A next-generation sequencing (NGS)-based assay called clonoSEQ, being developed by Adaptive Biotechnologies, will be featured at the 61st annual meeting of the American Society of Hematology (ASH) held December 7 – 10, 2019 in Orlando, Florida.
The clonoSEQ assay is the only FDA-cleared test to monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples.
“An unprecedented amount of MRD data are being presented at the ASH annual meeting, demonstrating its established significance as a clinical trial endpoint and a validated measure of patient outcomes in select blood cancers,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies.
“The widespread use of clonoSEQ in clinical research and in patient care underscores the need for a highly sensitive, standardized test that gives patients, clinicians and drug developers confidence in their assessment of MRD status.”
Minimal Residual Disease Testing
Minimal residual disease or MRD is a measure of the amount of cancer in the body, specifically the very small number of cancer cells that remain during or after treatment. MRD testing is performed as a series of tests throughout a patient’s cancer journey to regularly inform treatment decisions. In addition to routine use of MRD as a key endpoint to measure response in research, MRD is being used as an endpoint in clinical trials, and now it is rapidly being incorporated into clinical practice. As MRD measurement continues to inform day-to-day clinical practice, real-world data mounts confirming the outcomes in established in research which includes the ability to assess prognosis, evaluate depth of response to therapy and monitor disease burden over time.
The clonoSEQ assay, the first clinical application of Adaptive’s immune medicine platform, will be featured in a late-breaker presentation, 9 oral presentations and more than 15 posters.
Data on approved, investigational and research uses from studies and real-world experience will be presented across a range of cancers including multiple myeloma, ALL, CLL, and NHLs such as DLBCL, FL and MCL. These new data support the use of NGS MRD testing in multiple disease settings using both bone marrow and blood samples, as well as the important role of MRD monitoring in a real-world clinical setting.
In addition, data will be presented demonstrating the utility of Adaptive’s immune profiling research tool, immunoSEQ® to quantitatively assess the immune response to novel therapies in development.
Key presentations
| Abstract | Title | Date, location, Time |
| Late Breaking | ||
| LBA-6
| Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study Candor | Tuesday, December 10, 2019, 7:30 AM-9:00 AM Hall D, Level 2
|
| Oral Presentations | ||
| 36
| Quantitative Analysis of Minimal Residual Disease (MRD) Shows High Rates of Undetectable MRD after Fixed-Duration Chemotherapy-Free Treatment and Serves As Surrogate Marker for Progression-Free Survival: A Prospective Analysis of the Randomized CLL14 Trial | Saturday, December 7, 2019: 8:45 AM Hall D, Level 2 |
| 357 | Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (iFCG) for First-Line Treatment of IGHV -Mutated CLL and without Del(17p)/Mutated TP53 | Sunday, December 8, 2019: 8:00 AM Hall E1, Level 2 |
| 691
| Depth of Response to Daratumumab (DARA), Lenalidomide, Bortezomib, and Dexamethasone (RVd) Improves over Time in Patients (pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Griffin Study Update | Monday, December 9, 2019: 10:30 AM Hall E1, Level 2
|
| 751
| Minimal Residual Disease (MRD) Assessment in the ECOG1411 Randomized Phase 2 Trial of Front-Line Bendamustine-Rituximab (BR)-Based Induction Followed By Rituximab (R) ± Lenalidomide (L) Consolidation for Mantle Cell Lymphoma (MCL) | Monday, December 9, 2019: 2:45 PM-4:15 PM Hall D, Level 2 |
| 860
| Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd) Induction, Autologous Transplantation and Post-Transplant, Response-Adapted, Measurable Residual Disease (MRD)-Based Dara-Krd Consolidation in Patients with Newly Diagnosed Multiple Myeloma (NDMM) | Monday, December 9, 2019: 4:45 PM Hall E2, Level 2
|
| 884 | Detectable Circulating Tumor DNA 28 Days after the CD19 CAR T-Cell Therapy, Axicabtagene Ciloleucel, Is Associated with Poor Outcomes in Patients with Diffuse Large B-Cell Lymphoma | Monday, December 9, 2019: 4:45 PM W414AB, Level 4 |
| 927 | Updated Results from an Ongoing Phase 1 Clinical Study of bb21217 Anti-Bcma CAR T Cell Therapy | Monday, December 9, 2019: 6:45 PM Valencia A (W415A), Level 4 |
| 602 | Ixazomib or Lenalidomide Maintenance Following Autologous Stem Cell Transplantation and Ixazomib, Lenalidomide, and Dexamethasone (IRD) Consolidation in Patients with Newly Diagnosed Multiple Myeloma: Results from a Large Multi-Center Randomized Phase II Trial | Monday, December 9, 2019: 7:15 PM Sunburst Room (W340) |
| Poster Presentations | ||
| 1758
| Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease By Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL Patients | Saturday, December 7, 2019: 5:30 PM-7:30 PM Hall B, Level 2 |
| 1875
| Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant: Updated Analysis of Maia | Saturday, December 7, 2019: 5:30 PM-7:30 PM Hall B, Level 2
|
| 4291 | High Sensitivity NGS Analysis of MRD in CLL Patients Prospectively Treated with Ibrutinib Plus FCR (iFCR) | Monday, December 9, 2019: 6:00 PM-8:00 PM Hall B, Level 2 |
| 4322 | Minimal Residual Disease Evaluation By Multiparameter Flow Cytometry and Next Generation Sequencing in the Forte Trial for Newly Diagnosed Multiple Myeloma Patients | Monday, December 9, 2019: 6:00 PM-8:00 PM Hall B, Level 2
|
| 4654 | Moffitt Cancer Center 2-Year Single-Institution Experience with Next-Generation Sequencing Minimal Residual Disease Detection: Clinical Utility, Application, and Correlation with Outcomes in Plasma Cell and Lymphoid Malignancies | Monday, December 9, 2019: 6:00 PM-8:00 PM Hall B, Level 2 |
| 4742 | Expanded Meta-Analyses Confirms the Association between MRD and Long-Term Survival Outcomes in Multiple Myeloma (MM) | Monday, December 9, 2019: 6:00 PM-8:00 PM Hall B, Level 2 |
