Carvykti infusion improves minimal residual disease in myeloma

MRD is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma. These results add to the overall survival (OS) benefits recently presented at the International Myeloma Society meeting earlier this year, as the first and only cell therapy to significantly extend OS versus standard therapies for patients with multiple myeloma. Findings were featured in an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (Abstract #1032).

“Carvykti  has established its significant impact on overall survival and improved progression-free survival compared to standard therapies,” said Rakesh Popat, M.D., University College London Hospitals, NHS Foundation Trust, London, UK, and lead study investigator.* “The MRD negativity results demonstrate deep responses compared to standard therapies for people living with multiple myeloma and further underscore the benefit of Carvykti  administered as a single infusion as early as second line.”

The Phase III CARTITUDE-4 study evaluated Carvykti  compared to standard therapies of PVd or DPd for the treatment of patients with RRMM as early as after one prior line of therapy. Patients who received one to three prior lines of therapy, including a PI and immunomodulatory agent (IMiD), and were lenalidomide-refractory, were randomized (Carvykti, n=208, standard therapies, n=211). At a median follow-up of almost three years (34 months), MRD-negativity rates for evaluable patients were more than double in those treated with Carvykti versus standard therapies (89 percent, 38 percent; P<0.0001). At 2.5 years, sustained (12 months or more), MRD-negative complete response or better in evaluable patients treated with Carvykti was five-fold higher than that of standard therapies (52 percent, 10 percent; P<0.0001). A post-hoc comparison between CARTITUDE-4 and CARTITUDE-1 was also presented, comparing earlier treatment (1-3 versus 3+ prior lines of therapy) demonstrating higher rates of MRD negativity, progression-free survival (PFS) and OS rates when Carvykti is used earlier in treatment.

“We are thrilled to present the latest MRD negativity results from the CARTITUDE-4 study showing that Carvykti, the first and only cell therapy approved for the treatment of patients with multiple myeloma as early as second line, shows profound long-term remission rates, including progression-free survival and overall survival benefits,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “It is also increasingly clear that reaching MRD negativity is a key goal with CAR-T therapy in myeloma, and we see that MRD rates were higher in this analysis with earlier treatment.”

Additional data on patient reported outcomes (PROs) and time to worsening (TTW) of symptoms with Carvykti  will also be presented at ASH 2024 as a poster presentation (Abstract #2002). Based on the Multiple Myeloma Symptom and Impact Questionnaire (MySlm-Q) system and impact domain scores, patients treated with Carvykti reported significantly longer TTW of symptoms compared to standard therapies. At three-year follow up, 83 percent of patients treated with Carvykti had not experienced worsening of functional impacts, compared to 69 percent in the standard therapies arm.

About CARTITUDE-4; CARTITUDE-4 (NCT04181827) is the first randomized Phase III study evaluating the efficacy and safety of Carvykti. The study compares Carvykti with standard of care treatments PVd or DPd in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The primary endpoint of the study is PFS; safety, OS, MRD negativity rate and overall response rate are secondary endpoints.