Single infusion of CARVYKTI delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma – J&J
Johnson & Johnson announced 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.
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.
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. The primary endpoint was minimal residual disease (MRD) negativity. Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI infusion without maintenance therapy.
At a median follow-up of 60.7 months:
i) Half of the patients (n=10, 50%) remained alive and progression-free at five years
ii) The five-year overall survival rate was 69.2%
iii) Median progression-free survival was 60.5 months
iv) 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. All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods.
Long-term remissions were observed even among patients with high-risk disease features. 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.
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. 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.
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.
