Janssen Announces FDA Breakthrough Therapy Designation for Teclistamab and Updated Clinical Data for Cilta-cel in Relapsed/Refractory Multiple Myeloma

Today, Janssen, a Johnson & Johnson company, announced that the U.S. FDA has granted Breakthrough Therapy Designation to teclistamab, a T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM). This marks the 11th Breakthrough Therapy Designation awarded to Janssen in oncology. The designation will help accelerate the development and regulatory review process for this innovative therapy. Earlier this year, teclistamab also received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA).

Teclistamab is a ready-to-use, subcutaneous bispecific antibody targeting BCMA and the CD3 receptor on T lymphocytes. The Breakthrough Therapy designation and priority drug designation were granted based on data from the Phase 1 clinical trial MajesTEC-1. In this dose-escalation clinical trial, with a median follow-up of over 6 months, patients with relapsed or refractory multiple myeloma (R/R MM) who received the Phase 2 recommended subcutaneous dose achieved an overall response rate (ORR) of 65%. These patients had a median of 5 prior lines of therapy.

The results demonstrated that patient responses were durable and deepened over time. Fifty-eight percent of patients achieved a very good partial response (VGPR), and 40% achieved a complete response. At a median follow-up of 7.1 months, 85% of responding patients remained on treatment. Updated results from this study will be presented at the upcoming ASCO Annual Meeting.

Meanwhile, Janssen also announced the latest clinical trial results for ciltacabtagene autoleucel (cilta-cel), a BCMA-targeted CAR-T therapy co-developed with Legend Biotech. This CAR-T therapy was recently granted Priority Review designation by the U.S. FDA.

The latest results are from the Phase 1b/2 CARTITUDE-1 clinical trial. Results announced today by Janssen Pharmaceuticals show that at a median follow-up of 18 months, the ORR reached 98%, with 80% of patients achieving a stringent complete response (sCR). This sCR rate represents a further increase compared to the 67% reported at last year’s ASH Annual Meeting (median follow-up: 12.4 months). These data demonstrate that responses continue to deepen over time in patients who achieve a response.

The data also showed that at 18 months, 66% of patients were progression-free, with an overall survival rate of 81%.

Note: The original text has been abridged.

References:

[1] Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma. Retrieved June 1, 2021, from https://www.janssen.com/janssen-announces-us-fda-breakthrough-therapy-designation-granted-teclistamab-treatment-relapsed-or

[2] Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma. Retrieved June 1, 2021, from https://www.janssen.com/janssen-reports-new-data-bcma-car-t-cilta-cel-showing-deep-and-durable-responses-patients-relapsed

[3] Janssen's Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma. Retrieved June 1, 2021, from https://www.janssen.com/janssens-updated-phase-1-results-teclistamab-suggest-deep-durable-responses-patients-heavily

[4] Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs. Retrieved June 1, 2021, from https://www.janssen.com/janssen-highlights-commitment-advancing-transformative-innovations-oncology-scientific-updates-deep

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