ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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Data at primary analysis. Safety profile remained consistent with longer follow-up and no new safety signals were observed.
Any Grade, % | Grade 3 or Higher, % | |
---|---|---|
150-450 × 106
CAR-positive T cells (N=127) |
150-450 × 106
CAR-positive T cells (N=127) |
|
Blood and lymphatic system disorders | ||
Febrile neutropenia | 16 | 16 |
Cardiac disorders | ||
Tachycardiaa | 19 | 0 |
Gastrointestinal disorders | ||
Diarrhea | 35 | 1.6 |
Nausea | 29 | 0 |
Constipation | 16 | 0 |
Vomiting | 15 | 0 |
Oral painb | 12 | 0 |
General disorders and administration site conditions | ||
Fatiguec | 45 | 3.1 |
Pyrexia | 25 | 1.6 |
General physical health deterioration | 11 | 10 |
Edemad | 25 | 0 |
Chills | 11 | 0 |
Immune system disorders | ||
Cytokine release syndrome | 85 | 9 |
Hypogammaglobulinemiae | 41 | 0.8 |
Infections and infestationsf | ||
Infections – Pathogen unspecified | 51 | 15 |
Viral infections | 27 | 9 |
Bacterial infections | 15 | 3.9 |
Pneumoniag | 17 | 9 |
Upper respiratory tract infectionh | 34 | 1.6 |
Investigations | ||
Weight decreased | 13 | 1.6 |
Metabolism and nutrition disorders | ||
Decreased appetitei | 22 | 0.8 |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal painj | 45 | 3.1 |
Motor dysfunctionk | 11 | 0 |
Nervous system disorders | ||
Encephalopathyl | 26 | 6 |
Headachem | 23 | 0 |
Dizzinessn | 17 | 0.8 |
Neuropathy peripheralo | 17 | 0.8 |
Tremorp | 10 | 0 |
Psychiatric disorders | ||
Insomniaq | 13 | 0 |
Anxietyr | 12 | 0.8 |
Renal and urinary disorders | ||
Renal failures | 10 | 2.4 |
Respiratory, thoracic, and mediastinal disorders | ||
Cought | 23 | 0 |
Dyspneau | 13 | 2.4 |
Skin and subcutaneous tissue disorders | ||
Rashv | 14 | 0.8 |
Xerosisw | 11 | 0 |
Vascular disorders | ||
Hypotensionx | 17 | 0 |
Hypertension | 11 | 3.1 |
View all
Blood and lymphatic system disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) | 150-450 × 106 (N=127) |
Febrile neutropenia | |
16 | 16 |
Cardiac disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Tachycardiaa | |
19 | 0 |
Gastrointestinal disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Diarrhea | |
35 | 1.6 |
Nausea | |
29 | 0 |
Constipation | |
16 | 0 |
Vomiting | |
15 | 0 |
Oral painb | |
12 | 0 |
General disorders and administration site conditions
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Fatiguec | |
45 | 3.1 |
Pyrexia | |
25 | 1.6 |
General physical health deterioration | |
11 | 10 |
Edemad | |
25 | 0 |
Chills | |
11 | 0 |
Immune system disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Cytokine release syndrome | |
85 | 9 |
Hypogammaglobulinemiae | |
41 | 0.8 |
Infections and infestationsf
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Infections — Pathogen unspecifiedf | |
51 | 15 |
Viral infections | |
27 | 9 |
Bacterial infections | |
15 | 3.9 |
Pneumoniag | |
17 | 9 |
Upper respiratory tract infectionh | |
34 | 1.6 |
Investigations
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Weight decreased | |
13 | 1.6 |
Metabolism and nutrition disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Decreased appetitei | |
22 | 0.8 |
Musculoskeletal and connective tissue disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Musculoskeletal painj | |
45 | 3.1 |
Motor dysfunctionk | |
11 | 0 |
Nervous system disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Encephalopathyl | |
26 | 6 |
Headachem | |
23 | 0 |
Dizzinessn | |
17 | 0.8 |
Neuropathy peripheralo | |
17 | 0.8 |
Tremorp | |
10 | 0 |
Psychiatric disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Insomniaq | |
13 | 0 |
Anxietyr | |
12 | 0.8 |
Renal and urinary disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Renal failures | |
10 | 2.4 |
Respiratory, thoracic, and mediastinal disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Cought | |
23 | 0 |
Dyspneau | |
13 | 2.4 |
Skin and subcutaneous tissue disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Rashv | |
14 | 0.8 |
Xerosisw | |
11 | 0 |
Vascular disorders
Any Grade, % | Grade 3 or Higher, % |
---|---|
150-450 × 106 (N=127) |
150-450 × 106 (N=127) |
Hypotensionx | |
17 | 0 |
Hypertension | |
11 | 3.1 |
aTachycardia includes sinus tachycardia, tachycardia.
bOral pain includes oral pain, oropharyngeal pain, toothache.
cFatigue includes asthenia, fatigue, malaise.
dEdema includes edema, face edema, fluid overload, fluid retention, generalized edema, peripheral edema, peripheral swelling, scrotal swelling, swelling.
eHypogammaglobulinemia includes patients with adverse events (21%) of blood immunoglobulin G decreased, hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 500 mg/dL following ABECMA infusion (25%).
fInfections and infestations System Organ Class Adverse Events are grouped by pathogen type and selected clinical syndromes.
gPneumonia includes bronchopulmonary aspergillosis, lung infection, pneumonia, pneumonia aspiration, pneumonia cytomegaloviral, pneumonia pneumococcal, pneumonia pseudomonal. Pneumonias may also be included under pathogen categories.
hUpper respiratory tract infection includes laryngitis, nasopharyngitis, pharyngeal erythema, pharyngitis, respiratory tract congestion, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract infection, upper respiratory tract infection bacterial. Upper respiratory tract infections may also be included under pathogen categories.
iDecreased appetite includes decreased appetite, hypophagia.
jMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, spinal pain.
kMotor dysfunction includes dysphonia, eyelid ptosis, hypotonia, motor dysfunction, muscle spasms, muscular weakness, restless legs syndrome.
lEncephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dyscalculia, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence, toxic encephalopathy.
mHeadache includes headache, head discomfort, sinus headache.
nDizziness includes dizziness, presyncope, syncope, vertigo.
oNeuropathy peripheral includes carpal tunnel syndrome, hypoesthesia, hypoesthesia oral, neuralgia, neuropathy peripheral, paresthesia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, sciatica.
pTremor includes asterixis, tremor.
qInsomnia includes insomnia, sleep deficit, sleep disorder.
rAnxiety includes anxiety, feeling jittery, nervousness.
sRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal impairment.
tCough includes cough, productive cough, upper-airway cough syndrome.
uDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.
vRash includes acne, dermatitis, dermatitis bullous, erythema, rash, rash macular, rash papular, urticaria.
wXerosis includes dry eye, dry mouth, dry skin, lip dry, xerosis.
xHypotension includes hypotension, orthostatic hypotension.
150-450 × 106
CAR-positive T cells (N=127) % |
|
---|---|
Neutropenia | 96 |
Leukopenia | 96 |
Lymphopenia | 92 |
Thrombocytopenia | 63 |
Anemia | 63 |
Hypophosphatemia | 45 |
Hyponatremia | 10 |
aPTT increased (seconds) | 10 |
Laboratory tests were graded according to NCI CTCAE Version 4.03. Laboratory abnormalities are sorted by decreasing frequency in the 150 to 450 × 106 column.
Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags.
aPTT=activated partial thromboplastin time; ARs=adverse reactions; CRS=cytokine release syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events