Janssen shares positive phase 3 results for cilta-cel in multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of Carvykti (ciltacabtagene autoleucel; cilta-cel) in certain patients with multiple myeloma.

Multiple myeloma is a blood cancer that affects plasma cells – a type of white blood cell – inside the bone marrow.

The American Cancer Society estimates that over 35,000 new cases will be diagnosed in the US this year, with over 12,000 deaths expected as a result of the disease.

The phase 3 CARTITUDE-4 study compared the immunotherapy to standard care treatment regimes in adults with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy.

The results, which were presented at the American Society of Clinical Oncology annual meeting, showed that at 16 months median follow-up, a single infusion of cilta-cel reduced the risk of disease progression or death by 74% compared to standard care.

Significant improvements were also seen across progression-free survival and response rates in the cilta-cel cohort, the company said, and no new safety signals were observed.

Positive results from a final analysis of the phase 1b/2 CARTITUDE-1 study, which evaluated cilta-cel in adults with relapsed and refractory (R/R) multiple myeloma who had received three or more prior lines of therapy, were also presented at ASCO.

Cilta-cel has already been granted conditional marketing authorisation in the EU to treat adults with R/R multiple myeloma who have received at least three prior therapies, and has been approved in the US for these patients who have received four or more prior lines of therapy.

Janssen also submitted an application to the European Medicines Agency last month, based on the results from CARTITUDE-4, seeking approval of cilta-cel for the earlier treatment of patients with relapsed and lenalidomide-refractory multiple myeloma.

Edmond Chan, senior director, EMEA therapeutic area lead haematology, Janssen-Cilag, said: "The latest CARTITUDE-1 and CARTITUDE-4 data reinforces the potential of a single infusion of cilta-cel, both in the heavily pretreated R/R patient population for which it is currently approved, and in eligible patients as early as after first relapse.

“Our goal has always been to address the needs of patients at each stage of the disease, and ultimately achieve sustained remissions earlier in their treatment journey, and we are excited to be making great progress towards this ambition with cilta-cel.”

Janssen entered into a worldwide licence and collaboration agreement with Legend Biotech in 2017 to develop and commercialise cilta-cel.