CARVYKTI®
(ciltacabtagene autoleucel)
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CARVYKTI® (ciltacabtagene autoleucel)
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CARVYKTI - Prior Lines of Therapy in CARTITUDE-1 and CARTITUDE-4
Last Updated: 05/14/2024
Summary
- CARTITUDE-1 (MMY2001) was a phase 1b/2, open-label, single-arm, multicenter study that evaluated CARVYKTI in patients with relapsed/refractory multiple myeloma (RRMM) who had previously received a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-cluster of differentiation 38 (CD38) antibody. The combined analysis from the phase 1b/2 portions of the CARTITUDE-1 study evaluated the safety and efficacy of CARVYKTI in 97 patients with RRMM.1
- 3 - Patients received a median of 6 (range, 3-18) prior lines of therapy (LOT); 88% of patients were triple-class refractory, 42% of patients were penta-drug refractory and 99% of patients were refractory to the last LOT.2
After a median follow-up of 21.7 months and 27.7 months, responses were observed in most patients in high-risk subgroups (overall response rate [ORR] range, 95.1%-100%) including patients with 3 or ≥4 prior LOT and patients who were tripleclass or penta-drug refractory. 2, 4 - The incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and other chimeric antigen receptor-T (CAR-T) cell neurotoxicities (events not reported as ICANS) in the subgroups was consistent with the overall population.4
- Patients received a median of 6 (range, 3-18) prior lines of therapy (LOT); 88% of patients were triple-class refractory, 42% of patients were penta-drug refractory and 99% of patients were refractory to the last LOT.2
- CARTITUDE-4
(MMY3002) is a phase 3, randomized, open-label study evaluating the efficacy and safety of CARVYKTI vs standard care (physician’s choice of pomalidomide, bortezomib, and dexamethasone [PVd] or DARZALEX FASPRO® [daratumumab and hyaluronidase], pomalidomide, and dexamethasone [DPd]) in adult patients with lenalidomide-refractory multiple myeloma (MM) after 1-3 prior LOT.5 ,6 - Patients received a median of 2 (range, 1-3) prior LOT in both the CARVYKTI and standard care arms.7
- Progression-free survival (PFS) was analyzed in subgroups of patients with high-risk disease features in both the intent-to-treat (ITT) population and the as-treated population in the CARTITUDE-4 study.5,8
Select details of the analyses related to treatment history are provided in Table: CARTITUDE-4: PFS Analysis in Select Subgroups Related to Treatment History (ITT Population) and in Table: CARTITUDE-4: PFS Analysis in Select Subgroups Related to Treatment History (As-treated Population).
- Patients received a median of 2 (range, 1-3) prior LOT in both the CARVYKTI and standard care arms.7
Study Design/Methods
- The study design is presented in Figure: CARTITUDE-1 Study Design.
Abbreviations: CAR, chimeric antigen receptor; CD38, cluster of differentiation 38; cilta-cel, ciltacabtagene autoleucel; CR, complete response; Cy, cyclophosphamide; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; Flu, fludarabine; IMWG, International Myeloma Working Group; MM, multiple myeloma; MRD, minimal residual disease; ORR, overall response rate; OS, overall survival; PD, pharmacodynamics; PFS, progression-free survival; PI, proteasome inhibitor; PK, pharmacokinetics; RP2D, recommended phase 2 dose; sCR, stringent complete response; VGPR, very good partial response.
a
b
Results
- Overall, of the 113 patients enrolled/apheresed, 101 patients were lymphodepleted, and 97 patients were treated with CARVYKTI in the combined phase 1b/2 study.1-3 Patient details are presented in Table: CARTITUDE-1: Select Demographics and Disease Characteristics.
