What is Abecma?
Abecma, also known as idecabtagene vicleucel or ide-cel, is a first-in-class B-cell maturation antigen (BCMA)-directed personalized immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. Abecma is manufactured by Bristol Myers Squibb.
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Uses
How is Abecma used?
Abecma is used for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.What types of patients can benefit from Abecma?
In a phase 2 clinical trial, Abecma was shown to be effective in:- Patients who received at least four prior therapies
- Patients who were refractory to their previous treatment(s)
- Patients who previously received high-dose chemotherapy and stem cell transplant
How does Abecma work?
Abecma is manufactured using a patient’s T cells that have been collected from their blood. The T cells are modified in a lab to recognize BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. CAR T cells are then infused back into the patient and able to find and kill myeloma cells.
Dosing and Administration
How is Abecma administered?
Abecma is given intravenously (IV) as a one-time infusion of 300 to 460 × 106 CAR T-cells two days after completing lymphodepleting chemotherapy (cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV for three days).
Side Effects
What are Abecma side effects?
The most common side effects seen in a clinical study with Abecma included:- Low neutrophil counts (neutropenia)
- Low leukocyte counts (leukopenia)
- Low lymphocyte counts (lymphopenia)
- Low hemoglobin (anemia)
- Low platelet counts (thrombocytopenia)
- Cytokine release syndrome
- Infection
- Fatigue
- Musculoskeletal pain
- Hypogammaglobulinemia
- Diarrhea
- Upper respiratory infection
- Nausea
- Viral infections
- Encephalopathy
- Edema
- Pyrexia
- Cough
- Headache
- Decreased appetite
- Cytokine release syndrome
- Neurotoxicity
- Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
- Low blood counts
How are side effects of Abecma managed?
Approximately 30 to 60 minutes prior to Abecma infusion, patients receive acetaminophen and diphenhydramine. The use of dexamethasone or other systemic corticosteroids should be avoided. Patients will be monitored at least daily for 7 days following Abecma infusion for signs and symptoms of cytokine release syndrome and neurologic toxicities. Management guidelines will be followed if cytokine release syndrome or neurologic toxicity is suspected.
Clinical Studies
What have Abecma clinical trials shown?
The approval of Abecma was based on results from the KarMMa trial, a single-arm, multicenter trial to determine the efficacy of Abecma in patients with RRMM who had received at least three prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The trial enrolled 100 patients who received Abecma within the approved dose range of 300 to 460 × 106 CAR-positive T cells. The overall response rate was 72%, and 28% of patients achieved a stringent complete response (sCR). The median time to response was 30 days and median duration of response was 11 months. In patients who achieved sCR the median duration of response was 19 months.How is Abecma currently being studied in myeloma?
Abecma is being evaluated in several clinical trials in the U.S.- Phase 3 trial includes:
- Abecma vs standard treatment regimens for patients with RRMM (KarMMa-3 trial; NCT03651128)
- Phase 1 and 2 trials include:
- Abecma in patients with RRMM and in patients with high-risk MM (KarMMa-2 trial; NCT03601078)
- Abecma in patients with high-risk, newly diagnosed MM (KarMMa-4 trial; NCT04196491)
