Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2024
Autolus Therapeutics (NASDAQ: AUTL) presented clinical data updates at ASH 2024, featuring one oral and three poster presentations about obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
The FELIX trial demonstrated that obe-cel treatment achieved deep molecular remission in 84% of responders, correlating with improved event-free survival and overall survival. The study showed that lower tumor burden at lymphodepletion yielded the best survival benefits.
Additional findings revealed that bridging therapies were effective with obe-cel, maintaining its expansion and persistence. The treatment showed low incidence of severe adverse events, potentially reducing healthcare resource utilization costs. A new CAR-HEMATOTOX risk score was identified as a useful tool for patient risk stratification.
Autolus Therapeutics (NASDAQ: AUTL) ha presentato aggiornamenti sui dati clinici all'ASH 2024, inclusi un intervento orale e tre presentazioni poster riguardanti obecabtagene autoleucel (obe-cel) per la leucemia linfoblastica acuta a cellule B in recidiva/refrattaria (R/R B-ALL).
Il trial FELIX ha dimostrato che il trattamento con obe-cel ha raggiunto una profonda remissione molecolare nell'84% dei rispondenti, correlata a un miglioramento della sopravvivenza libera da eventi e della sopravvivenza complessiva. Lo studio ha indicato che un carico tumorale più basso durante la linfodeplezione ha fornito i migliori vantaggi in termini di sopravvivenza.
Ulteriori risultati hanno rivelato che le terapie ponte sono risultate efficaci con obe-cel, mantenendo la sua espansione e persistenza. Il trattamento ha mostrato una bassa incidenza di eventi avversi gravi, riducendo potenzialmente i costi di utilizzo delle risorse sanitarie. Un nuovo punteggio di rischio CAR-HEMATOTOX è stato identificato come strumento utile per la stratificazione del rischio dei pazienti.
Autolus Therapeutics (NASDAQ: AUTL) presentó actualizaciones de datos clínicos en ASH 2024, con una presentación oral y tres pósters sobre obecabtagene autoleucel (obe-cel) para la leucemia linfoblástica aguda de células B en recaída/refractaria (R/R B-ALL).
El ensayo FELIX demostró que el tratamiento con obe-cel logró una profunda remisión molecular en el 84% de los respondedores, correlacionándose con una mejor supervivencia libre de eventos y supervivencia global. El estudio mostró que una menor carga tumoral durante la linfodepleción obtuvo los mejores beneficios de supervivencia.
Hallazgos adicionales revelaron que las terapias puente fueron efectivas con obe-cel, manteniendo su expansión y persistencia. El tratamiento mostró una baja incidencia de eventos adversos graves, lo que podría reducir los costos de utilización de recursos de atención médica. Se identificó una nueva puntuación de riesgo CAR-HEMATOTOX como una herramienta útil para la estratificación del riesgo del paciente.
Autolus Therapeutics (NASDAQ: AUTL)는 ASH 2024에서 obecabtagene autoleucel (obe-cel)을 사용한 재발/내성 B-세포 급성 림프구 백혈병(R/R B-ALL)에 관한 구두 발표 하나와 포스터 발표 세 개를 포함하여 임상 데이터 업데이트를 발표했습니다.
FELIX 시험은 obe-cel 치료가 응답자의 84%에서 깊은 분자적 관해를 달성했으며, 이는 사건 발생 없는 생존율 및 전체 생존율의 개선과 관련이 있음을 보여주었습니다. 연구는 림프비우기 동안 낮은 종양 부담이 최고의 생존 혜택을 가져온다는 것을 나타냈습니다.
추가 발견은 bridging therapy가 obe-cel과 함께 효과적이었으며, 그 확장성과 지속성을 유지한다는 것을 보여주었습니다. 이 치료는 심각한 부작용의 발생률이 낮아 의료 자원 사용 비용을 줄일 수 있었습니다. 새로운 CAR-HEMATOTOX 위험 점수가 환자 위험 분류를 위한 유용한 도구로 식별되었습니다.
Autolus Therapeutics (NASDAQ: AUTL) a présenté des mises à jour de données cliniques lors de l'ASH 2024, comprenant une présentation orale et trois affiches sur le obecabtagène autoleucel (obe-cel) pour la leucémie aiguë lymphoblastique à cellules B en rechute/résistante (R/R B-ALL).