- Patients received a median of 6 prior LOT (range 3-18); 88% of patients were tripleclass refractory, 42% of patients were penta-class refractory, and 99% of patients were refractory to the last LOT.2-4
| Characteristics | Total (N=97) |
|---|---|
| Median age, years (range) | 61.0 (56-68) |
| Male, n (%) | 57 (59) |
| Black/African American, n (%) | 17 (18) |
| Plasmacytomasa, n (%) | 19 (19.6) |
| Extramedullary plasmacytomas, n (%) | 13 (13) |
| Bone-based plasmacytomas, n (%) | 6 (6.2) |
| Bone marrow plasma cells ≥60%, n (%) | 21 (22) |
| Median years since diagnosis, range | 5.9 (1.6-18.2) |
| High-risk cytogenetic profile, n (%) | 23 (24) |
| del17p | 19 (20) |
| t(14;16) | 2 (2) |
| t(4;14) | 3 (3) |
| Tumor BCMA expression ≥50%b, n (%) | 57 (92) |
| Median prior LOT, n (range) | 6 (3-18) |
| Prior LOT, n (%) | |
| 3 | 17 (17.5) |
| 4 | 16 (16.5) |
| ≥5 | 64 (66.0) |
| Received bridging therapy, n (%) | 73 (75) |
| Prior stem-cell transplantation, n (%) | |
| Autologous | 87 (90) |
| Allogenic | 8 (8) |
| Previous PIs | |
| Carfilzomib, n (%) | |
| Exposed | 83 (86) |
| Refractory | 63 (65) |
| Bortezomib, n (%) | |
| Exposed | 92 (95) |
| Refractory | 66 (68) |
| Ixazomib, n (%) | |
| Exposed | 29 (30) |
| Refractory | 27 (28) |
| Previous immunomodulatory agents | |
| Lenalidomide, n (%) | |
| Exposed | 96 (99) |
| Refractory | 79 (81) |
| Pomalidomide, n (%) | |
| Exposed | 89 (92) |
| Refractory | 81 (84) |
| Previous anti-CD38 monoclonal antibody | |
| Daratumumab, n (%) | |
| Exposed | 94 (97) |
| Refractory | 94 (97)c |
| Triple-class exposedd | 97 (100) |
| Triple-class refractoryd, n (%) | 85 (88) |
| Penta-drug exposede | 81 (84) |
| Penta-drug refractorye, n (%) | 41 (42) |
| Refractory to last LOT, n (%) | 96 (99) |
| Abbreviations: BCMA, B-cell maturation antigen; CD38, cluster of differentiation 38; del, deletion; LOT, line of therapy; PI, proteasome inhibitor; t, translocation. aAll plasmacytomas include extramedullary and bone-based plasmacytomas. bDenominator n=62, the number of evaluable samples; BCMA expression was detected in all evaluable samples. cAdditionally, 2 more patients were refractory to other anti-CD38 antibodies. dAt least 1 PI, 1 immunomodulatory agent, and 1 anti-CD38 antibody. e≥2 PIs, ≥2 immunomodulatory agents, and 1 anti-CD38 antibody. | |
Efficacy
- Efficacy outcomes in key subgroups of patients are presented in Table: CARTITUDE 1: Efficacy Outcomes in Key Subgroups at a Median Follow-Up of 27.7 Months.
