On September 25, 2026 Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, reported new long-term follow-up data from the initial subgroup of cohort A in the Phase 2 CARTITUDE-2 study (N=20) showing that 50% of patients (10/20) in early line relapsed or refractory multiple myeloma (RRMM) who were treated with a single infusion of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free for at least five years without maintenance therapy.1 These results build on the durable, treatment-free remissions observed in the CARTITUDE-1 study, which evaluated patients in later lines of therapy, and reinforce that earlier treatment with CARVYKTI may increase long-term remission and disease control. Together, these findings add to the emerging evidence suggesting that CARVYKTI may have curative potential in some patients.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Findings were presented at the International Myeloma Society (IMS) Annual Meeting (Abstract #PA-288).
Expert and company perspectives on earlier treatment-free remissions with CARVYKTI
"Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma," said Niels van de Donk, M.D., Ph.D., Professor of Hematology, University Medical Center, Amsterdam, the Netherlands.* "These new CARVYKTI findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance."
"These results add to the growing body of evidence suggesting that CARVYKTI may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment."
Phase 2 CARTITUDE-2 study build on previous findings
CARTITUDE-2 cohort A (N=20) enrolled patients with RRMM who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.1 The primary endpoint was minimal residual disease (MRD) negativity.1 Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI infusion without maintenance therapy.1
At a median follow-up of 60.7 months:
Half of the patients (n=10, 50%) remained alive and progression-free at five years
The five-year overall survival rate was 69.2%
Median progression-free survival was 60.5 months
Patients received a single CARVYKTI infusion without maintenance therapy
At five years, MRD was assessed by bone marrow in three patients and was not required per protocol.1 All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods.1
Long-term remissions were observed even among patients with high-risk disease features.1 Of the 10 patients who remained alive and progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features.1
The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI, with no new CAR T-cell-related neurotoxicity reported.1 Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer.1
About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing, multicohort Phase 2 study evaluating the efficacy and safety of ciltacabtagene autoleucel (CARVYKTI) in patients in different clinical settings, including patients with one to three prior lines of therapy, and continues to generate long-term follow-up data on depth and durability of response. CARTITUDE-2 findings have been presented at major medical congresses, including the International Myeloma Society (IMS) Annual Meeting, and contribute to the growing body of evidence supporting earlier use of CARVYKTI in multiple myeloma.
About multiple myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.1 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.2 Multiple myeloma is the third most common blood cancer worldwide.3 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.4 People living with multiple myeloma have a 5-year survival rate of 59.8%.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.6,7 In recent years, potential overall survival has improved from years to decades for some patients, with effective treatment options now available across every stage and line of therapy.
(Press release, Johnson & Johnson, SEP 25, 2026, View Source [SID1234671086])