What is the IMF’s Immune Therapy Registry?
The Immune Therapy Registry, an International Myeloma Working Group (IMWG) research project, is the first global clinical database study to prospectively collect data from patients with relapsed and/or high-risk myeloma receiving immune therapies. Data are collected from the time of diagnosis and are updated every 6 months. The study will include a total of approximately 6,000 patients from various IMF sites worldwide. The database is housed online in a secure password-protected and Food and Drug Administration (FDA)/HIPPA-compliant format with restricted access. A third-party vendor has helped build and will maintain the master electronic database.
This database allows researchers to examine patient and disease characteristics to better understand the best candidates for each novel therapy. Also, it may help researchers to better understand how and in what sequence these immune therapies are best used in practice. The application of these novel therapies and the outcomes achieved will help inform future research and clinical applications. This, in turn, will address an unmet need to identify more effective multiple myeloma treatments to improve patient outcomes. Most importantly, the data will ensure that the right patient is getting the right treatment at the right time.
Where is the IMF’s Immune Therapy Registry active?
The Immune Therapy Registry is a global platform that includes major sites in the United States, Europe, and Asia. One aspect of it is that the assessment of real-world access to the various immune therapies will occur as these therapies receive regulatory approval and can become available with or without reimbursement. Unfortunately, only a few sites outside of the U.S. have both approval and reimbursement in place.
What are currently approved therapies being studied in the Immune Therapy Registry?
Currently, approved agents include belantamab mafodotin (an anti-BCMA monoclonal antibody drug conjugate), which was approved by the FDA in the U.S. until recently. Belantamab mafodotin’s approval was revoked, and it was pulled from the market because a required follow-up trial failed to meet expected endpoints.
In 2023, three agents have been approved and available for assessment: the CAR T-cell therapies of Abecma® (idecabtagene vicleucel, “ide-cel”) and Carvykti™ (ciltacabtagene autoleucel, cilta-cel), as well the anti-BCMA/CD3 bispecific monoclonal antibody known as Tecvayli™ (also known as teclistmab-cqyv, the drug's generic name).
The FDA and European Medicines Agency (EMA) recently approved Teclistamab (TEC) based on the MajesTEC-1 study. This study demonstrated a high overall response rate (ORR) of 63% in heavily pretreated patients with relapsed multiple myeloma. Because TEC has been associated with some unique side effects, including cytokine release syndrome (CRS) and neurotoxicity (ICANS), it is an important agent to evaluate. In addition, TEC has also been associated with a high incidence of infections (76.4% overall: >= grade 3 was 44.8%). This agent is the first to be evaluated as part of the Immune Therapy Registry. It will be possible to study both the responses and toxicities for the first 116 patients enrolled. The results will be submitted for abstract presentation soon.