- After a median follow-up of 21.7 months and 27.7 months, responses were observed in most patients in high-risk subgroups (ORR range, 95.1%-100%) including patients with 3 or ≥4 prior LOT and patients who were tripleclass or penta-drug refractory.2,4
| Overall | 3 Prior LOT | ≥4 Prior LOT | Triple-Class Refractory | Penta-Drug Refractory | |
|---|---|---|---|---|---|
| Patients, n (%) | 97 (100) | 17 (18) | 80 (82) | 85 (88) | 41 (42) |
| ORR, % (95% CI) | 97.9 (92.7-99.7) | 100.0 (80.5-100) | 97.5 (91.3-99.7) | 97.6 (91.8-99.7) | 95.1 (83.5-99.4) |
| Median DOR, months (95% CI) | NE (23.3-NE) | NE (12.9-NE) | 28.3 (23.3-NE) | NE (24.3-NE) | NE (24.4-NE) |
| MRD 10-5 | 56/61 (91.8) | 8 (80.0) | 48 (94.1) | 50 (92.6) | 17 (85.0) |
| Median PFS, (95% CI) | NE (24.5-NE) | NE (13.8-NE) | 30.1 (24.5-NE) | NE (25.2-NE) | NE (25.3-NE) |
| 27-month PFS, % (95% CI) | 54.9 (44.0-64.6) | 56.7 (30.0-76.6) | 54.0 (41.7-64.8) | 55.6 (43.8-65.9) | 61.6 (44.0-75.1) |
| 27-month OS, % (95% CI) | 70.4 (60.1-78.6) | 76.5 (48.8-90.4) | 69.0 (57.3-78.1) | 69.7 (58.4-78.5) | 66.8 (49.3-79.4) |
| Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; LOT, line of therapy; MRD, minimal residual disease; NE, not estimable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; sCR, stringent complete response. aIn MRD-evaluable patients, MRD was assessed in evaluable samples at a 10-5 threshold by next-generation sequencing (clonoSEQ®) in all treated patients at day 28, and at 6, 12, 18, and 24 months regardless of the status of disease measured in blood or urine. Only MRD assessments (10-5 testing threshold) within 3 months of achieving CR/sCR until death/progression/subsequent therapy (exclusive) are considered. | |||||
Safety
- The incidence of CRS, ICANS, and other CAR-T cell neurotoxicities (events not reported as ICANS) in subgroups was consistent with the overall population.4
CLINICAL DATA - CARTITUDE-4 - PHASE 3 STUDY
Study Design/Methods
- The study design is shown in Figure: CARTITUDE-4 Study Design.
aRandomization was stratified by choice of PVd vs DPd, ISS stage at screening (I vs II vs III), and number of prior LOT (1 vs 2-3).
bTreatment with PVd or DPd was continued until disease progression, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurred earlier.
cSecondary outcomes were sequentially tested at each prespecified significance level, including (in order) rates of CR or better, OR, MRD negativity, OS, and time to patient-reported symptom worsening as assessed by the MM Symptom and Impact Questionnaire.
Results
Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics
- Overall, 419 patients were randomized to receive CARVYKTI (n=208) or standard care (n=211; DPd [n=183] or PVd [n=28]).5
- All 208 patients randomized to the CARVYKTI arm received bridging therapy with either DPd (n=182) or PVd (n=26). A total of 176 patients (84.6%) received CARVYKTI as study treatment (as-treated population). In the as-treated population, 21.6% of patients received 1 bridging therapy cycle, 58.5% of patients received 2 bridging therapy cycles, and 19.9% of patients received 3-6 bridging therapy cycles.5,6
- Prior to receipt of CARVYKTI, 32 patients discontinued study treatment, mainly due to disease progression (n=30) or death (n=2) during bridging therapy or lymphodepletion. Of these, 20 patients received subsequent therapy with CARVYKTI. No patients discontinued treatment due to a manufacturing failure. The median time from apheresis material receipt to product release was 44 days (range, 25-127), and the median time from first apheresis to CARVYKTI infusion was 79 days (range, 45-246).5,12
- Prior to receipt of CARVYKTI, 32 patients discontinued study treatment, mainly due to disease progression (n=30) or death (n=2) during bridging therapy or lymphodepletion. Of these, 20 patients received subsequent therapy with CARVYKTI. No patients discontinued treatment due to a manufacturing failure. The median time from apheresis material receipt to product release was 44 days (range, 25-127), and the median time from first apheresis to CARVYKTI infusion was 79 days (range, 45-246).5,12
- A total of 208 patients (98.6%) were dosed with standard care.5
- Treatment discontinuation was reported in 131 standard care patients (63.0%), mostly due to disease progression (56.3%).5
- At data cutoff, 143 CARVYKTI patients were ongoing in the post-treatment phase and 77 patients were ongoing on standard care therapy.5
- All 208 patients randomized to the CARVYKTI arm received bridging therapy with either DPd (n=182) or PVd (n=26). A total of 176 patients (84.6%) received CARVYKTI as study treatment (as-treated population). In the as-treated population, 21.6% of patients received 1 bridging therapy cycle, 58.5% of patients received 2 bridging therapy cycles, and 19.9% of patients received 3-6 bridging therapy cycles.5,6
Patient details and a summary of prior therapies for the ITT population are presented in Table: CARTITUDE-4: Select Demographics and Disease Characteristics (ITT Population). - The median number of prior LOT in both the CARVYKTI and standard care arms was 2 (range, 1-3).7
- Patient details and a summary of prior therapies for the as-treated population are presented in Table: CARTITUDE-4: PFS Analysis in Select Subgroups Related to Treatment History (As-treated Population).
