CARTITUDE-1

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlighting a deepening response over time (increasing from 67 percent presented at ASH 2020).

CARTITUDE-2

Findings from Cohort A (n=20) in the Phase 2 CARTITUDE-2 (NCT04133636) study evaluating the safety and efficacy of cilta-cel in patients with multiple myeloma whose disease progressed after one to three prior lines of therapy, and who were lenalidomide refractory, will be presented for the first time at ASCO (Abstract #8013) and as an oral presentation at the European Hematology Association (EHA) Congress (Abstract #S190). Results from this cohort showed early and deep responses at a median of 5.8 months of follow-up2, and an ORR of 95 percent with 45 percent of patients achieving a sCR, 30 percent of patients achieving a CR, 10 percent of patients achieving a VGPR, and 10 percent of patients achieving a PR.2 The overall safety profile, including incidence of CRS and most common hematologic AEs, was consistent with observations in the CARTITUDE clinical development program.