CARVYKTI®
(ciltacabtagene autoleucel)
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CARVYKTI® (ciltacabtagene autoleucel)
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CARVYKTI - CARTITUDE-2 (MMY2003) Cohort A - Use in Progressive Multiple Myeloma After 1-3 Prior Lines of Therapy
Last Updated: 08/02/2024
SUMMARY
- Janssen does not recommend the use of CARVYKTI in a manner inconsistent with approved labeling.
- CARTITUDE-2 (MMY2003) is an ongoing, phase 2, multicohort, open-label study evaluating CARVYKTI in patients with multiple myeloma (MM) in various clinical settings. Cohort A is evaluating the efficacy and safety of CARVYKTI in patients who had progressive MM after 1-3 prior lines of therapy (LOT) and were refractory to lenalidomide.
1 - 5 - The Cohort A initial subgroup analysis evaluated 20 patients who received CARVYKTI that was manufactured with the clinical trial process. One patient was treated in an outpatient setting to evaluate the suitability of outpatient administration for CARVYKTI.1-4
- Efficacy outcomes are presented in Table:CARTITUDE-2 Cohort A Initial Subgroup: Efficacy - Response
.4 - At a median follow-up of 29.9 months (range, 3.3-35.6), a total of 17 patients had minimal residual disease (MRD)-evaluable samples at the 10-5
threshold; 100% of evaluable patients were MRD negative (primary endpoint).4 - The overall response rate (ORR) was 95% and 85% of patients achieved a stringent complete response (sCR).4
- At a median follow-up of 29.9 months (range, 3.3-35.6), a total of 17 patients had minimal residual disease (MRD)-evaluable samples at the 10-5
- The most common hematologic adverse events (AEs) of any grade occurring in ≥20% of patients at a median follow-up of 29.9 months are noted in Table: CARTITUDE-2 Cohort A Initial Subgroup: Hematologic Adverse Events (≥ 20% Any Grade).4
Secondary primary malignancy (SPM) was reported in 1 patient (grade 3 mucoepidermoid carcinoma; not treatment related).4 - The incidence, timing/duration and management of CRS are detailed in Table: CARTITUDE-2 Cohort A Initial Subgroup: CRS.2
-4 - The incidence of neurotoxicity is detailed in Table: CARTITUDE-2 Cohort A Initial Subgroup: Neurotoxicities.2-4,
6 No patient cases of movement and neurocognitive treatment-emergent adverse events (MNTs)/signs and symptoms of parkinsonism were reported for patients in the initial subgroup analysis of Cohort A.4 A total of 5 deaths have occurred after CARVYKTI infusion. The reasons for death were: COVID-19 pneumonia (n=1; treatment related; day 100), sepsis (n=1; not treatment related; day 394) and progressive disease (n=3; day 426, day 550 and day 666).4
- Efficacy outcomes are presented in Table:CARTITUDE-2 Cohort A Initial Subgroup: Efficacy - Response
- The Cohort A expansion subgroup analysis evaluated 23 patients who received CARVYKTI that was manufactured with a commercial process.5
- Efficacy outcomes are presented in Table: CARTITUDE-2 Cohort A Expansion Subgroup: Efficacy Outcomes.5
- At a median follow up of 15.6 months (range, 1.0-29.2), a total of 16 patients had minimal MRD-evaluable samples at the 10-5 threshold; 100% of evaluable patients were MRD-negative (primary endpoint).5
- Details regarding the incidence of treatment emergent (TEAEs) in the expansion subgroup including hematologic AEs, CRS and neurotoxicity are noted in Table: CARTITUDE-2 Cohort A Expansion Subgroup: Select TEAEs.5
- Efficacy outcomes are presented in Table: CARTITUDE-2 Cohort A Expansion Subgroup: Efficacy Outcomes.5
CLINICAL DATA - CARTITUDE-2 Cohort a initial subgroup analysis
The Cohort A initial subgroup analysis evaluated 20 patients who received CARVYKTI that was manufactured with the clinical trial process.1-4
Study Design/Methods
- The study design is presented in the Figure: CARTITUDE-2 (Cohort A) Study Design.