| CARVYKTI (n=208) | Standard Care (n=211) | |
|---|---|---|
| Age, median (range), years | 61.5 (27-78) | 61.0 (35-80) |
| Male, n (%) | 116 (55.8) | 124 (58.8) |
| Race, n (%) | ||
| White | 157 (75.5) | 157 (74.4) |
| Blacka | 6 (2.9) | 7 (3.3) |
| Asian | 16 (7.7) | 20 (9.5) |
| ECOG PS, n (%) | ||
| 0 | 114 (54.8) | 121 (57.3) |
| 1 | 93 (44.7) | 89 (42.2) |
| 2b | 1 (0.5) | 1 (0.5) |
| I | 136 (65.4) | 132 (62.6) |
| II | 60 (28.8) | 65 (30.8) |
| III | 12 (5.8) | 14 (6.6) |
| Median years since diagnosis, (range) | 3.0 (0.3-18.1) | 3.4 (0.4-22.1) |
| Presence of soft tissue plasmacytomasc, n (%) | 44 (21.2) | 35 (16.6) |
| Bone marrow plasma cells ≥60%d, n (%) | 42 (20.4) | 43 (20.7) |
| Cytogenetic riske, n (%) | ||
| Standard risk | 69 (33.3) | 70 (33.3) |
| High-risk | 123 (59.4) | 132 (62.9) |
| gain/amp(1q) | 89 (43.0) | 107 (51.0) |
| del (17p) | 49 (23.7) | 43 (20.5) |
| t(4;14) | 30 (14.5) | 30 (14.3) |
| t(14;16) | 3 (1.4) | 7 (3.3) |
| ≥2 high-risk abnormalities | 43 (20.8) | 49 (23.3) |
| del(17p), t(4;14), or t(14;16) | 73 (35.3) | 69 (32.9) |
| Unknown | 15 (7.2) | 8 (3.8) |
| Tumor BCMA expression ≥50%, n (%) | 141 (67.8) | 138 (65.4) |
| Prior LOT, n (%) | ||
| 1 | 68 (32.7) | 68 (32.2) |
| 2 | 83 (39.9) | 87 (41.2) |
| 3 | 57 (27.4) | 56 (26.5) |
| Prior immunomodulatory drugs, n (%) | 208 (100.0) | 211 (100.0) |
| Lenalidomide | 208 (100.0) | 211 (100.0) |
| Pomalidomide | 8 (3.8) | 10 (4.7) |
| Prior anti-CD38 antibody, n (%) | 53 (25.5) | 55 (26.1) |
| Daratumumab | 51 (24.5) | 54 (25.6) |
| Isatuximab | 2 (1.0) | 2 (0.9) |
| Prior PIs, n (%) | 208 (100.0) | 211 (100.0) |
| Bortezomib | 203 (97.6) | 205 (97.2) |
| Carfilzomib | 77 (37.0) | 66 (31.3) |
| Ixazomib | 21 (10.1) | 21 (10.0) |
| Triple-class exposedf | 53 (25.5) | 55 (26.1) |
| Penta-drug exposedg | 14 (6.7) | 10 (4.7) |
| Refractory status, n (%) | ||
| Lenalidomide | 208 (100.0) | 211 (100.0) |
| Bortezomib | 55 (26.4) | 48 (22.7) |
| Carfilzomib | 51 (24.5) | 45 (21.3) |
| Any anti-CD38 antibody | 50 (24.0) | 46 (21.8) |
| Daratumumab | 48 (23.1) | 45 (21.3) |
| Ixazomib | 15 (7.2) | 17 (8.1) |
| Pomalidomide | 8 (3.8) | 9 (4.3) |
| Triple-class refractoryf | 30 (14.4) | 33 (15.6) |
| Penta-drug refractoryg | 2 (1.0) | 1 (0.5) |
| Abbreviations: amp, amplification; BCMA, B-cell maturation antigen; CD38, cluster of differentiation 38; del, deletion; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, aAmong patients enrolled in the United States, 9 patients (14.1%) were Black. bLatest non-missing ECOG PS on or prior to apheresis/cycle 1 day 1 was used. All patients met the inclusion criteria of ECOG PS of 0 or 1 prior to randomization. cIncluding extramedullary and bone‑based plasmacytomas with a measurable soft tissue component. dIn 206 (CARVYKTI arm) and 208 (standard care arm) patients, the maximum value from the bone marrow biopsy and bone marrow aspirate results was selected if both results were available. eIn 207 (CARVYKTI arm) and 210 (standard care arm) patients. fIncluding 1 PI, 1 immunomodulatory drug, and 1 anti-CD38 antibody. gIncluding ≥2 PIs, ≥2 immunomodulatory drugs, and 1 anti-CD38 antibody. | ||
