Updated analysis showed Carvykti (ciltacabtagene autoleucel) improved survival for multiple myeloma patients regardless of their cytogenetic risk or prior lines of therapy.
Subgroup analysis of the Phase III CARTITUDE-4 trial (NCT04181827) showed Johnson & Johnson’s (J&J) Carvykti improved overall (OS) and progression-free survival (PFS) for relapsed or refractory multiple myeloma patients (r/r MM) compared to standard-of-care (SOC). The drugmaker presented their abstract on 1 June at the 2025 American Society of Clinical Oncology (ASCO) conference in Chicago, taking place from 30 May to 3 June.
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CARTITUDE-4 enrolled 419 patients internationally who had refractory MM following treatment with lenalidomide. Patients were randomised to receive Carvykti infusion with either PVd (pomalidomide, bortezomib, and demathesone) or DPv (daratumumab, pomalidomide, and dexamethasone) SOC treatment, or PVd/DPv SOC alone.
At a median follow-up of 33.6 months, median PFS among those with extramedullary disease, a risk factor associated with poor prognosis, was found to be 13 months for Carvytki-treated patients versus 4 months for those given SOC. Median OS was not reached for the Carykti subgroup, being 16 months for the SOC group.
This benefit was consistent regardless of prior treatment. For patients with one, two, or three lines of prior therapy (pLOT), median PFS was not reached for all groups with Carvykti while SOC patients achieved median PFS of 17, 12, and eight months, respectively. Median OS was also not reached for all groups treated with Carvykti or those SOC patients with one or two pLOT but was 34 months for SOC patients with 3 prior lines.
Carvykti first gained approval from the US Food and Drug Administration (FDA) to treat r/r MM in March 2022 based on results from the Phase Ib/II CARTITUDE-1 trial. It has since further proven its efficacy in this indication, including as part of presentations from prior years’ ASCO conferences. The drug has since been approved by the FDA as a second-line MM therapy in April 2024.
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By GlobalDataAs per a June 2023 publication, primary data from CARTITUDE-4 showed that at 12 months, PFS was 75.9% with Carvykti and 48.6% without; minimal residual disease (MRD) was absent among 60.6% of patients on Carvykti, just 15.6% for those given SOC. GlobalData projects the drug will generate total global sales of $1.7bn in 2025, a figure estimated to rise to $7.2bn by 2031.
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