Johnson & Johnson has reported new long-term data showing that half of patients in early line relapsed or refractory multiple myeloma remained alive and progression-free for at least five years after a single infusion of Carvykti. Findings come from cohort A of the phase 2 CARTITUDE-2 study involving 20 patients.
The company said the results build on treatment-free remissions seen in CARTITUDE-1 and suggest that earlier use of cilta-cel may improve long-term disease control. Data were presented at the International Myeloma Society Annual Meeting.
“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, Professor of Hematology, University Medical Center, Amsterdam. “These new cilta-cel 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 cilta-cel may have curative potential for some patients and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey,” explained Yusri Elsayed, 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.”
“While outcomes for patients with multiple myeloma have improved significantly in recent years, unmet needs remain for patients with relapsed or refractory disease, when the disease can become harder to control and achieving sustained remission becomes more challenging,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “A single infusion of cilta-cel, a CAR-T cell therapy designed to harness a patient’s own immune system to target myeloma cells, has demonstrated the potential to deliver deep and durable responses.”
CARTITUDE-2 enrolled patients who had received one to three prior lines of therapy and were refractory to lenalidomide. At a median follow-up of 60.7 months, half remained progression-free, overall survival reached 69.2% and median progression-free survival was 60.5 months.
All three patients assessed for minimal residual disease at five years were negative at the deepest level tested. Long-term remissions were also seen in patients with high-risk cytogenetics.
Safety findings were consistent with the known profile of cilta-cel. One new haematologic malignancy and two deaths were reported during extended follow-up.
