Backed by Strong Survival, Janssen Submits BLA for Multiple Myeloma Drug

Learn about the application of multiple myeloma drug.

Learn about the application of multiple myeloma drug.

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application (BLA) for its teclistamab to the U.S. Food and Drug Administration. The drug, which is being developed for relapsed or refractory (r/r) multiple myeloma, is an off-the-shelf, T-cell redirecting, bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3.

The BLA is built on data from the Phase I/II MajesTEC-1 clinical trial. Janssen presented data from the studies at the American Society of Hematology (ASH) 2021 Annual Meeting. At the median follow-up of about eight months, the overall response rate (ORR) was 62% at the recommended subcutaneous (SC) Phase II dose of 1.5 mg/kg in heavily pretreated patients who had at least three previous lines of therapy and were triple-class exposed. At the clinical cutoff date, median duration of response (DOR) was not hit and 88% of responders were alive and continuing treatment, suggesting response to the drug was durable and improved over time. In patients who responded, median time to first confirmed response was 1.2 months.

Results of Multiple Myeloma Drug

Of patients receiving teclistamab, 58% hit a very good partial response (VGPR) or better, and 29% achieved a complete response (CR) or better. Of them, 21% had a stringent complete response (sCR). Progression-free survival (PFS) rate at nine months was 59%.

“Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high,” said Dr. Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology at Janssen Research & Development. “Our relentless pursuit of treatments for this disease continues with the same sense of urgency that we have always had. We look forward to working with the FDA in their review of our teclistamab submission.”

The drug is being tested in several clinical trials by itself and in combination with other drugs. In 2020, the FDA and the European Commission granted the drug Orphan Drug Designation for multiple myeloma. In January 2021 it received PRIority MEdicines (PRIME) designation by the European Medicines Agency and in June 2021, the FDA granted it Breakthrough Therapy Designation.

“The deep expertise, creativity and persistence of the entire Janssen R&D organization enabled the expeditious advancement of teclistamab for multiple myeloma,” said Dr. Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development at Johnson & Johnson. “Today’s submission is another important step in our commitment to bring to patients truly transformational medicines that profoundly impact their health.”

Teclistamab isn’t the only weapon Janssen has in its arsenal against multiple myeloma. At the ASH meeting in mid-December, the company also presented longer-term results from the Phase Ib/II CARTITUDE-1 trial of ciltacabtagene autoleucel (cilta-cel) a BCMA-directed CAR T therapy. The data demonstrated deep and durable responses with an ORR of 98%.

Responses in 97 patients receiving the therapy grew over time, with 83% achieving stringent complete response (sCR) at the median 22-month follow-up. At this point, median PFS and median OS were not achieved, which supports the likelihood of long-term durability and survival.

“Unfortunately, patients with multiple myeloma for whom at least three treatment regimens have stopped working, face a median survival of less than a year with currently available treatments,” said principal study investigator Dr. Thomas Martin, M.D., director of clinical research, clinical professor of medicine, adult leukemia and bone marrow transplantation program, associate director, myeloma program and co-leader, hematopoietic malignancies program at UCSF Helen Diller Family Comprehensive Cancer Center. “The CARTITUDE-1 data presented at ASH 2021 builds upon previous results that show that a single infusion of cilta-cel resulted in durable responses and long-term survival across the study population, further confirming the potential of cilta-cel in offering patients and physicians a valuable new treatment option.”

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