80% des patients sélectionnés aléatoirement ayant reçu le GPS ont montré une réponse immunitaire spécifique des cellules T, surpassant les résultats précédents de la phase 2
- L'analyse finale est prévue lorsque 80 événements de décès seront atteints, prévue cette année
L'essai évalue le GPS chez des patients atteints de LMA ayant obtenu une rémission complète après une thérapie de sauvetage de deuxième ligne. Aucun médicament n'a été spécifiquement approuvé pour le maintien de la rémission chez les patients atteints de LMA en CR2. L'entreprise se prépare à soumettre une Demande de Licence Biologique (BLA).
SELLAS Life Sciences (NASDAQ: SLS) hat positive vorläufige Analyseergebnisse für seine Phase-3-Studie REGAL zu GPS bei akuter myeloischer Leukämie (AML) bekannt gegeben. Das Unabhängige Komitee zur Datenüberwachung (IDMC) empfahl, die Studie ohne Änderungen fortzusetzen, nachdem 60 Todesfälle überprüft wurden. Wichtige Ergebnisse sind:
- Weniger als 50% der eingeschlossenen Patienten verstarben nach einer medianen Nachbeobachtungszeit von 13,5 Monaten, was auf eine Überlebenszeit von über 13,5 Monaten im Vergleich zu historischen 6 Monaten mit konventioneller Therapie hindeutet
- 80% der zufällig ausgewählten GPS-Patienten zeigten eine spezifische Immunantwort von T-Zellen, und übertrafen damit die Ergebnisse der vorherigen Phase 2
- Die endgültige Analyse ist geplant, wenn 80 Todesfälle erreicht werden, was in diesem Jahr erwartet wird
Die Studie bewertet GPS bei AML-Patienten, die nach einer zweiten Salvage-Therapie eine vollständige Remission erreicht haben. Keines der Medikamente wurde speziell zur Aufrechterhaltung der Remission bei AML-Patienten in CR2 genehmigt. Das Unternehmen bereitet sich auf die Antragsstellung für eine Biologics License Application (BLA) vor.
- Positive interim analysis results with IDMC recommendation to continue trial without modifications
- Survival data showing >13.5 months median survival vs historical 6 months
- 80% of patients showed specific T-Cell immune response vs 64% in Phase 2
- First potential drug approval for AML maintenance therapy in CR2 patients
- Strong safety profile with minimal side effects compared to standard therapies
- Final trial results still pending 80 death events
- Company remains blinded to specific trial outcomes
Insights
The interim analysis of SELLAS' Phase 3 REGAL trial represents a pivotal moment in AML treatment development. The trial's continuation recommendation by the IDMC is particularly significant for several reasons:
- The survival data is remarkably promising - with fewer than 50% of patients deceased at 13.5 months median follow-up, more than doubling the historical 6-month survival benchmark.
- The 80% GPS-specific immune response rate in randomly selected patients significantly outperforms the Phase 2 study's 64%, suggesting enhanced therapeutic efficacy.
- The trial targets AML patients in second complete remission (CR2), a population with no FDA-approved maintenance therapies, representing a clear first-mover advantage opportunity.
The regulatory implications are substantial. With no currently approved drugs for AML maintenance therapy in CR2 patients, GPS could potentially secure a unique market position. The strong safety profile, coupled with efficacy signals, positions GPS favorably for future regulatory review. The Company's proactive preparation for BLA submission components indicates confidence in the final outcome.
The survival benefit suggested by the interim data could revolutionize AML treatment standards. Historical median survival of 5.4 months with standard care versus 21 months observed in GPS's Phase 2 trial presents a compelling efficacy narrative. If the Phase 3 data continues this trend, GPS could establish a new paradigm in AML maintenance therapy.
The minimal side effect profile reported is particularly noteworthy, especially compared to the 60% severe side effect rate in standard therapies. This favorable safety profile could drive strong market adoption and patient compliance, potentially leading to better real-world outcomes.
- REGAL Successfully Passes Event-Driven (60 Deaths) Interim Analysis for Efficacy, Futility, and Safety: The Independent Data Monitoring Committee (IDMC) Recommended Continuation of the Clinical Trial Without Modification –
- Based on a Review of Unblinded Data, the IDMC Confirmed that GPS Exceeded the Predetermined Futility Criteria, Noted no Safety Concerns and Commended SELLAS for its Operational Excellence and Study Data Integrity -
- Fewer than
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- Next and Final Analysis Planned Upon Reaching 80 Events -
NEW YORK, Jan. 23, 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 Independent Data Monitoring Committee (IDMC) has completed pre-specified interim analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). Following this interim analysis triggered by 60 events (deaths) in the study population, the IDMC has recommended that the trial continue without modifications.
The interim futility, efficacy, and safety analysis is designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC’s review of the interim data supports the continuation of the study according to its original protocol. Based on this positive evaluation, GPS has shown preliminary signals of effectiveness, allowing the trial to advance toward completion. The next and final analysis will be conducted once 80 events (deaths) are reached, further determining the potential of GPS in addressing the needs of AML patients. SELLAS anticipates that 80 events will be reached this year.
“I am thrilled by the positive outcome of the interim analysis of our Phase 3 REGAL trial, marking the successful achievement of the most significant milestone for our GPS program to date. The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval for the treatment of AML,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease. We are optimistic about the IDMC’s recommendation to continue the study without modifications, and diligently preparing for the Biologics License Application (BLA). Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission. We look forward to completing the trial with the final analysis to be conducted once 80 events are reached.”
The Company is blinded to the trial outcomes, following regulations that safeguard study integrity. However, select blinded data has been presented, revealing that fewer than half of the enrolled patients have been confirmed deceased approximately 10 months after completion of enrollment, and an approximate median follow-up of 13.5 months (range 1 month to more than 3 years). This suggested a pooled median survival exceeding 12 months, compared to the expected survival of approximately 6 months in a similar patient population (patients in second complete remission who did not receive a transplant after the second remission). Separately, a blinded analysis of early immune response in a randomly selected sample of patients receiving GPS showed GPS-specific immune response in
These data are consistent with previous GPS trials. In the Phase 2 study in AML patients in second complete remission, the median overall survival of GPS-treated patients was 21 months versus 5.4 months for patients on standard of care therapy and a GPS-specific immune response of
These promising data have encouraged the Company to continue preparations for the preclinical, clinical, manufacturing, and quality assurance components of the BLA regulatory submission in anticipation of final clinical data. No drug has yet been approved specifically for maintenance of remission in AML patients in CR2, further emphasizing the significance of this development.
“The interim results represent a major step forward in the treatment of AML, offering hope for patients in remission,” said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center. “I am very hopeful that we will see a new standard of care in treating AML patients based on the outcomes we have observed in previous GPS trials.”
In his comments during a recent webinar on January 8, Dr. Levy also stated, that he believes “that if approved, GPS would be highly accepted by the medical community and patients, and would become a standard-of-care in this high unmet need population. In addition to efficacy, this is also an extremely well-tolerated therapy. GPS efficacy does not come at the cost of quality of life. GPS has been shown to be very safe, with minimal side effects … This is particularly important, given that up to
REGAL is a Phase 3 open-label 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 (formerly GFH009) - 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 28, 2024 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
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
FAQ
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