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A Sensitive, Accurate, and Standardized Method for MRD Detection and Monitoring

The clonoSEQ® Assay is a robust, highly-validated tool for identifying and monitoring measurable residual disease (MRD) in lymphoid malignancies. Across a variety of large, multi-center clinical trials, clonoSEQ has generated a wealth of peer-reviewed clinical evidence in disease states including multiple myeloma (MM)[1] and B-cell acute lymphoblastic leukemia (ALL).*[2]

Click on the buttons below to review specific data for:

Multiple Myeloma

B-cell Acute lymphoblastic leukemia

MULTIPLE MYELOMA

Clinical Data Myeloma Header

Data Spotlight

peer-reviewed publications demonstrate the benefits of clonoSEQ in Myeloma:

MRD assessment by clonoSEQ predicts time to tumor progression (TTP) and overall survival (OS).[7]

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PROGNOSTIC VALUE

The clonoSEQ Assay has prognostic value in multiple myeloma

Significant difference in 12-month PFS in MRD-negative patients by NGS

A study of 45 patients with smoldering or newly-diagnosed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethazole showed that there was a significant difference in 12-month progression free survival in patients who were MRD-negative versus MRD-positive by NGS (P=0.02).[1]
 

MRD by NGS predicts time to tumor progression and overall survival

A study of 133 patients on GEM clinical trials (GEM00, GEM05, and GEM2010) found that MRD assessment by NGS was prognostic for time to progression (TTP; Figure 4) and overall survival (OS; Figure 5).[7]


• NGS identified two subgroups of CR patients that had significantly different TTP.[7]


• clonoSEQ MRD identified trackable sequences in 121/133 patients (91%).[7]


• There were 82 concordant MRD results between NGS and flow cytometry. There were 17 discordant MRD cases: 12 were NGS MRD-positive and flow MRD-negative; 5 were NGS MRD-negative and flow MRD-positive.

Clinical Data

Figure 4: MRD-negativity by NGS was associated with significantly longer TTP

Clinical Data

Figure 5: MRD-negativity by NGS was associated with significantly longer OS

 

1. Korde N, et al. JAMA Oncol. 2015;1(6):764-754.*
7. Martinez-Lopez J, et al. Blood. 2014;123(20):3073-3079.*

* Study author's research was funded, in part, via product grants from Adaptive.

MRD-negativity at deeper sensitivity correlates with improved outcomes pre- and post-maintenance.

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SENSITIVITY MATTERS

MRD-negativity at deeper sensitivity correlates with improved outcomes pre- and post-maintenance

Better outcomes for patients who achieve lower levels of disease burden (deeper response) pre-maintenance

When assessing MRD by clonoSEQ, pre-maintenance, patients (N=246) were stratified by level of MRD detected (≥10-4, 10-4 – 10-5, 10-5 – 10-6, <10-6). Patients with the deepest level of MRD-negativity (<10-6), had superior PFS compared to clonoSEQ MRD-positive patients with disease >10-6 (P<0.0001, Figure 6).[8]

Clinical Data

Figure 6: Correlation of pre-maintenance MRD, assessed by flow cytometry and clonoSEQ, to PFS


Better outcomes for patients who achieve lower levels of disease burden (deeper response) post-maintenance

When assessing by NGS MRD, patients (N=178) were stratified by level of MRD (≥10-4, 10-4 – 10-5, 10-5 – 10-6, <10-6). Patients with the deepest level of MRD-negativity (<10-6) had superior PFS compared to clonoSEQ MRD-positive patients with disease >10-6 (P<0.0001, Figure 7).[8]

Clinical Data

Figure 7: Correlation of post-maintenance MRD, assessed by flow cytometry and clonoSEQ, to PFS

 

8. Avet Loiseau H, et al. ASH 2015: Abstract 191.*

* Herve Avet-Loiseau acts in a consulting capacity with Adaptive.

clonoSEQ MRD testing identified additional MRD-positive patients who were MRD-negative by flow cytometry.

