Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in MRD Testing with clonoSEQ® and Its Impact on Blood Cancer Treatment Decisions
Adaptive Biotechnologies (ADPT) presented new data at the 66th ASH Annual Meeting showcasing the effectiveness of their clonoSEQ® test in measuring residual disease (MRD) for blood cancer treatment. Key findings from multiple studies demonstrate that achieving MRD levels below 10⁻⁶ correlates with improved patient outcomes.
The Phase 3 ECOG-ACRIN EA4151 trial revealed that mantle cell lymphoma patients with undetectable MRD may not need autologous transplantation. The FELIX study showed 84% of treatment responders achieved MRD <10⁻⁶, associated with better survival rates. Additional studies in multiple myeloma, chronic lymphocytic leukemia, and pediatric B-ALL further validated clonoSEQ's utility in guiding treatment decisions and monitoring disease progression.
Adaptive Biotechnologies (ADPT) ha presentato nuovi dati durante il 66° Congresso Annuale ASH, evidenziando l'efficacia del loro test clonoSEQ® nella misurazione della malattia residua (MRD) per il trattamento dei tumori del sangue. I risultati chiave di più studi dimostrano che il raggiungimento di livelli di MRD inferiori a 10⁻⁶ è correlato a migliori esiti per i pazienti.
Lo studio di Fase 3 ECOG-ACRIN EA4151 ha rivelato che i pazienti con linfoma a cellule del mantello e MRD non rilevabile potrebbero non aver bisogno di trapianto autologo. Lo studio FELIX ha mostrato che l'84% dei pazienti che hanno risposto al trattamento ha raggiunto un MRD <10⁻⁶, associato a tassi di sopravvivenza migliori. Ulteriori studi su mieloma multiplo, leucemia linfatica cronica e B-ALL pediatrico hanno ulteriormente convalidato l'utilità del clonoSEQ nel guidare le decisioni terapeutiche e nel monitorare la progressione della malattia.
Adaptive Biotechnologies (ADPT) presentó nuevos datos en la 66.ª Reunión Anual de ASH, mostrando la eficacia de su prueba clonoSEQ® para medir la enfermedad residual mínima (MRD) en el tratamiento del cáncer de sangre. Los hallazgos clave de múltiples estudios demuestran que alcanzar niveles de MRD por debajo de 10⁻⁶ se correlaciona con mejores resultados para los pacientes.
El ensayo de Fase 3 ECOG-ACRIN EA4151 reveló que los pacientes con linfoma de células del manto y MRD indetectable podrían no necesitar un trasplante autólogo. El estudio FELIX mostró que el 84% de los respondedores al tratamiento alcanzaron un MRD <10⁻⁶, asociado con mejores tasas de supervivencia. Estudios adicionales en mieloma múltiple, leucemia linfocítica crónica y B-ALL pediátrico validaron aún más la utilidad de clonoSEQ en la toma de decisiones clínicas y el monitoreo de la progresión de la enfermedad.
Adaptive Biotechnologies (ADPT)는 제66회 ASH 연례 회의에서 혈액암 치료를 위한 잔여 질병(MRD) 측정을 위한 clonoSEQ® 테스트의 효과를 보여주는 새로운 데이터를 발표했습니다. 여러 연구의 주요 결과는 MRD 수준이 10⁻⁶ 이하일 때 환자 결과가 개선된다는 것을 보여줍니다.
3상 ECOG-ACRIN EA4151 시험에서는 MRD가 감지되지 않는 외투세포 림프종 환자들이 자가 이식이 필요하지 않을 수 있다는 점이 밝혀졌습니다. FELIX 연구에서는 치료 반응자의 84%가 MRD <10⁻⁶에 도달했으며, 이는 더 나은 생존율과 관련이 있습니다. 다발골수종, 만성 림프구 백혈병, 소아 B-ALL에 대한 추가 연구는 치료 결정 및 질병 진행 모니터링에서 clonoSEQ의 유용성을 더욱 입증했습니다.
Adaptive Biotechnologies (ADPT) a présenté de nouvelles données lors de la 66e réunion annuelle de l'ASH, mettant en avant l'efficacité de leur test clonoSEQ® pour mesurer la maladie résiduelle minimale (MRD) dans le traitement des cancers du sang. Les résultats clés de plusieurs études montrent que l'atteinte de niveaux de MRD inférieurs à 10⁻⁶ est corrélée à de meilleurs résultats pour les patients.
