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CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma

June 4, 2024 – Biotechnology, Clinical Trials, Drug Discovery – Janssen, Johnson & Johnson Innovative Medicine, multiple myeloma

73% reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy

3 June 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company announced today results from a subgroup analysis of the phase 3 CARTITUDE-4 study. The data shows CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival (PFS), compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), for patients with lenalidomide-refractory multiple myeloma after one prior line of therapy (LOT), including patients with functional high-risk (FHR) multiple myeloma. FHR was defined as progressive disease within 18 months after receiving autologous stem cell transplant (ASCT), or the start of initial frontline therapy in patients with no ASCT. This data was featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 31 May-4 June (Abstract #7504) and will also be shared at the 2024 European Hematology Association (EHA) Congress, taking place in Madrid from 13-16 June (Abstract #P959).

Data from the CARTITUDE-4 study supported the recent European Commission (EC) approval of cilta-cel, the first B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with relapsed and refractory multiple myeloma, as early as after first relapse.

A phase 3 CARTITUDE-4 subgroup analysis included 136 patients (cilta-cel, n=68; standard therapies, n=68) who received one prior LOT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and were lenalidomide-refractory. After a median follow-up of 16 months (range, 0.1-27), median PFS was not reached (NR) (95% Confidence Interval [CI]; not estimable [NE]-NE) among patients who received cilta-cel, compared to 17 months (95% CI, 11-NE) for the control arm as a second-line treatment (hazard ratio [HR]=0.35 [95% CI, 0.2-0.7; p=0.0007]).

In an additional subgroup analysis of 79 patients with FHR multiple myeloma (cilta-cel, n=40; standard therapies: n=39), median PFS was NR (18-NE) with cilta-cel versus 12 months (8-NE) with standard therapies (HR=0.27 [95% CI, 0.1-0.6; p=0.0006]). Patients treated with cilta-cel had deeper overall response rates (88%; 80%), complete response (CR) or better (68%; 39%), minimal residual disease (MRD) negativity (65%; 10%), and longer median duration of response (mDOR) (NR [16-NE]; 16 [8-NE]) compared to those treated with standard therapies.

“Patients with functional high-risk myeloma whose disease progressed during the first 18 months of initial myeloma therapy are known to have poor prognosis, yet they have not been well represented in any clinical trial,” said Luciano J Costa MD PhD, professor of Medicine and Director of the Multiple Myeloma Program, University of Alabama at Birmingham, US, and principal study investigator. “This subset analysis of CARTITUDE-4 provides strong evidence that these patients greatly benefit from cilta-cel and will help healthcare professionals better understand the potential of this therapy.”

The proportion of patients with grade 3 or higher treatment emergent adverse events (TEAEs) was comparable among patients who received cilta-cel versus standard therapies as second-line treatment (96%, 96%) and those with one prior LOT and FHR multiple myeloma (100%, 97%), respectively. Overall, 11 patients in the cilta-cel one prior LOT subgroup and 11 patients in the standard therapies one prior LOT subgroup died. Of patients with FHR multiple myeloma, seven patients from the cilta-cel arm and nine who received standard therapies died. Of the seven deaths in patients with one prior LOT and FHR multiple myeloma, two did not receive cilta-cel as study treatment and three received cilta-cel as subsequent therapy.

“Many patients with FHR multiple myeloma from the CARTITUDE-4 subgroup analysis experienced deep and durable responses following the single infusion of cilta-cel, further supporting the potential to treat a broader patient population,” said Jordan Schecter MD, vice president, Disease Area Leader, Multiple Myeloma, at Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, we aspire to eliminate cancer and remain steadfast in our commitment to realising the full potential of cilta-cel to improve outcomes for patients.”

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.janssen.com/emea.