There is no cure for multiple myeloma, and it is a difficult condition to treat given the potential for relapse and resistance to therapy. That’s why we’re pursuing advances for patients through the MagnetisMM studies. If determined to have a manageable safety profile and proven efficacy, elranatamab could potentially address an unmet clinical need.
BCMA
B-cell maturation antigen (BCMA) is a particularly promising target for cell-directed therapy as this protein is uniquely found on the surface of plasma cells and is nearly non-existent on surrounding naïve and memory B cells.
Additionally, BCMA overexpression on plasma cells and BCMA activation are associated with the progression of multiple myeloma, creating a useful biomarker for this investigational targeted therapy.
Click below to view a video on BCMA as a target for multiple myeloma treatment
Elranatamab
Elranatamab, administered by SC injection, works by binding to both BCMA proteins on cancerous plasma cells and CD3 receptors on the surface of a patient’s own T-cells. Elranatamab bridges these cells together, ultimately aiming to activate an immune response to kill the cancer cells.
The FDA approved Elranatamab in August 2023 for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a protease inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
CD3, T-cell cluster of differentiation 3; CD38, T-cell cluster of differentiation 38; FDA, Food and Drug Administration; SC, subcutaneous
Study design
The study design will vary depending on the MagnetisMM study. Eligible patients will either receive the study medicine (alone or in combination with other agent(s)) or a comparator medicine.
Key eligibility
The MagnetisMM studies are enrolling patients aged 18 years or older who have been diagnosed with multiple myeloma. Each study will have its own unique eligibility requirements, which may include:
- The stage of the patient’s multiple myeloma
- Previous treatments that the patient has received
- How the patient’s multiple myeloma responded to those treatments
MagnetisMM Studies: Now Enrolling
MagnetisMM-5 - Enrolling
Summary
MagnetisMM-5 is a 3-part study to evaluate the safety and efficacy of elranatamab monotherapy versus standard of care (daratumumab, pomalidomide, dexamethasone) and to evaluate the safety and efficacy of elranatamab in combination with daratumumab. Part 3 is currently enrolling.
Primary objectives
- Part 1 - To assess DLTs, safety, and tolerability of elranatamab + daratumumab to select a RP3D for the combination.
- Part 2 – To compare the efficacy of elranatamab vs daratumumab + pomalidomide + dexamethasone as measured by PFS.
- Part 3 – To assess the safety of elranatamab and elranatamab + daratumumab with increased risk minimization for serious infection, including required infection prophylaxis.
Key eligibility criteria
- Aged ≥18 years and a prior diagnosis of multiple myeloma
- Adequate hepatic, renal, bone marrow and cardiovascular function
- Prior treatment with lenalidomide
- No prior treatment with a BCMA-directed therapy or a CD3-redirecting therapy
BCMA, B-cell maturation antigen; CD3, cluster of differentiation 3; DLT, dose-limiting toxicity; PFS, progression-free survival; RP3D, recommended Phase 3 dose
MagnetisMM-30 - Enrolling
Summary
MagnetisMM-30 is a 2-part, open-label study researching elranatamab with iberdomide in patients with multiple myeloma that has come back after responding to treatment
Primary objectives
- Part 1 – To assess safety and tolerability of elranatamab in combination with iberdomide in participants with RRMM in order to select RDEs for the combination (dose optimization part 2).
- Part 2 – To evaluate the overall safety profile of elranatamab in combination with iberdomide./p>
Key eligibility criteria
- Aged ≥18 years and have a prior diagnosis of multiple myeloma
- Relapsed or refractory to the last line of anti-multiple myeloma regimen
- Have received prior treatment with lenalidomide and/or pomalidomide
- Have received prior treatment with at least one proteasome inhibitor
- Have adequate hepatic, renal, and cardiovascular function
RDE, recommended doses for expansion; RRMM, relapsed/refractory multiple myeloma
Together we can make a difference
People are often introduced to the world of research studies through conversations with their healthcare provider. As with anything new, there may be a number of questions, concerns, or misconceptions. Being their trusted healthcare provider, we appreciate you taking the time to have an open discussion with patients and their loved ones who may be interested in contributing to research.
Research studies may be an option that your patients will want to consider. While no benefit is guaranteed from an investigational medicine, your patients who participate in a research study will contribute to the process of developing a potential new therapy.
If you would like more study-specific information to help inform conversations with potential participants, please let us know. Should any of your patients take part in one of the MagnetisMM studies, they will remain under your medical care for all non-study-related needs and will continue to receive any benefits to which they are entitled.
To keep the line of communication open between you and your patients, feel free to follow up with them to see if they are randomized into one of the MagnetisMM studies and to keep in touch with them throughout their study journey.
Pfizer will give MagnetisMM participants the option to access certain individual data, approximately 12 months after study completion. This allows participants to share data with their healthcare provider after their study participation concludes.