L'essai de phase 3 ECOG-ACRIN EA4151 a révélé que les patients atteints de lymphome à cellules du manteau avec une MRD indétectable pourraient ne pas avoir besoin de transplantation autologue. L'étude FELIX a montré que 84 % des patients répondant au traitement ont atteint une MRD <10⁻⁶, associée à de meilleurs taux de survie. D'autres études sur le myélome multiple, la leucémie lymphoïde chronique et le B-ALL pédiatrique ont également validé l'utilité de clonoSEQ pour guider les décisions thérapeutiques et surveiller la progression de la maladie.
Adaptive Biotechnologies (ADPT) hat auf dem 66. jährlichen ASH-Treffen neue Daten vorgestellt, die die Wirksamkeit ihres clonoSEQ®-Tests zur Messung der minimalen Resterkrankung (MRD) bei der Behandlung von Blutkrebs zeigen. Wichtige Ergebnisse aus mehreren Studien zeigen, dass das Erreichen von MRD-Werten unter 10⁻⁶ mit besseren Patientenergebnissen korreliert.
Die Phase-3-Studie ECOG-ACRIN EA4151 zeigte, dass Patienten mit Mantelzelllymphom und nicht nachweisbarer MRD möglicherweise keine autologe Transplantation benötigen. Die FELIX-Studie zeigte, dass 84 % der Behandlungsantwortenden MRD <10⁻⁶ erreichten, was mit besseren Überlebensraten assoziiert ist. Weitere Studien bei multiplem Myelom, chronischer lymphatischer Leukämie und pädiatrischer B-ALL haben zusätzlich die Nützlichkeit von clonoSEQ zur Unterstützung von Behandlungsentscheidungen und zur Überwachung des Krankheitsverlaufs validiert.
- Phase 3 trial data shows clonoSEQ can help avoid unnecessary transplantation procedures in MCL patients
- FELIX study demonstrated 84% treatment response rate with MRD <10⁻⁶
- Evidence supports clonoSEQ's effectiveness in early detection of disease progression
- Data validates test's utility in multiple blood cancer types (MCL, CLL, MM, ALL)
- None.
Insights
The data presented at ASH reveals significant breakthroughs in blood cancer treatment using clonoSEQ's MRD testing. The ECOG-ACRIN EA4151 trial shows that patients with undetectable MRD at 10⁻⁶ sensitivity may not need auto-HCT, potentially sparing them from unnecessary intensive treatment. This could lead to substantial cost savings and improved quality of life for MCL patients.
The FELIX study demonstrates impressive efficacy with 84% of treatment responders achieving deep molecular remission (MRD <10⁻⁶), correlating with better survival outcomes. Additionally, the ability to detect MRD progression 10.1 months before clinical progression in MM patients provides a important early warning system for clinicians.
This extensive clinical validation strengthens clonoSEQ's market position as the leading MRD testing platform. The data spanning multiple blood cancers (MCL, CLL, MM, ALL) demonstrates broad utility and potential market expansion. The test's ability to guide treatment decisions, particularly in avoiding costly procedures like auto-HCT, presents a compelling value proposition for healthcare providers and payers.
The integration of clonoSEQ in over 65 abstracts at ASH indicates strong adoption and scientific recognition. This positions Adaptive Biotechnologies favorably for increased market penetration and potential revenue growth as MRD testing becomes standard practice in blood cancer management.
New data demonstrate the actionability of clonoSEQ for tailoring treatment decisions in patients with MCL, CLL, MM and ALL
Studies show depth of response at 10-6 provides more accurate assessment of treatment responses
SEATTLE, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced new data demonstrating the impact of measurable residual disease (MRD) assessment using Adaptive’s next-generation sequencing-based clonoSEQ® test in blood cancer clinical care and drug development. The data are featured in more than 65 abstracts being presented at the 66th Annual Meeting of the American Society of Hematology (ASH), taking place December 6-10 in San Diego.
“At this year's ASH meeting, we're proud to see clonoSEQ's pivotal role in shaping the future of blood cancer care,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “The breadth of data presented highlight the growing recognition of clonoSEQ as a powerful tool for accelerating patient access to novel therapies, optimizing clinical care and delivering actionable insights that improve outcomes for patients living with a variety of blood cancers."
