
Nikhil Munshi, MD, on Final Data on Cilta-Cel in Multiple Myeloma From CARTITUDE-1
Therapy Status
Carvykti (ciltacabtagene autoleucel)
Johnson & Johnson / Legend Biotech
Approved for relapsed/refractory multiple myeloma after at least 1 prior line of therapy (lenalidomide-refractory). Boxed warnings cover CRS, ICANS, Parkinsonism/GBS, HLH/MAS, prolonged cytopenias, immune effector cell-associated enterocolitis (added October 2025), and secondary hematologic malignancies. The CAR-T REMS program was eliminated in June 2025.
- October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest
The associate professor from Dana Farber Cancer Center and Harvard Medical School discussed continued efficacy and safety data presented at the 2023 EHA Meeting.
“The take home message is that CAR T-cells are extremely effective. The toxicity is manageable and so, its utilization in our patients, even in elderly patients, should become an important component of therapeutic management... I do see CAR T-cell probably aspart of a combined immunotherapy approach CAR T-cells and bispecificimmunomodulators are going to become standard of treatment, and most likely curative treatment in myeloma.”
A final analysis of the phase 1b/2 CARTITUDE-1 trial (NCT03548207) of the approved chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel (cilta-cel; Carvykti; Janssen) in patients with relapsed/refractory multiple myeloma was presented at
CGTLive™’s sister site, OncLive™, spoke with Munshi while at EHA to learn more about the updated data and the continued efficacy seen with cilta-cel since its 2022 approval. He also went over the study population and the favorable safety profile observed. Munshi shared his thoughts about the future outlook with CAR T-cell therapy and multiple myeloma, including bringing up the use of CAR T-cell therapy into earlier lines of treatment and combining modes of treatment such as bispecific antibodies with CAR T-cell therapy.
REFERENCE
Munshi N, Martin T, Usmani SZ, et al. CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Presented at: EHA 2023 Congress. Abstract S202
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