Le essai FELIX a démontré que le traitement par obe-cel a atteint une profonde rémission moléculaire chez 84 % des répondants, corrélée à une amélioration de la survie sans évènement et de la survie globale. L'étude a montré qu'une charge tumorale plus basse lors de la lymphodéplétion offrait les meilleurs bénéfices en termes de survie.
Des résultats supplémentaires ont révélé que les thérapies de pont étaient efficaces avec obe-cel, maintenant son expansion et sa persistance. Le traitement a montré une faible incidence d'événements indésirables graves, ce qui pourrait potentiellement réduire les coûts d'utilisation des ressources de santé. Un nouveau score de risque CAR-HEMATOTOX a été identifié comme un outil utile pour la stratification des risques des patients.
Autolus Therapeutics (NASDAQ: AUTL) stellte beim ASH 2024 klinische Datenupdates vor, die eine mündliche Präsentation und drei Posterpräsentationen zu obecabtagene autoleucel (obe-cel) für rezidivierte/refraktäre B-Zell-akute lymphoblastische Leukämie (R/R B-ALL) beinhalteten.
Die FELIX-Studie zeigte, dass die Behandlung mit obe-cel bei 84 % der Ansprechenden eine tiefe molekulare Remission erreichte, was mit einer verbesserten ereignisfreien Überlebensdauer und Gesamtüberlebenszeit korrelierte. Die Studie ergab, dass eine niedrigere Tumorlast bei der Lymphodepletion die besten Überlebensvorteile ergab.
Zusätzliche Ergebnisse zeigten, dass Brückentherapien mit obe-cel effektiv waren und dessen Expansion und Persistenz aufrechterhielten. Die Behandlung wies eine geringe Inzidenz schwerer unerwünschter Ereignisse auf, was potenziell die Kosten für den Einsatz von Gesundheitsressourcen senken könnte. Ein neuer CAR-HEMATOTOX-Risikoscore wurde als nützliches Werkzeug zur Risikostratifizierung von Patienten identifiziert.
- High remission rate with 84% of responders achieving deep molecular remission
- Demonstrated correlation between deep remission and improved survival outcomes
- Effective combination with various bridging therapies
- Low incidence of Grade ≥3 CRS and ICANS adverse events
- Potential for reduced healthcare resource utilization costs
- Patients with high-risk CAR-HEMATOTOX scores showed worse outcomes
- Higher costs associated with severe adverse events management
- Treatment outcomes dependent on disease burden at lymphodepletion
Insights
The clinical data presented at ASH reveals significant progress for obe-cel in treating relapsed/refractory B-ALL. The 84% deep molecular remission rate is particularly impressive, indicating strong efficacy. Key findings show that lower tumor burden at lymphodepletion correlates with better survival outcomes, while bridging therapy with inotuzumab ozogamicin effectively reduces disease burden pre-treatment.
The safety profile stands out with low rates of severe CRS and ICANS compared to other CAR-T therapies, potentially reducing healthcare costs and improving the risk-benefit ratio. The development of the CAR-HEMATOTOX risk score provides a valuable tool for patient stratification, enabling better prediction of treatment outcomes.
The positive clinical data strengthens obe-cel's commercial potential in the competitive CAR-T therapy market. The demonstrated lower incidence of severe adverse events could translate into significant cost advantages, both for healthcare systems and Autolus's market positioning. The correlation between deep molecular remission and improved survival outcomes provides compelling evidence for payers and could support favorable reimbursement decisions.
For investors, these results reinforce obe-cel's potential as a best-in-class therapy. The real-world data and healthcare resource utilization insights are particularly valuable for commercial success, as they address key concerns about CAR-T therapy costs and implementation.
LONDON, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces an oral presentation and three poster presentations at the American Society of Hematology (ASH) Annual Meeting, being held from December 7-10, 2024, in San Diego.