Phase 3 data from the ECOG-ACRIN EA4151 trial indicate that autologous hematopoietic cell transplantation (auto-HCT) may not provide additional benefit for mantle cell lymphoma (MCL) patients in first complete remission (CR) who have undetectable minimal residual disease (uMRD) at a sensitivity of 10⁻⁶. The findings will be presented in a late-breaking abstract titled, Lack of Benefit of Autologous Hematopoietic Cell Transplantation (auto-HCT) in Mantle Cell Lymphoma (MCL) Patients (pts) in First Complete Remission (CR) with Undetectable Minimal Residual Disease (uMRD): Initial Report from the ECOG-ACRIN EA4151 Phase 3 Randomized Trial (Abstract LBA6). Patients in CR with uMRD at 10⁻⁶ sensitivity from peripheral blood were randomized to receive either auto-HCT plus three years of maintenance rituximab (MR) or MR alone. Interim analysis, with a median follow-up of 2.7 years, showed no significant difference in overall survival (OS) between the two groups, suggesting that auto-HCT may be unnecessary for patients achieving deep remission as measured by highly sensitive MRD assessment.
“Our study indicates that highly sensitive MRD testing, such as the clonoSEQ assay that we used, can potentially be used to tailor treatment decisions for patients with MCL,” said Timothy Fenske, M.D., professor, department of medicine, Medical College of Wisconsin. “By identifying patients in first complete remission who also have undetectable MRD status at 10⁻⁶, we can potentially avoid the need for autologous hematopoietic cell transplantation, sparing them the associated risks and burdens. At the same time, patients who remain MRD-positive post-induction may benefit from more intensive consolidation therapy such as auto-HCT to optimize their outcomes.”
Data from the FELIX study indicate that achieving deep molecular remission, defined as MRD levels below 10⁻⁶, correlates with improved outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel. These findings were presented in an oral session titled Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes (Abstract 963). The study found that
“Highly sensitive MRD testing provides a more accurate assessment of treatment response, allowing clinicians to make more informed decisions that can lead to improved long-term outcomes,” said Elias Jabbour, M.D., professor of medicine, department of leukemia, The University of Texas MD Anderson Cancer Center. “The findings from the FELIX study underscore the importance of incorporating highly sensitive MRD testing into routine clinical practice to optimize care for patients.”
Additional Key clonoSEQ Data Presented at the Meeting:
Blinatumomab Added to Chemotherapy Improves Disease-Free Survival in Newly Diagnosed NCI Standard Risk Pediatric B-Acute Lymphoblastic Leukemia: Results from the Randomized Children’s Oncology Group Study AALL1731 (Abstract 1)
- This Phase 3 randomized trial evaluated the addition of blinatumomab to standard chemotherapy in pediatric patients with newly diagnosed standard-risk (SR) B-ALL with average or higher risk of relapse. In the SR average cohort, patients that were MRD positive by clonoSEQ were randomized to receive standard chemotherapy with or without blinatumomab. The study found that incorporating blinatumomab significantly improved disease-free survival compared to chemotherapy alone, establishing a new treatment standard for this patient population.
Implications of MRD Progression in Newly Diagnosed Multiple Myeloma (NDMM) Treated with Quadruplet Therapy and Autologous Stem Cell Transplantation (Abstract 363)
- This study identified 49 newly diagnosed multiple myeloma (MM) patients treated with a quadruplet regimen followed by autologous stem cell transplantation who experienced MRD progression as assessed by clonoSEQ, or disease progression as defined by the International Myeloma Working Group (IMWG). The median time from MRD progression to IMWG-defined disease progression was 10.1 months, supporting that rising MRD levels are an early indicator of impending clinical relapse in MM patients.
Minimal Residual Disease (MRD)-Adapted Duration of Front-Line Venetoclax and Obinutuzumab Treatment for Fit Patients with Chronic Lymphocytic Leukemia (CLL) (Abstract 1010)
- This Phase 2 study evaluating the use of venetoclax and obinutuzumab in treatment-naïve CLL patients found that those achieving undetectable MRD (<10⁻⁶) after nine cycles could discontinue therapy early. These patients had progression-free survival comparable to those who completed the standard 12 cycles, demonstrating the feasibility of MRD-guided treatment duration to minimize therapy exposure without compromising efficacy.
About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ is CE-marked under IVDR in the EU. For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request.
clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The test provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematologic malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL.
For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.
About Adaptive Biotechnologies
Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
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FAQ
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