| Characteristic | As-treated Population (n=176) |
|---|---|
| Median age, years (range) | 61 (27-78) |
| Male, n (%) | 101 (57.4) |
| Race, n (%) | |
| White | 136 (77.3) |
| Black or African American | 6 (3.4) |
| Asian | 15 (8.5) |
| Not reported | 19 (10.8) |
| ECOG PS, n (%) | |
| 0 | 103 (58.5) |
| 1 | 73 (41.5) |
| ISS stage, n (%) | |
| I | 121 (68.8) |
| II | 45 (25.6) |
| III | 10 (5.7) |
| Bone marrow plasma cells ≥60%a, n (%) | 33 (18.9) |
| Presence of soft tissue plasmacytomasb, n (%) | |
| Yes | 30 (17.0) |
| No | 146 (83.0) |
| Cytogenetic riskc, n % | |
| Standard risk | 59 (33.7) |
| High riskd | 105 (60.0) |
| gain/amp(1q) | 77 (44.0) |
| del (17p) | 39 (22.3) |
| t(4;14) | 23 (13.1) |
| t(14;16) | 3 (1.7) |
| del(17p), t(14;16), or t(4;14) | 59 (33.7) |
| ≥2 high-risk abnormalities | 34 (19.4) |
| Unknown risk | 11 (6.3) |
| Number of prior LOT, n % | |
| 1 | 60 (34.1) |
| 2 | 66 (37.5) |
| 3 | 50 (28.4) |
| Treatment refractoriness, n (%) | |
| Triple-class refractorye | 20 (11.4) |
| Not triple-class refractory | 156 (88.6) |
| Treatment history, n (%) | |
| Prior daratumumab exposed | 36 (20.5) |
| Prior triple-class exposede | 37 (21.0) |
| Abbreviations: amp, amplification; CD38, cluster of differentiation 38; del, deletion; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, international staging system; LOT, line of therapy; PI, proteasome inhibitor; t, translocation. aThe maximum value from bone marrow biopsy and bone marrow aspirate results was selected if both results were available. bSoft tissue plasmacytomas included extramedullary and bone-based plasmacytomas with a measurable soft tissue component. cCytogenetic data for the as-treated population were available for 175 of 176 patients. dAny of the following features: del(17p), t(14;16), t(4;14), or gain/amp(1q). eIncluding 1 PI, 1 immunomodulatory drug, and 1 anti-CD38 monoclonal antibody. | |
Efficacy
PFS was analyzed in subgroups of patients with high-risk disease features in both the ITT and as-treated populations in the CARTITUDE-4 study.5,8
ITT Population
- At a median follow-up of 15.9 months (range, 0.1-27.3), CARVYKTI (n=208) demonstrated improved PFS vs standard care (n=211) in all analyzed subgroups in the ITT population. PFS in this population based on treatment history is presented in Table: CARTITUDE-4: PFS Analysis in Select Subgroups Related to Treatment History (ITT Population).8
As-treated Population
- At a median follow-up of 16.0 months after randomization (range, 3.8-27.3), 12-month PFS rate in the as-treated population (n=176) remained >82% in the presence of common markers of poor prognosis including triple-class refractoriness. Twelve-month PFS rates for these select patient groups are presented in Table:
