TECVAYLI® demonstrates lasting deep responses in relapsed/refractory multiple myeloma patients

Johnson & Johnson has announced extended data from its pivotal Phase 1/2 MajesTEC-1 study of TECVAYLI® (teclistamab-cqyv), showing promising results for patients with relapsed or refractory multiple myeloma (RRMM). These findings were featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The study highlighted that TECVAYLI® exhibited deep and durable responses in patients who had been exposed to triple-class treatments and had undergone three or more previous lines of therapy. Notably, the median duration of response was 24 months. Moreover, patients who transitioned to a biweekly dosing schedule also showed sustained benefits.

Separate analyses from the MajesTEC-1 and OPTec studies are pioneering steps towards outpatient administration of TECVAYLI®. The data indicated that the treatment could be administered with Tocilizumab prophylaxis to reduce the incidence of cytokine release syndrome (CRS), thus promoting an outpatient approach. This could significantly enhance the convenience and accessibility of the treatment for patients.

Niels van de Donk, M.D., a Professor of Hematology at Amsterdam University Medical Centers and the principal investigator of the study, emphasized the potential of teclistamab to transform the multiple myeloma treatment paradigm. He noted that the prolonged follow-up data from the MajesTEC-1 study demonstrate that teclistamab continues to provide deep and durable responses for patients with limited treatment options.

At a median follow-up of 30.4 months, the overall response rate (ORR) for patients treated with TECVAYLI® at the recommended Phase 2 dose was 63%, with 46% achieving a complete response or better. For these patients, median durations of response (mDOR), progression-free survival (mPFS), and overall survival (mOS) had not yet been reached, with estimated 30-month rates of 61%, 61%, and 74%, respectively. Patients who responded well to the treatment were allowed to switch to a biweekly dosing regimen, and 37 out of 38 maintained their responses.

The safety profile of TECVAYLI® remained consistent, with a noted decrease in the occurrence of severe infections over time. Common adverse events included neutropenia, anemia, thrombocytopenia, lymphopenia, and various infections. Notably, a significant reduction in new onset grade 3 or higher infections was observed, which may be attributed to the biweekly dosing schedule or other factors like the use of intravenous immunoglobulin.

Rachel Kobos, M.D., Vice President of Oncology Research & Development at Johnson & Johnson Innovative Medicine, praised TECVAYLI® for aiding over 10,000 patients over the past two years. She emphasized the company's commitment to addressing unmet needs in multiple myeloma treatment and continuing to develop new treatment options.

Further data from the MajesTEC-1 study, including a subgroup analysis of high-risk multiple myeloma patients, will be presented at the European Hematology Association (EHA) Congress. Initial results from the Phase 3 MajesTEC-7 study, which combines TECVAYLI® with daratumumab and lenalidomide for newly diagnosed, transplant-ineligible patients, also showed promising clinical profiles.

TECVAYLI® has received approval from the U.S. FDA and the European Commission for the treatment of adult patients with RRMM who have exhausted other treatment options. It is a first-in-class bispecific T-cell engager antibody therapy, designed to bind to CD3 receptors on T-cells and B-cell maturation antigen (BCMA) on multiple myeloma cells, thereby activating the immune system to target and destroy cancer cells.

The ongoing studies and extended follow-up data underscore the potential of TECVAYLI® to significantly improve the management and outcomes of patients with multiple myeloma, particularly in the outpatient setting.