Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

June 1, 2021 (RARITAN, N.J.) – 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).1 These data also showed 66 percent of patients were progression free and alive at 18 months (95 percent Confidence Interval [CI], range, 54.9–75.0). The latest findings to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, showed an overall survival (OS) of 81 percent (95 percent CI, range, 71.4–87.6)1 and response rates comparable across prespecified subgroups and lines of treatment (Abstract #8005).1 Data from the CARTITUDE-1 study supported the U.S. Food and Drug Administration Biologics License Application, which has recently been accepted for priority review. “The efficacy results observed in heavily pretreated patients with multiple myeloma receiving cilta-cel are remarkable,” said Saad Z. Usmani, M.D.†, Division Chief of Plasma Ce...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news