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ADDITIONAL PATIENTS CAPTURED WITH CLONOSEQ MRD DETECTION

clonoSEQ MRD testing identified additional MRD-positive patients who were MRD-negative by flow cytometry

Additional 84 MRD-positive patients captured pre-maintenance

In a study evaluating MRD in 475 patients, 322 patients had no detectable disease by flow cytometry, of which 163 patients were assessed by clonoSEQ. Of the clonoSEQ-assessed patients, 84 were identified as MRD-positive. These 84 patients had worse PFS compared to patients who had no detectable MRD by flow and were NGS MRD-negative (P=0.0002, Figure 8).[8]

Clinical Data

Figure 8: Pre-maintenance assessment of MRD by NGS in patients who were MRD-negative by flow cytometry


Additional 42 MRD-positive patients captured post-maintenance

Post-maintenance, 232 patients had no detectable MRD by flow cytometry, of which 111 were then assessed by clonoSEQ. Of these 111 patients, 42 were identified as MRD-positive by clonoSEQ. These patients had worse PFS compared to patients who were MRD-negative by flow and clonoSEQ (P=0.0006, Figure 9).[8]

Clinical Data

Figure 9: Post-maintenance assessment of MRD by NGS in patients who were MRD-negative by flow cytometry

 

8. Avet Loiseau H, et al. ASH 2015: Abstract 191.*

* Herve Avet-Loiseau acts in a consulting capacity with Adaptive.

MRD assessment by clonoSEQ predicts time to tumor progression (TTP) and overall survival (OS).[7]

Explore Data

PROGNOSTIC VALUE

The clonoSEQ Assay has prognostic value in multiple myeloma

Significant difference in 12-month PFS in MRD-negative patients by NGS

A study of 45 patients with smoldering or newly-diagnosed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethazole showed that there was a significant difference in 12-month progression free survival in patients who were MRD-negative versus MRD-positive by NGS (P=0.02).[1]
 

MRD by NGS predicts time to tumor progression and overall survival

A study of 133 patients on GEM clinical trials (GEM00, GEM05, and GEM2010) found that MRD assessment by NGS was prognostic for time to progression (TTP; Figure 4) and overall survival (OS; Figure 5).[7]


• NGS identified two subgroups of CR patients that had significantly different TTP.[7]


• clonoSEQ MRD identified trackable sequences in 121/133 patients (91%).[7]


• There were 82 concordant MRD results between NGS and flow cytometry. There were 17 discordant MRD cases: 12 were NGS MRD-positive and flow MRD-negative; 5 were NGS MRD-negative and flow MRD-positive.

Clinical Data

Figure 4: MRD-negativity by NGS was associated with significantly longer TTP

Clinical Data

Figure 5: MRD-negativity by NGS was associated with significantly longer OS

 

1. Korde N, et al. JAMA Oncol. 2015;1(6):764-754.*
7. Martinez-Lopez J, et al. Blood. 2014;123(20):3073-3079.*

* Study author's research was funded, in part, via product grants from Adaptive.

MRD-negativity at deeper sensitivity correlates with improved outcomes pre- and post-maintenance.

Explore Data

SENSITIVITY MATTERS

MRD-negativity at deeper sensitivity correlates with improved outcomes pre- and post-maintenance

Better outcomes for patients who achieve lower levels of disease burden (deeper response) pre-maintenance

When assessing MRD by clonoSEQ, pre-maintenance, patients (N=246) were stratified by level of MRD detected (≥10-4, 10-4 – 10-5, 10-5 – 10-6, <10-6). Patients with the deepest level of MRD-negativity (<10-6), had superior PFS compared to clonoSEQ MRD-positive patients with disease >10-6 (P<0.0001, Figure 6).[8]

Clinical Data

Figure 6: Correlation of pre-maintenance MRD, assessed by flow cytometry and clonoSEQ, to PFS


Better outcomes for patients who achieve lower levels of disease burden (deeper response) post-maintenance

