Adaptive Biotechnologies Corporation unveiled significant findings at the 66th Annual Meeting of the American Society of Hematology (ASH), showcasing the transformative role of its FDA-cleared clonoSEQ® test for measurable residual disease (MRD) assessment in blood cancers. Over 65 abstracts presented underscore clonoSEQ’s utility in optimizing clinical care, accelerating drug development, and improving outcomes in hematologic malignancies.
Key findings include data from the Phase 3 ECOG-ACRIN EA4151 trial, where highly sensitive MRD testing (10⁻⁶ sensitivity) indicated that autologous hematopoietic cell transplantation (auto-HCT) may not be necessary for mantle cell lymphoma (MCL) patients in first complete remission (CR) with undetectable MRD (uMRD). The trial showed no significant overall survival difference between patients receiving auto-HCT with maintenance rituximab (MR) and those treated with MR alone, suggesting MRD testing could spare some patients the risks and burdens of transplantation.
In the FELIX study, adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel showed improved outcomes when achieving MRD levels below 10⁻⁶. Patients with deeper MRD remission exhibited higher event-free survival and overall survival compared to those with higher MRD levels, emphasizing the prognostic power of clonoSEQ.
Further, the AALL1731 trial in pediatric B-ALL demonstrated that adding blinatumomab to standard chemotherapy significantly improved disease-free survival for MRD-positive patients, establishing a new treatment standard. Studies in chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) also highlighted clonoSEQ’s ability to guide treatment duration and predict disease progression, respectively.
clonoSEQ is the first FDA-cleared in vitro diagnostic (IVD) for MRD detection in multiple myeloma, B-ALL, and CLL, and is offered as a laboratory-developed test (LDT) for diffuse large B-cell lymphoma and mantle cell lymphoma. Leveraging Adaptive’s immune medicine platform, clonoSEQ identifies and quantifies malignant DNA sequences, delivering sensitive and standardized MRD measurements. These insights enable clinicians to assess treatment response, monitor disease burden, and detect relapses early. Clinical guidelines recognize MRD status as a reliable predictor of outcomes, reinforcing clonoSEQ’s role in personalized care. By improving decision-making and tailoring treatments, clonoSEQ continues to redefine blood cancer management and enhance patient outcomes.