Abbreviations: BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; cilta-cel, ciltacabtagene autoleucel; Cy, cyclophosphamide; ECOG PS, Eastern Cooperative Oncology Group performance status; Flu, fludarabine; ICANS, immune effector cell-associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; MM, multiple myeloma; MRD, minimal residual disease; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NGF, next-generation flow; NGS, next-generation sequencing; ORR, overall response rate; PD, pharmacodynamics; PI, proteasome inhibitor; PK, pharmacokinetics.
a
- Per protocol, bone marrow aspirate samples for MRD evaluation were collected at time of suspected complete response (CR)/stringent complete response(sCR); for all dosed patients at months 2, 6, 12, 18, and 24 and yearly thereafter for patients in CR/sCR.4
Results
Patient Demographics and Disease/Treatment Characteristics
- Overall, 20 patients were lymphodepleted and treated with CARVYKTI in Cohort A of the CARTITUDE2 study. Patient details are presented in Table: CARTITUDE-2 Cohort A Initial Subgroup: Demographics and Disease Characteristics.1-4
- Median follow-up at data cut-off was 29.9 months (range, 3.3-35.6).4
- One patient was treated in an outpatient setting to evaluate the suitability of outpatient administration for CARVYKTI.2,3
| Total (N=20) | |
|---|---|
| Median age (range), years | 60 (38-75) |
| Male, n (%) | 13 (65.0) |
| Race, n (%) | |
| White | 18 (90.0) |
| Black/African American | 2 (10.0) |
| Asian | 0 |
| Not reported | 0 |
| Extramedullary plasmacytomas ≥1, n (%) | 3 (15.0) |
| Bone marrow plasma cellsa, ≥60%, n (%) | 3 (15.0) |
| High-risk cytogenetic profile, n (%) | 7 (35.0)b |
| del17p | 3 (15.0) |
| t(14;16) | 5 (25.0) |
| t(4;14) | 0 |
| 1q | 0 |
| Median years since diagnosis (range) | 3.5 (0.7-8.0) |
| Median prior lines of therapy, n (range) | 2 (1-3) |
| Prior stem-cell transplantation, n (%) | |
| Autologous | 17 (85.0) |
| Allogenic | 0 |
| Triple-class exposedc | 13 (65.0) |
| Penta-drug exposed d | 4 (20.0) |
| Refractory status, n (%) | |
| Carfilzomib | 2 (10) |
| Pomalidomide | 7 (35) |
| Bortezomib | 8 (40) |
| Daratumumab | 12 (60) |
| Triple-class refractoryc | 8 (40.0) |
| Penta-drug refractoryd | 1 (5.0) |
| Refractory to last line of therapy, n (%) | 19 (95.0) |
| aMaximum value from bone marrow biopsy and bone marrow aspirate is selected if both results are available.bOne patient had both del17p and t(14:16); 6 patients had unknown cytogenetics.cAt least 1 proteasome inhibitor, at least 1 immunomodulatory drug, and 1 anti-CD38 antibody. d≥2 proteasome inhibitors, ≥2 immunomodulatory drugs, and 1 anti-CD38 antibody. | |
Efficacy
- The initial subgroup analysis for Cohort A has been evaluated for response in 20 patients at a median follow-up of 5.8 months (range, 2.5-9.8), 14.3 months (range, 3.3-19.0 months), 17.1 months (range 3.3-23.1) and 29.9 months (range, 3.3-35.6) respectively. Efficacy outcomes are presented in Table: CARTITUDE-2 Cohort A Initial Subgroup: Efficacy - Response.1-4
- At a median follow-up of 29.9 months, ORR was 95%; a total of 85% of patients achieved a sCR and 90% of patients achieved ≥CR.4
- Overall, 17 patients had MRD-evaluable samples
at the 10-5 threshold; 100% of patients were MRD negative (primary endpoint).4 - A total of 11 patients had samples evaluable for sustained MRD-negativity at ≥6 months and 14 patients had samples evaluable for sustained MRD-negativity at ≥12-months. Sustained MRD-negativity at the 10-5 threshold for ≥6 months was reported in 8 patients (72.7%) and sustained MRD-negativity for ≥12 months was reported in 7 patients (50.0%).
4 - MRD-negative CR/sCR was achieved in 85.0% of patients (17/20).4
- A total of 11 patients had samples evaluable for sustained MRD-negativity at ≥6 months and 14 patients had samples evaluable for sustained MRD-negativity at ≥12-months. Sustained MRD-negativity at the 10-5 threshold for ≥6 months was reported in 8 patients (72.7%) and sustained MRD-negativity for ≥12 months was reported in 7 patients (50.0%).