CARTITUDE-4: PFS Analysis in Select Subgroups Related to Treatment History (As-treated Population).8 - Data in patients with prior daratumumab or triple-class exposure showed CARVYKTI was effective in this population.8
| Characteristic | Median PFS, Months (95% CI) | Hazard Ratioa (95% CI) | |
|---|---|---|---|
| CARVYKTI (n=208) | SOC (n=211) | ||
| Number of prior LOT | |||
| 1 | NR (NE-NE) | 17.4 (11.1-NE) | 0.35 (0.19-0.66) |
| 2 or 3 | NR (19.2-NE) | 10.2 (6.2-12.2) | 0.24 (0.16-0.37) |
| Refractory to | |||
| PI + immunomodulatory drug | 22.8 (18.0-NE) | 7.8 (4.7-11.5) | 0.24 (0.14-0.38) |
| Anti-CD38 + immunomodulatory drug | 18.0 (9.3-22.8) | 4.3 (3.4-5.7) | 0.26 (0.14-0.50) |
| Triple-classb | 19.3 (2.6-NE) | 4.1 (3.1-7.8) | 0.15 (0.05-0.39) |
| Neither anti-CD38 nor PI | NR (NE-NE) | 17.41 (12.0-22.4) | 0.20 (0.10-0.39) |
| Last line of prior therapy | NR (22.8-NE) | 11.8 (9.7-14.0) | 0.27 (0.19-0.39) |
| Prior exposure to | |||
| Daratumumab | 19.2 (9.7-NE) | 4.5 (3.6-7.5) | 0.23 (0.12-0.44) |
| Bortezomib | NR (22.8-NE) | 11.9 (9.8-14.0) | 0.27 (0.19-0.39) |
| Triple-classb | 19.2 (9.7-NE) | 4.7 (3.6-7.5) | 0.26 (0.14-0.48) |
| Bridging therapy/SOC | |||
| PVd | 11.7 (2.1-NE) | 5.0 (3.4-10.5) | 0.31 (0.13-0.72) |
| DPd | NR (22.8-NE) | 12.5 (10.3-16.0) | 0.26 (0.18-0.39) |
| Abbreviations: CD38, cluster of differentiation 38; CI, confidence interval; DPd, daratumumab, pomalidomide, and dexamethasone; ITT, intent-to-treat; LOT, line of therapy; NE, not estimable; NR, not reached; PFS, progression-free survival; PI, proteasome inhibitor; PVd, pomalidomide, bortezomib, and dexamethasone; SOC, standard of care. aHazard ratio and 95% CI from a Cox proportional hazards model with treatment as the sole explanatory variable, including only PFS events that occurred >8 weeks after randomization. A hazard ratio <1 indicates an advantage for the CARVYKTI arm. bPI + immunomodulatory drug + anti-CD38 antibody. | |||
| Characteristic | CARVYKTI (n=176) 12-Month PFS, % (95% CI) |
| Refractoriness | |
| Not triple-class refractory | 89.7 (83.7-93.5) |
| Triple-class refractorya | 90.0 (65.6-97.4) |
| Treatment history | |
| All patients | 84.9 (78.2-89.7) |
| Daratumumab exposed | 82.8 (65.7-91.9) |
| Triple-class exposeda | 83.3 (66.5-92.1) |
| Abbreviations: CD38, cluster of differentiation 38; CI, confidence interval; PFS, progression-free survival; PI, proteasome inhibitor. aPI + immunomodulatory drug + anti-CD38 antibody. | |
Safety
Safety outcomes in select subgroups related to treatment history in both the ITT and as-treated population in the CARTITUDE-4 study has not yet been presented.5,8
LITERATURE SEARCH
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 9 April 2024.
References
| 1 | Martin T, Usmani SZ, Berdeja JG, et al. Updated results from CARTITUDE-1: phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in patients with relapsed/refractory multiple myeloma. Oral presentation presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual. |
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