SELLAS Life Sciences to Present at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024
SELLAS Life Sciences (NASDAQ: SLS) announced promising results from its Phase 2a trial of SLS009, a CDK9 inhibitor, in treating relapsed/refractory acute myeloid leukemia (r/r AML). The findings will be presented at the 66th ASH Annual Meeting in December 2024.
The trial, involving 30 patients, demonstrated a 50% response rate at the optimal dose level of 30 mg twice weekly. Notable outcomes include a median overall survival of 5.5 months at 45 mg once weekly, compared to less than 2.5 months with standard care. The treatment showed particular effectiveness in patients with AML-myelodysplasia-related changes, especially those with ASXL1 mutations, achieving a 56% response rate in this group.
SELLAS Life Sciences (NASDAQ: SLS) ha annunciato risultati promettenti dal suo studio di Fase 2a su SLS009, un inibitore del CDK9, nel trattamento della leucemia mieloide acuta recidivante/resistente (r/r AML). I risultati saranno presentati alla 66ª Conferenza Annuale ASH nel dicembre 2024.
Lo studio, che ha coinvolto 30 pazienti, ha dimostrato un tasso di risposta del 50% al dosaggio ottimale di 30 mg due volte a settimana. Tra i risultati degni di nota si evidenzia una sopravvivenza globale mediana di 5,5 mesi a 45 mg una volta a settimana, rispetto a meno di 2,5 mesi con la cura standard. Il trattamento ha mostrato particolare efficacia nei pazienti con cambiamenti legati all’AML-mielodisplasia, in particolare in quelli con mutazioni ASXL1, raggiungendo un tasso di risposta del 56% in questo gruppo.
SELLAS Life Sciences (NASDAQ: SLS) anunció resultados prometedores de su ensayo de Fase 2a con SLS009, un inhibidor de CDK9, en el tratamiento de la leucemia mieloide aguda en recaída/resistente (r/r AML). Los hallazgos se presentarán en la 66ª Reunión Anual de ASH en diciembre de 2024.
El ensayo, que involucró a 30 pacientes, demostró una tasa de respuesta del 50% en el nivel de dosis óptimo de 30 mg dos veces por semana. Resultados destacados incluyen una supervivencia global mediana de 5.5 meses con 45 mg una vez por semana, en comparación con menos de 2.5 meses con el tratamiento estándar. El tratamiento mostró una eficacia particular en pacientes con cambios relacionados con AML-mielodisplasia, especialmente en aquellos con mutaciones ASXL1, alcanzando una tasa de respuesta del 56% en este grupo.
SELLAS Life Sciences (NASDAQ: SLS)는 재발/불응성 급성 골수성 백혈병(r/r AML) 치료를 위한 CDK9 억제제인 SLS009의 2a상 시험에서 유망한 결과를 발표했습니다. 이 결과는 2024년 12월에 열리는 제66회 ASH 연례 회의에서 발표될 예정입니다.
30명의 환자가 포함된 이 시험에서는 주 2회 30mg의 최적 용량에서 50%의 반응률이 나타났습니다. 주 1회 45mg에서는 5.5개월의 중간 전체 생존 기간이 나타났으며, 이는 표준 치료로 2.5개월 미만과 비교됩니다. 이 치료는 AML-골수이형성 증후군과 관련된 변화가 있는 환자, 특히 ASXL1 변이를 가진 환자에게서 특히 효과적이었으며, 이 그룹에서 56%의 반응률을 달성했습니다.
SELLAS Life Sciences (NASDAQ: SLS) a annoncé des résultats prometteurs de son essai de phase 2a sur SLS009, un inhibiteur de CDK9, dans le traitement de la leucémie aiguë myéloïde en rechute/résistante (r/r AML). Les résultats seront présentés lors de la 66e réunion annuelle de l'ASH en décembre 2024.
L'essai, impliquant 30 patients, a démontré un taux de réponse de 50% au niveau de dose optimal de 30 mg deux fois par semaine. Parmi les résultats notables, une survie globale médiane de 5,5 mois à 45 mg une fois par semaine a été observée, contre moins de 2,5 mois avec les soins standard. Le traitement a montré une efficacité particulière chez les patients présentant des changements liés à l’AML-mélodysplasie, notamment chez ceux ayant des mutations ASXL1, atteignant un taux de réponse de 56% dans ce groupe.
SELLAS Life Sciences (NASDAQ: SLS) hat vielversprechende Ergebnisse aus seiner Phase 2a-Studie zu SLS009, einem CDK9-Inhibitor, zur Behandlung von rezidivierenden/resistenten akuten myeloischen Leukämien (r/r AML) bekannt gegeben. Die Ergebnisse werden auf dem 66. ASH-Jahrestreffen im Dezember 2024 präsentiert.
Die Studie umfasste 30 Patienten und zeigte eine Antwortquote von 50% bei der optimalen Dosierung von 30 mg zweimal wöchentlich. Hervorzuheben sind eine mediane Gesamtüberlebenszeit von 5,5 Monaten bei 45 mg einmal wöchentlich, verglichen mit weniger als 2,5 Monaten bei der Standardbehandlung. Die Behandlung erwies sich als besonders effektiv bei Patienten mit AML-myelodysplastischen Veränderungen, insbesondere bei solchen mit ASXL1-Mutationen, mit einer Antwortquote von 56% in dieser Gruppe.
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- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure –
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- 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached -
NEW YORK, Nov. 05, 2024 (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 data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held on December 7 –10, 2024, in San Diego, California.
“We are excited to have SLS009 featured at the 2024 ASH meeting and are pleased with the very promising safety and efficacy results from the Phase 2a trial in r/r AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a
Poster presentation details:
| Title: | Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment | |
| Session Date and Time: | Sunday, December 8, 2024, 6:00 PM - 8:00 PM PST | |
| Session Title: | Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II | |
| Location: | San Diego Convention Center, Halls G-H | |
| Lead Author: | Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC | |
| Abstract Number: | 2877 | |
The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (
For more information on the study, visit clinicaltrials.gov identifier NCT04588922.
The accepted abstract is published and available on the ASH website here.
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
FAQ
What were the response rates for SLS009 in the Phase 2a trial for r/r AML?
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