- The PFS rates (95% CI) at 6 months, 12 months, 15 months, and 24 months were 95% (69.5-99.3), 84% (59.1-94.7), 70% (45.1-85.3) and 75% (50.0-88.7) respectively.1-4
- The 24-month OS rate was 75% (95% CI, 50.0-88.7).4
- The 24-month DOR rate was 73.3% (95% CI, 47.2-87.9).4
| Parameter | N=20 | |||
|---|---|---|---|---|
| Median Follow-Up | ||||
| 5.8 Months | 14.3 Months | 17.1 Months | 29.9 Months | |
| ORR, % (95% CI) | 95 (75-100) | 95 (75.1-99.9) | 95 (75.1-99.9) | 95 - |
| sCR, % (95% CI) | 45 | 75 | 85 (62.1-96.8) | 85 |
| CR, % | 30 | 10 | 5 | 5 |
| VGPR, % | 10 | 5 | 5 | 5 |
| PR, % | 10 | 5 | - | - |
| Evaluable patients for overall MRD negativitya, n | 4 | 13 | 16 | 17 |
| Overall MRD-negative at 10-5 sensitivity level, % (95% CI) | 100 | 92 (64.0-99.8) | 100 (79.4-100.0) | 100 |
| Median time to first response, months (range) | 1.0 (0.7-3.3) | 1.0 (0.7-3.3) | 1.0 (0.7-3.3) | 0.99 (0.7-3.3) |
| Median time to best response, months (range) | 1.9 (0.9-5.1) | 2.6 (0.9-7.9) | 2.6 (0.9-13.6) | 3.25 (0.9-13.6) |
| Median DOR, months (95% CI) | NR | NR | NRb | - |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; MRD, minimal residual disease; NE, not estimable; NGF, next-generation flow; NGS, next-generation sequencing; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.aPatients who were MRD evaluable had a clone identified and had at least one post-baseline MRD sample that included sufficient cells for evaluation at the 10-5 testing threshold (for NGS) or patients who had at least one post-baseline sample with the result of either positive or negative (for NGF).bEstimated 90% of responders remained in response for 12 months. | ||||
Safety
The most common (any grade) nonhematologic AEs occurring in ≥20% of patients at a median follow-up of 14.3 months are noted in Table: CARTITUDE-2 Cohort A Initial Subgroup: Nonhematologic Adverse Events (≥20% Any Grade).2 - At the 29.9-month median follow-up, TEAEs of any grade were reported in 100% of patients (n=20); serious TEAEs of any grade were reported in 50% of patients (n=10).4
- The most common (all grade) hematologic AEs occurring in ≥20% of patients at a median follow-up of 29.9 months are noted in Table: CARTITUDE-2 Cohort A Initial Subgroup: Hematologic Adverse Events (≥20% Any Grade).4
- Incidence of initial grade 3/4 hematologic events not recovered to grade ≤2 by day 60 was 20% for neutropenia, 15% for thrombocytopenia, and 5% for lymphopenia (reported at the 17.1-month median follow-up).3
- SPM was reported in 1 patient (grade 3 mucoepidermoid carcinoma; not treatment related).4
- A total of 5 deaths have occurred after CARVYKTI infusion. The reasons for death were as follows2-4:
- COVID-19 pneumonia (n=1; treatment related; day 100; patient also had an adverse event of sepsis in addition to COVID-19 pneumonia)
- Sepsis (n=1; not treatment related; day 394)
- Progressive disease (n=3; day 426, day 550 and day 666)
- One patient treated with CARVYKTI in an outpatient setting experienced grade 2 CRS 9 days after CARVYKTI infusion with a duration of 2 days and grade 2 isolated facial paralysis 29 days after infusion. The patient was treated with dexamethasone and the facial paralysis resolved completely within 51 days of onset.2
Cytokine Release Syndrome
- The incidence, timing/duration, and management of CRS are detailed in Table: CARTITUDE-2 Cohort A Initial Subgroup: CRS.2-4
- CRS of any grade occurred in 95% of patients (n=19) with grade 3/4 CRS occurring in 10% of patients (n=2). The median time to CRS onset was 7 days (range, 5-9) with a median duration of 3 days (range, 2-12). At the time of data cut-off, all CRS cases had resolved.4
Neurotoxicity
- The incidence of neurotoxicity is detailed in Table: CARTITUDE-2 Cohort A Initial Subgroup: Neurotoxicities.2-4,6
