For predicting the response of Newly Diagnosed Multiple Myeloma patients to first-line therapy

An LDT prognostic solution in development and validation in collaboration with Mayo Clinic and Dana Farber Cancer Institute

Management of Newly Diagnosed Multiple Myeloma

  • Newly diagnosed multiple myeloma (NDMM) is treated with a combination therapy of antibodies targeting myeloma cells, immunomodulatory agents, proteasome inhibitors, and dexamethasone. Therapy is followed by autologous stem cell transplantation (ASCT) for eligible patients. Maintenance therapy is commonly used post-transplant or after initial treatment to sustain remission once the tumor burden is reduced.
  • In current clinical practice, patients will remain on a specific treatment regimen until relapse is detected and then be switched to an alternative regimen. The cost of therapy can range between $100,000 - 150,000 per year, making paying for ineffective treatment financially toxic.
  • The duration of the treatment response is heterogenous. The majority of NDMM patients will develop resistance to their treatment and have a relapse event within the first 24 months, 50% of these patients relapse in the first 12 months.
With a good initial treatment response life expectancy of a Newly Diagnosed Multiple Myeloma patient is now longer than 5 years.

Predicting NDMM patient response to first line therapy is an important clinical need. Physicians lack a tool to make informed decisions to switch high-risk patients to an alternative treatment proactively and avoid the relapse event.

The TeloViewNDMM assay has the potential to benefit over 35,000 NDMM patients annually in the US with over 180,000 individual living with MM at any time predicting a total addressable market of approximately 300,000 tests per year.

TeloView® Assay for Newly Diagnosed Multiple Myeloma - TeloViewNDMM

  • The Telo Genomics platform, TeloView®, characterizes disease associated genomic instability by measuring the 3D structure and spatial organization of telomeres.
  • The TeloViewNDMM assay is an application of TeloView® that quantifies individual patients’ risk of relapsing on the first-line MM therapy. It is applied as a high specificity-sensitivity binary classifier:
  • The test predicts if a patient is at high risk of relapse within 1 year of standard first-line therapy, or if they can achieve stable remission for 3 years with first-line therapy.
  • High-risk of relapse MM patients could benefit from;
  • a more intensive first-line therapy at induction or maintenance,
  • alternative first- line regimens or tandem (double) transplant
  • a proactive switching to second-line therapy
  • referral to clinical trial
  • triaged to more advanced treatment modalities like bispecific immunotherapy or CAR-T therapy
  • Low-risk patients may continue with standard treatment but recommended to be regularly monitored using TeloViewNDMM every 4-6 months.

Clinical Validation of TeloViewNDMM

  • Telo Genomics has been validating TeloViewNDMM in collaboration with the Mayo Clinic. TeloView data from 174 NDMM patients were employed as a training dataset to identify significant predictors and develop a predictive scoring model. The results were presented at the 2023 European Hematology Association conference, a major international hematological malignancies conference (TeloViewNDMM, EHA2023).
  • Another trial is underway conducting a blind validation of the developed predictive scoring model. The validation is in collaboration with the Mayo Clinic. This will be a final step to enable adding the TeloViewNDMM test as a Laboratory Developed Test (LDT) on Telo’s CAP/ CLIA and ISO approved testing menu.