JNJ 4528 showed early, deep and durable responses in heavily pretreated patients with multiple myeloma.Janssen Pharmaceutical Companies.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/II CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ 4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. Longer-term follow-up results from the Phase 1b portion of the study (n=29), to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #8505), show that all patients responded to treatment and that the responses were deep and durable with 86 percent of patients achieving stringent complete response at a median follow-up of 11.5 months and 86 percent of patients being alive and progression free at 9 months.

The 100 percent overall response rate (ORR) included 97 percent of patients achieving a very good partial response or better and three percent achieving a partial response. Responses were observed among heavily pretreated patients (n=29) at a low dose of CAR-T cells (median administered dose 0.72×106 CAR+ viable T cells/kg). Patients evaluated had received a median of five (range, 3-18) prior treatment regimens; 86 percent were triple-refractory and 28 percent were penta-refractory. The median time to first response was one month (range, 1-3), and 81 percent of evaluable patients (n=16) achieved minimal residual disease (MRD)-negative disease status at 10-5 or 10-6 at the time of first suspected complete response.

“The longer-term results for JNJ 4528, as demonstrated through the latest findings from the CARTITUDE-1 study, show the continued treatment effect for heavily pretreated patients who faced a dismal prognosis,” said Jesus G Berdeja, M.D., Director of Myeloma Research, Sarah Cannon Research Institute, and principal study investigator. “We’re encouraged by not only the relatively high rate of stringent complete responses, but also the progression-free survival seen in these patients.”.