MajesTEC-9 Clinical Trial of Teclistamab in Patients With Multiple Myeloma

Описание: Roberto Mina, MD, Associate Professor at Winship Cancer Institute of Emory University, discusses the Majestec-9 clinical trial of Tecvayli (teclistamab) in patients with multiple myeloma (MM).

MM is a form of cancer due to abnormal and uncontrolled growth of plasma cells in the bone marrow. The most common symptom is anemia, which can be associated with fatigue and shortness of breath. Other features of the condition may include multiple infections, abnormal bleeding, bone pain, weak and/or easily broken bones, and numbness and/or weakness of the arms and legs. The exact underlying cause of MM is currently unknown. While there are many therapies approved for this indication, a significant unmet need for additional, well–tolerated therapies remains, especially in earlier lines of therapy for patients refractory to anti–CD38 monoclonal antibodies and lenalidomide, commonly used medications in multiple myeloma.

Teclistamab is a bispecific T-cell engager antibody therapy designed to activate the immune system by binding to the CD3 receptor and B-cell maturation antigen. Teclistamab received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf antibody administered as a subcutaneous treatment for adult patients with relapsed or refractory MM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Recently, data was published on positive topline results from the investigational phase 3 MajesTEC-9 (NCT05572515) clinical trial evaluating the safety and efficacy of teclistamab monotherapy in patients predominantly refractory to anti-CD38 and lenalidomide therapies. Of the total number of patients enrolled, 85% were refractory to anti-CD38 monoclonal antibodies, 79% were refractory to lenalidomide, and over 90% were refractory to their last line of therapy.

Among those randomized to teclistamab, a clinically meaningful and statistically significant reduction of 71% was observed in risk of progression or death and a 40% reduction was observed in risk of death. The safety profile was consistent with its known profile and no new safety signals were identified.

The full results of the study will be presented at a future major medical meeting and shared with global health authorities. Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.

Chapters:
Introduction 00:00
Need for More Effective Therapeutics 00:15
MajesTEC-9 Clinical Trial 2:51
Standard of Care Within Trial 6:05
Take Home Message 6:37