When assessing by NGS MRD, patients (N=178) were stratified by level of MRD (≥10-4, 10-4 – 10-5, 10-5 – 10-6, <10-6). Patients with the deepest level of MRD-negativity (<10-6) had superior PFS compared to clonoSEQ MRD-positive patients with disease >10-6 (P<0.0001, Figure 7).[8]

Clinical Data

Figure 7: Correlation of post-maintenance MRD, assessed by flow cytometry and clonoSEQ, to PFS

 

8. Avet Loiseau H, et al. ASH 2015: Abstract 191.*

* Herve Avet-Loiseau acts in a consulting capacity with Adaptive.

clonoSEQ MRD testing identified additional MRD-positive patients who were MRD-negative by flow cytometry.

Explore Data

ADDITIONAL PATIENTS CAPTURED WITH CLONOSEQ MRD DETECTION

clonoSEQ MRD testing identified additional MRD-positive patients who were MRD-negative by flow cytometry

Additional 84 MRD-positive patients captured pre-maintenance

In a study evaluating MRD in 475 patients, 322 patients had no detectable disease by flow cytometry, of which 163 patients were assessed by clonoSEQ. Of the clonoSEQ-assessed patients, 84 were identified as MRD-positive. These 84 patients had worse PFS compared to patients who had no detectable MRD by flow and were NGS MRD-negative (P=0.0002, Figure 8).[8]

Clinical Data

Figure 8: Pre-maintenance assessment of MRD by NGS in patients who were MRD-negative by flow cytometry


Additional 42 MRD-positive patients captured post-maintenance

Post-maintenance, 232 patients had no detectable MRD by flow cytometry, of which 111 were then assessed by clonoSEQ. Of these 111 patients, 42 were identified as MRD-positive by clonoSEQ. These patients had worse PFS compared to patients who were MRD-negative by flow and clonoSEQ (P=0.0006, Figure 9).[8]

Clinical Data

Figure 9: Post-maintenance assessment of MRD by NGS in patients who were MRD-negative by flow cytometry

 

8. Avet Loiseau H, et al. ASH 2015: Abstract 191.*

* Herve Avet-Loiseau acts in a consulting capacity with Adaptive.

testing

INTERNATIONAL CLINICAL PRACTICE GUIDELINES RECOMMEND MRD TESTING IN MYELOMA

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend MRD testing as a Category 2A recommendation for multiple myeloma patients after each treatment stage (e.g., induction, high-dose therapy/ASCT, consolidation, maintenance) at times of suspected complete response. Next-generation sequencing (NGS) is specifically included in these guidelines among the recommended tools for MRD assessment.[9] International response criteria, including IMWG[6] and ESMO[10], also specifically include MRD negativity by NGS as a measure of disease response in myeloma.

Download Myeloma Clinical Data

Download our Multiple Myeloma clinical data summary to explore and share the data.

Download PDF

Review NCCN Guidelines®

Access the NCCN Guidelines.

GUIDELINES

ACUTE LYMPHOBLASTIC LEUKEMIA

Clinical Data ALL Header

Data Spotlight

Peer-reviewed publications show clear advantages to using clonoSEQ in ALL:

ALL Data

clonoSEQ is concordant with traditional methods for MRD detection and offers increased sensitivity.[14]

Explore Data

CONCORDANCE

THE CLONOSEQ ASSAY IS HIGHLY CONCORDANT WITH TRADITIONAL MRD DETECTION METHODS IN ALL

In a study of more than 100 pediatric ALL patients, the clonoSEQ Assay showed quantitative concordance with both flow cytometry and allelespecific oligonucleotide PCR (ASO-PCR; Figure 2).[14]


INCREASED SENSITIVITY

The clonoSEQ Assay was able to detect additional patients with disease present below the detection limits of flow cytometry (N=10) and ASO-PCR (N=3), respectively (Figure 2, red boxes).[14] ASO-PCR identified one patient with residual disease that was MRD-negative by clonoSEQ.