- Total CAR-T cell neurotoxicity of any grade occurred in 30% of patients (n=6) and grade 3/4 events occurred in 5% of patients (n=1).4
- ICANS of any grade occurred in 15% of patients (n=3). The median time to onset of ICANS was 8 days (range, 7-10)with a median duration of 3 days (range, 1-3). At the time of data cut-off, all ICANS cases had resolved.4
- Other neurotoxicities of any grade occurred in 3 patients (15%); 1 case each of peripheral sensorimotor neuropathy (recovering/resolving), anosmia (resolved), and facial paralysis (resolved). A grade 3/4 event occurred in 1 patient (5%). The median time to onset of other neurotoxicities was 30 days with a median duration of 80 days.4
- At a clinical cut-off date of April 12, 2023; grade 2 cranial nerve palsy (CNP) occurred in 1 patient (5%) which presented as facial nerve palsy, ie, involving cranial nerve VII. The CNP resolved in this patient.8
- No patient cases of MNTs/signs and symptoms of parkinsonism were reported for patients in Cohort A.4
- Since implementation, patient management strategies across the CARTITUDE program have reduced the incidence of MNTs/parkinsonism.2,3
- Preventative measures, monitoring and management strategies included enhanced bridging therapy to reduce tumor burden, early and aggressive supportive care including steroids for any grade ICANS and tocilizumab for any-grade ICANS with concurrent CRS, handwriting assessments using a novel handwriting tool for early detection of neurotoxicity symptoms, and extended monitoring beyond the first 100 days post-CARVYKTI infusion (up to 1 year).3,9
- Preventative measures, monitoring and management strategies included enhanced bridging therapy to reduce tumor burden, early and aggressive supportive care including steroids for any grade ICANS and tocilizumab for any-grade ICANS with concurrent CRS, handwriting assessments using a novel handwriting tool for early detection of neurotoxicity symptoms, and extended monitoring beyond the first 100 days post-CARVYKTI infusion (up to 1 year).3,9
| N=20 | ||
|---|---|---|
| Any Grade | Grade 3/4 | |
| Metabolism and nutrition disorders | ||
| Hypokalemia | 9 (45) | 0 |
| Hypocalcemia | 8 (40) | 3 (15) |
| Hypophosphatemia | 7 (35) | 4 (20) |
| Hypomagnesemia | 6 (30) | 0 |
| Decreased appetite | 5 (25) | 3 (15) |
| Gastrointestinal | ||
| Diarrhea | 8 (40) | 3 (15) |
| Nausea | 6 (30) | 0 |
| Constipation | 4 (20) | 0 |
| Vomiting | 4 (20) | 0 |
| Other | ||
| Fatigue | 8 (40) | 0 |
| Back pain | 6 (30) | 2 (10) |
| Gamma-glutamyl transferase increase | 4 (20) | 1 (5) |
| Weight decreased | 4 (20) | 1 (5) |
| Pyrexia | 4 (20) | 0 |
| Arthralgia | 4 (20) | 0 |
| Renal Impairment | 4 (20) | 0 |
| Abbreviations: AE, adverse event. aIncidence and severity of adverse events were assessed per Common Terminology criteria for AEs version 5.0.bMedian follow-up of 14.3 months. | ||
| Eventa , n (%) | N=20 | |
|---|---|---|
| Any Grade | Grade 3/4 | |
| Neutropenia | 19 (95.0) | 19 (95.0) |
| Lymphopenia | 16 (80.0) | 16 (80.0) |
| Thrombocytopenia | 16 (80.0) | 8 (40.0) |
| Anemia | 15 (75.0) | 9 (45.0) |
| Leukopenia | 12 (60.0) | 12 (60.0) |
| aMedian follow-up of 29.9 months. | ||
| Total (N=20) | |
|---|---|
| Patients with a CRS event (any grade)a, n (%) | 19 (95) |
| Patients with CRS (Grade 3/4)a, n (%) | 2 (10) |
| Median time to onset of CRS, days (range) | 7 (5-9) |
| Median duration of CRS, days (range) | 3 (2-12) |
| Supportive Measuresb, n (%) | |
| Tocilizumab | 14 (70) |
| IV fluids | 8 (40) |
| Corticosteroids | 6 (30) |
| Oxygen | 4 (20) |
| Anakinra | 1 (5) |
| Vasopressor | 1 (5) |
| Abbreviations: CRS, cytokine release syndrome; IV, intravenous. aCRS was graded according to the American Society for Transplantation and Cellular Therapy criteria.bIncludes supportive measures to treat CRS events and symptoms. | |
| Total (N=20) | ||
