CARVYKTI delivers five year treatment free remission in half of early line relapsed multiple myeloma patients

Johnson & Johnson has reported five year follow up data from the Phase II CARTITUDE 2 study showing durable treatment free remissions with a single infusion of CARVYKTI, also known as ciltacabtagene autoleucel, in patients with early line relapsed or refractory multiple myeloma.

The analysis focused on the initial subgroup of cohort A, which included 20 patients who had previously received between one and three lines of therapy.

At a median follow up of 60.7 months, 50% of patients remained alive and progression free for at least five years without receiving maintenance treatment.

The five year overall survival rate was 69.2%, while median progression free survival reached 60.5 months.

Patients in cohort A had previously been exposed to a proteasome inhibitor and were refractory to lenalidomide.

The primary endpoint of CARTITUDE 2 was minimal residual disease negativity, with the long term follow up assessing outcomes after a single CARVYKTI infusion without maintenance therapy.

At the five year point, bone marrow testing for minimal residual disease was performed in three patients, although this assessment was not required under the study protocol.

All three patients were MRD negative at the deepest level tested, at 10 to the power of minus six, meaning no disease was detected using highly sensitive testing methods.

Long term remission was also seen among patients with high risk disease characteristics.

Of the 10 patients who remained alive and progression free at five years, five had at least one high risk cytogenetic abnormality.

Four of those patients had two or more high risk features.

Niels van de Donk, MD, PhD, Professor of Hematology at University Medical Center Amsterdam, said treatment free remissions lasting this long were difficult to imagine for many patients with relapsed or refractory multiple myeloma several years ago.

He said the findings provide further evidence that using highly effective therapies earlier in the disease course could give more patients the opportunity to achieve deep and durable remissions without ongoing maintenance treatment.

Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head of Oncology at Johnson & Johnson, said the findings add to evidence suggesting CARVYKTI may have curative potential for some patients.

He said the results also support the strategy of introducing highly effective treatments earlier in the multiple myeloma treatment pathway.

The findings build on results from the CARTITUDE 1 study, which evaluated CARVYKTI in patients who had received more previous lines of therapy.

Johnson & Johnson said the combined evidence suggests that earlier use of CARVYKTI could increase the likelihood of long term disease control and prolonged treatment free remission.

The safety profile observed with longer follow up remained consistent with the established profile of CARVYKTI.

No new CAR T cell related neurotoxicity was reported.

Since the previous analysis, one patient developed a new haematological malignancy, acute myeloid leukaemia.

Two additional deaths were reported, one associated with progressive disease and another with a new cancer.

The latest CARTITUDE 2 findings were presented at the International Myeloma Society Annual Meeting.

---

---

Related Topics and Keywords

cancer research, CART cell therapy, carvykti, cell therapy, clinical trials, haemotology, Johnson and Johnson, MRD, multiple myeloma, Oncology, pharma news, RRMM