Clinical Data

Figure 2: Comparison between sequencing and flow cytometry and ASO-PCR. The number of concordant measurements are shown in the lower left and upper right. The number of discordant measurements are shown in the upper left and lower right. Boxed numbers highlight increased sensitivity provided by NGS MRD detection over other methods.

 

14. Faham M, et al. Blood. 2012;120(26):5173-5180.*

* Study author was an employee of Adaptive at time of publishing.
ALL Data

clonoSEQ is shown to be superior to flow cytometry in predicting post treatment relapse and survival.[15]

Explore Data

PREDICTIVE POWER OF CLONOSEQ MRD

clonoSEQ MRD assessment pre-transplant may predict relapse and overall survival

Analysis of pre-transplant bone marrow samples from 41 pediatric patients with ALL found that clonoSEQ MRD detection predicted relapse and overall survival post-allogeneic transplant significantly better than 6-color flow cytometry (Table 2).4[15]


Table 2:

Clinical Data

15. Pulsipher M, et al. Blood. 2015;125(22):3501-8.*

*Study author's research was supported, in part, by product grants from Adaptive.
ALL Data

clonoSEQ can be used to predict relapse and disease free survival in the post-transplant setting.[15]

Explore Data

PROGNOSTIC VALUE

clonoSEQ MRD assessment has demonstrated prognostic value post-transplant in the pediatric and adult ALL settings

Analysis of bone marrow samples from 53 pediatric patients analyzed post-allogeneic transplant showed that clonoSEQ can be used to predict relapse. In the case of discordant MRD determinations, there were 11 patients
identified as clonoSEQ MRD-positive and flow cytometry MRD-negative and 3 patients identified as clonoSEQ MRD-negative and flow cytometry MRD-positive.[15]


Strong predictive power

One month after transplant, flow cytometry was unable to distinguish between patients who ultimately relapsed and those who did not (p=0.91; Figure 3). NGS MRD showed an estimated relapse probability of 67% in MRD-positive patients vs. 25% in MRD-negative patients (p=0.01).[15]

Clinical Data

Figure 3: Flow cytometry (MFC) vs. next-generation sequencing (NGS) MRD +30 days post-transplant


LONG RANGE PREDICTIVE POWER

Better predictive power of post-transplant NGS MRD detection vs. flow cytometry continued at day 100 and 8 months post-transplant.[15]

 

 

15. Pulsipher M, et al. Blood. 2015;125(22):3501-8.*

* Study author's research was supported, in part, by product grants from Adaptive.
ALL Data

clonoSEQ is concordant with traditional methods for MRD detection and offers increased sensitivity.[14]

Explore Data

CONCORDANCE

THE CLONOSEQ ASSAY IS HIGHLY CONCORDANT WITH TRADITIONAL MRD DETECTION METHODS IN ALL

In a study of more than 100 pediatric ALL patients, the clonoSEQ Assay showed quantitative concordance with both flow cytometry and allelespecific oligonucleotide PCR (ASO-PCR; Figure 2).[14]


INCREASED SENSITIVITY

The clonoSEQ Assay was able to detect additional patients with disease present below the detection limits of flow cytometry (N=10) and ASO-PCR (N=3), respectively (Figure 2, red boxes).[14] ASO-PCR identified one patient with residual disease that was MRD-negative by clonoSEQ.

Clinical Data

Figure 2: Comparison between sequencing and flow cytometry and ASO-PCR. The number of concordant measurements are shown in the lower left and upper right. The number of discordant measurements are shown in the upper left and lower right. Boxed numbers highlight increased sensitivity provided by NGS MRD detection over other methods.