|---|---|---|
| Any Grade | Grade 3/4 | |
| Neurotoxicity, n (%) | 6 (30.0) | 1 (5.0) |
| ICANSa, n (%) | 3 (15.0) | 0 |
| Other neurotoxicitiesb, n (%) | 3(15.0)c | 1 (5.0) |
| MNT | 0 | 0 |
| Abbreviations: AE, adverse event; CRS, cytokine release syndrome; ICANS, Immune effector cell-associated neurotoxicity syndrome; MNT, movement and neurocognitive treatment-emergent adverse event. aICANS was graded according to the American Society for Transplantation and Cellular Therapy criteria.bEvents not reported as ICANS (ie, onset after a period of recovery from CRS and/or ICANS)c1 case each of peripheral sensorimotor neuropathy (recovering/resolving), anosmia (resolved), and facial paralysis (resolved). | ||
Pharmacokinetics
CAR+ T Cell Expansion, Persistence and Cytokines
- Peak expansion of CAR-T cells occurred on day 11 (range, 8.7–42.9); median persistence was 153 days (range, 57.1–336.8).3
- Levels of interleukin-6 (IL-6), interferon gamma (IFN-gamma), IL-2Rα, and IL-10 increased post infusion and peaked at days 7–14. Return to baseline levels occurred within 2–3 months post infusion.3
Cytokines and cluster of differentiation (CD4/CD8) ratio with respect to CRS and ICANS
CLINICAL DATA - CARTITUDE-2 cohort a expansion subgroup aNALYSIS
The CARTITUDE-2 Cohort A study evaluating the efficacy and safety of CARVYKTI in patients who had progressive MM after 1-3 prior LOT and were refractory to lenalidomide was expanded to assess CARVYKTI manufactured with a commercial process (expansion subgroup).5
The Cohort A expansion subgroup analysis evaluated 23 patients who received CARVYKTI that was manufactured with a commercial process.5
Study Design/Methods
- The study design is presented in the Figure: CARTITUDE-2 (Cohort A) Study Design.
Results
Patient Demographics and Disease/Treatment Characteristics
- A total of 24 patients were enrolled, and 23 patients were treated with CARVYKTI (22 patients at the target dose).5
- Median follow-up at data cut-off was 15.6 months (range, 1.0-29.2).5
- Patient details and a summary of baseline characteristics for the expansion subgroup are presented in Table: CARTITUDE-2 Cohort A Expansion Subgroup: Baseline Demographics and Disease Characteristics.5
| Characteristic | N=23 |
|---|---|
| Age, median (range), years | 63 (37-74) |
| Male, n (%) | 12 (52.2) |
| Race, n (%) | |
| White | 15 (65.2) |
| Black | 2 (8.7) |
| Asian | 1 (4.3) |
| American Indian or Alaska native | 1 (4.3) |
| Not reported | 4 (17.4) |
| ECOG score at screening, n (%) | |
| 0 | 15 (65.2) |
| 1 | 8 (34.8) |
| ISS Stage at baseline, n (%) | |
| I | 17 (73.9) |
| II | 2 (8.7) |
| III | 4 (17.4) |
| Bone marrow plasma cells, ≥60%, n (%)a | 3 (13.6) |
| Soft tissue plasmacytomas, n (%) | 4 (17.4) |
| High-risk cytogenetic at baselineb, n (%) | 4 (17.4) |
| del17p | 2 (8.7) |
| t(14;16) | 3 (13.0) |
| Years since diagnosis, median (range) | 3.9 (0.7-11.1) |
| Median prior LOT, median (range) | 3 (1-3) |
| Prior lot, n (%) | |
| 1 | 7 (30.4) |
| 2 | 4 (17.4) |
| 3 | 12 (52.2) |
| Previous ASCT | 19 (82.6) |
| Exposure status, n (%) | |
| Daratumumab | 14 (60.9) |
| Triple-classc | 14 (60.9) |
| Penta-drugd | 6 (26.1) |
| Refractory status, n (%) | |
| Triple-classc | 10 (43.5) |
| Penta-drugd | 3 (13.0) |
| Last LOT | 22 (95.7) |
| Abbreviations: ASCT, autologous stem cell transplant; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; LOT, line of therapy; PI, proteasome inhibitor.aMaximum value from bone marrow biopsy and bone marrow aspirate is selected if both the results are available (n=22).b1 patient had more than 1 high-risk cytogenetic feature and no patients had t(4;14).cIncludes 1 PI, 1 immunomodulatory drug, and 1 anti-CD38 monoclonal antibody.dIncludes ≥2 PIs, ≥2 immunomodulatory drugs, and 1 anti-CD38 monoclonal antibody. | |
Efficacy