“Our oral presentation at ASH this year with data from the FELIX trial demonstrates that obe-cel treatment produces a high incidence of deep molecular remission in r/r adult ALL patients, which correlates with better outcomes and is associated with longer event free survival (EFS) and overall survival (OS),” said Dr. Christian Itin, Chief Executive Officer of Autolus. “We’re also presenting three posters that aim to further our understanding of the use of obe-cel in a real-world context, suggesting the positive clinical outcomes of obe-cel even after effective bridging therapy; the reduced healthcare resource utilization costs associated with lower severity of ICANS and CRS; and how hematotoxicity scores could help identify patients who are at higher risk for hematotoxicity from treatment with obe-cel.”
Abstract 194508 - Oral presentation:
Title: Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes
Session Name: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Risk Stratification and CAR-T Therapies
Session date and time: Monday, December 9, 2024. 4:30 PM - 6:00 PM PT
Presentation Time: 5:00 PM
Session room: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 5-6
Publication Number: 963
Presenting Author: Dr. Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX
Summary: Obe-cel treatment produces a high incidence of deep remission, which is predictive of better clinical outcomes. The majority of responders to obe-cel achieved deep remission to MRD <10–6 level (
Abstract 201514 – Poster presentation:
Title: Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in the Open-Label, Multi-Center, Global, Single-Arm, Phase Ib/II FELIX study: The Impact of Bridging Therapies on CAR T-Cell Expansion and Persistence
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials & Toxicities: Poster II
Session date and time: Sunday December 8, 2024; 6:00 PM - 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 3458
Presenting Author: Dr. Jae H Park, Leukemia Specialist & Cellular Therapist, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Summary: Comparable expansion and long-term persistence of obe-cel was observed with all the bridging therapies evaluated, suggesting that long-term persistence of obe-cel is possible irrespective of the bridging therapy and independent of disease burden at lymphodepletion. Bridging therapy with inotuzumab ozogamicin was effective in reducing disease burden prior to lymphodepletion and obe-cel infusion. Reduction in disease burden at lymphodepletion through bridging therapy led to improved event-free survival and overall survival compared to bridging therapy without INO and maintained a tolerable safety profile.
Abstract 205694 – Poster presentation:
Title: Healthcare Resource Utilization and Costs Associated with Managing CRS and ICANS in Patients with Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia Receiving Obecabtagene autoleucel (obe-cel)
Session Title: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Session date and time: Monday December 9, 2024; 6:00 PM - 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 4837
Presenting Author: Dr. Bijal D Shah, Associate Member in the Department of Malignant Hematology Moffitt Cancer Center, Tampa, FL, USA
Summary: Grade ≥3 cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) are associated with increased healthcare resource utilization (HCRU) and costs, but these events were rare in the FELIX study. Costs for adverse events generally increase with event severity. Medication usage and intensive care unit costs were key drivers of CRS and/or ICANS management costs. Obe-cel has the potential to optimize utilization of resources and reduce costs associated with CAR T-cell therapy for patients with R/R B-ALL as a result of the low incidence of Grade ≥3 CRS and/or ICANS.
Abstract 208028 – Poster presentation:
Title: Risk Factors Associated with Sub-Optimal Outcomes Following Obecabtagene autoleucel (obe-cel) for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): What We Have Learned from the FELIX Trial
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials & Toxicities: Poster III
Session date and time: Monday, December 9, 2024; 6:00 PM - 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 4845
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)
Summary: The CAR-HEMATOTOX risk score correlated with disease burden in this patient population - patients with high-risk CAR-HEMATOTOX scores had consistently worse outcomes than patients with low-risk CAR-HEMATOTOX scores. Risk-stratification, using pre-lymphodepletion clinical parameters together with disease burden, has the potential to be a useful tool for identifying patients at a high risk for hematotoxicity who may benefit from obe-cel treatment.
About Autolus Therapeutics plc
Autolus is a biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has an FDA approved product and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com
About obe-cel FELIX clinical trial
Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint in the pivotal cohort was overall response rate, and the secondary endpoints included duration of response, MRD negative complete remission rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660].
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus’ development and commercialization of its products and product candidates. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.
Contact:
Amanda Cray
+1 617-967-0207
a.cray@autolus.com
Olivia Manser
+44 (0) 7780 471 568
o.manser@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
FAQ
What were the key findings of Autolus Therapeutics' (AUTL) FELIX trial presented at ASH 2024?
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What is the significance of the CAR-HEMATOTOX score in Autolus' (AUTL) obe-cel treatment?
