by Dr. C.H. Weaver M.D. 6/2021
Results from an ongoing Phase 1 dose escalation clinical trial of teclistamab (JNJ-64007957) for the treatment of relapsed or refractory multiple myeloma appear encouraging and were featured during the American Society of Hematology (ASH) 2020 Annual Meeting with follow up data at ASCO 2021 in June. In November 2020, the U.S. Food and Drug Administration (FDA) granted teclistamab orphan drug status.
About Multiple Myeloma
Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells are an important part of the immune system; they produce antibodies to help fight infection and disease. Multiple myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses. Because patients whose cancer has returned following prior therapy are typically considered incurable, treatment is aimed at extending survival as well as maintaining quality of life.
Teclistamab is a bispecific antibody administered subcutaneously that targets both BCMA and CD3. BCMA, (B-cell maturation antigen), is expressed at high levels on multiple myeloma cells and teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to kill the targeted cells.
The current trial enrolled patients with multiple myeloma who had relapsed or were refractory to established myeloma therapies and had previously been treated with a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD). Enrolled patients had received a median of six prior lines of treatment (range, 2-14).
In total, 157 patients were enrolled in the trial. Teclistamab appeared well tolerated. The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. CRS occurred at a median onset of 2 days (range, 1-6) and lasted for a median of 2 days (range, 1-8).
The overall response rate was 65% and more than 40% experienced a complete response or better. The median duration of response has not been reached and 26 of the responders, 22 (85%) survive after a median follow-up of 7.1 months (range, 3.0-12.2).
Teclistamab appears to be an effective new precision cancer medicine for the treatment of Multiple Myeloma. Enrollment in the clinical trial will continue and updated safety and effectiveness results will be forthcoming.
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- Garfall, AL et al. Updated Phase 1 Results of Teclistamab, a B-cell Maturation Antigen (BCMA) × CD3 Bispecific Antibody, in Relapsed and/or Refractory Multiple Myeloma (RRMM). 2020 American Society of Hematology Annual Meeting. December 2020.
- American Cancer Society. "Key Statistics About Multiple Myeloma." Available here. Accessed January 2020.
- Krishnan AY, Garfall AL, Mateos MV, et al. Updated phase 1 results of teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM). J Clin Oncol. 2021;39:(suppl 15; abstr 8007). doi:10.1200/JCO.2021.39.15_suppl.8007.