- At a median follow-up of 15.6 months (range, 1.0-29.2), 23 patients were evaluated in the expansion subgroup population (22 patients at the target dose). Efficacy outcomes are presented in Table:
CARTITUDE-2 Cohort A Expansion Subgroup: Efficacy Outcomes.5 - MRD-negativity at the 10-5 threshold was achieved in 72.7% (16/22; 95% CI, 49.8-89.3) of patients.5
- Among 20 responders (defined as patients with a ≥PR), the median time to first response was 1.0 months (range, 0.9-9.8).5
- The overall response rate was 90.9% (20/22 of patients achieved a response).5
- The median PFS was NR (95% CI, 12.3-NE) and median OS (95% CI, 17.2-NE) were not reached.5
| Parameter | N=22 |
|---|---|
| 90.9 | |
| sCR | 63.6 |
| CR | 4.5 |
| VGPR | 4.5 |
| PR | 18.2 |
| ≥CR | 68.2 |
| MRD-negative CR/sCRa | 59.1 |
| Evaluable patients for overall MRD negativity, n (%; 95% CI) | 16 (72.7; 49.8-89.3) |
| Overall MRD-negative at 10-5 sensitivity level, % (95% CI) | 100 (79.4-100.0) |
| Median time to MRD negativity, years (range) | 1.9 (1.0-12.3) |
| Time to first response, median (range), monthsa | 1.0 (0.9-9.8) |
| Time to best response, median (range), monthsa | 6.2 (0.9-18.9) |
| DORa | |
| Median DOR (95% CI)a | NR (NE-NE) |
| 12-month DOR rate, % (95% CI)a | 78.8 (52.7-91.5) |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; MRD, minimal residual disease; NE, not estimable; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.aN=20, determined among patients with a ≥PR. | |
Safety
- Details regarding the incidence of TEAEs in the expansion subgroup are noted in Table: CARTITUDE-2 Cohort A Expansion Subgroup: Select TEAEs.5
- All patients had grade 3 or 4 hematologic TEAEs.5
- Secondary primary malignancies were reported in 2 patients, which were not considered treatment-related per investigator assessment.5
- Death was reported in 1 patient due to sepsis that was diagnosed on day 30 (treatment-related).5
Cytokine Release Syndrome
- CRS of any grade occurred in 100% of patients (n=23): no grade 3/4 CRS occurred. The median time to CRS onset was 8 days and recovery was 4 days.5
Neurotoxicity
- Total CAR-T cell neurotoxicity of any grade occurred in 17.4% of patients (n=4), with grade 3/4 events occurring in 4.3% of patients (n=1).5
- ICANS of any grade occurred in 17.4% of patients (n=4). Grade 3/4 ICANS occurred in 4.3% of patients (n=1).5
| Select TEAEs by maximum severity, n (%) | N=23 | |
|---|---|---|
| Any Grade | Grade 3 or 4 | |
| Any TEAEa | 23 (100.0) | 22 (95.7) |
| Hematologic | 23 (100.0) | 23 (100.0) |
| Neutropenia | 22 (95.7) | 22 (95.7) |
| Leukopenia | 15 (65.2) | 15 (65.2) |
| Lymphopenia | 15 (65.2) | 14 (60.9) |
| Anemia | 13 (56.5) | 9 (39.1) |
| Thrombocytopenia | 13 (56.5) | 9 (39.1) |
| Infections | 8 (34.8) | 1 (4.3) |
| AEs of special interest | ||
| CRS | 23 (100.0) | 0 |
| Neurotoxicity | 4 (17.4) | 1 (4.3) |
| ICANS | 4 (17.4) | 1 (4.3) |
| Other neurotoxicitiesb | 0 | 0 |
| MNTs/parkinsonism | 0 | 0 |
| Abbreviations: AE, adverse event; CAR-T, chimeric antigen receptor T-cell; CRS, cytokine release syndrome; ICANS, immune effector cell associated neurotoxicity syndrome; MNT, movement and neurocognitive treatment-emergent adverse event; TEAE, treatment-emergent adverse event. a1 patient had a maximum treatment emergent adverse event of grade 5 sepsis. bOther neurotoxicites were defined as neurological adverse events determined by the investigator to be related to CAR-T cell therapy and occurring after recovery of CRS and/or ICANS. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Agha M, Cohen A, Madduri D, et al. CARTITUDE-2: efficacy and safety of ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma after 1–3 prior lines of therapy. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021; Virtual. |
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