 

14. Faham M, et al. Blood. 2012;120(26):5173-5180.*

* Study author was an employee of Adaptive at time of publishing.
ALL Data

clonoSEQ is shown to be superior to flow cytometry in predicting post treatment relapse and survival.[15]

Explore Data

PREDICTIVE POWER OF CLONOSEQ MRD

clonoSEQ MRD assessment pre-transplant may predict relapse and overall survival

Analysis of pre-transplant bone marrow samples from 41 pediatric patients with ALL found that clonoSEQ MRD detection predicted relapse and overall survival post-allogeneic transplant significantly better than 6-color flow cytometry (Table 2).4[15]


Table 2:

Clinical Data

15. Pulsipher M, et al. Blood. 2015;125(22):3501-8.*

*Study author's research was supported, in part, by product grants from Adaptive.
ALL Data

clonoSEQ can be used to predict relapse and disease free survival in the post-transplant setting.[15]

Explore Data

PROGNOSTIC VALUE

clonoSEQ MRD assessment has demonstrated prognostic value post-transplant in the pediatric and adult ALL settings

Analysis of bone marrow samples from 53 pediatric patients analyzed post-allogeneic transplant showed that clonoSEQ can be used to predict relapse. In the case of discordant MRD determinations, there were 11 patients
identified as clonoSEQ MRD-positive and flow cytometry MRD-negative and 3 patients identified as clonoSEQ MRD-negative and flow cytometry MRD-positive.[15]


Strong predictive power

One month after transplant, flow cytometry was unable to distinguish between patients who ultimately relapsed and those who did not (p=0.91; Figure 3). NGS MRD showed an estimated relapse probability of 67% in MRD-positive patients vs. 25% in MRD-negative patients (p=0.01).[15]

Clinical Data

Figure 3: Flow cytometry (MFC) vs. next-generation sequencing (NGS) MRD +30 days post-transplant


LONG RANGE PREDICTIVE POWER

Better predictive power of post-transplant NGS MRD detection vs. flow cytometry continued at day 100 and 8 months post-transplant.[15]

 

 

15. Pulsipher M, et al. Blood. 2015;125(22):3501-8.*

* Study author's research was supported, in part, by product grants from Adaptive.

something

CLINICAL PRACTICE GUIDELINES RECOMMEND MRD TESTING IN ALL:

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for ALL recommend MRD testing at a sensitivity of 10-4 or better because of its clinical utility. Next-generation sequencing (NGS) is listed as one of the recommended methods for MRD assessment in these Guidelines.[16] International response criteria, including ESMO[13], also specifically include MRD negativity by NGS as a measure of disease response in ALL.

Download ALL Clinical Data

Download our Acute Lymphoblastic Leukemia clinical data summary to explore and share the data.

Download PDF

Review NCCN Guidelines®

Access the NCCN Guidelines.

GUIDELINES

 

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Citations

  1. Korde N, et al. JAMA Oncol. 2015;1(6):764-754.
  2. Wu D, et al. Clin Cancer Res. 2014;20(17):4540-8.
  3. Mateos M, et al. N Engl J Med. 2018;378:518-528.
  4. DARZALEX® Prescribing Information. Horsham, PA: Janssen Biotech, Inc; 2018.
  5. Dimopoulos M, et al. N Engl J Med. 2016;375:1319-31.
  6. Kumar S, et al. Lancet Oncol. 2016;17(8):e328-e346.
  7. Martinez-Lopez J, et al. Blood. 2014;123(20):3073-3079.
  8. Avet Loiseau H, et al. ASH 2015: Abstract 191.
  9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines®] for Multiple Myeloma V.3.2017. Accessed May 11, 2017.**
  10. Moreau P, et al. Ann Oncol. 2017;00:1-11.
  11. Kirsch L, et al. SIOP Abstracts. 2016; O-031.
  12. Wood B, et al. Blood. 2018;131(12):1350-1359.
  13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed June 13, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org.**
  14. Faham M, et al. Blood. 2012;120(26):5173-5180. (study author was an employee of Adaptive at time of publishing)
  15. Pulsipher M, et al. Blood. 2015;125(22):3501-8.
  16. Hoelzer D, et al. Ann Oncol. 2016;27 (suppl_5): v69-v82.

*Results generated on the research version of the clonoSEQ Assay. **NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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