Janssen Pharmaceuticals has reported preliminary results from the first-in-human phase I dose escalation study of teclistamab for patients with relapsed or refractory multiple myeloma. Teclistamab is an investigational bispecific antibody targeting both B-cell maturation antigen and CD3 receptors on T-cells. The treatment achieved a 67% overall response rate among 12 patients who received the highest dosage, with 3 of the patients achieving a complete response. The full results of the clinical trial will be reported at the ASCO20 Virtual Scientific Program.
The study enrolled adult patients with multiple myeloma who had received a median of six prior lines of treatment, had previously been treated with a proteasome inhibitor and an immunomodulatory drug, and had relapsed or were refractory to established therapies. Patients were treated with teclistamab at varying doses, ranging from 0.3-270 µg/kg. Of the 78 patients who were administered teclistamab, 21 responded to the treatment. Responses were found to be deep and persistent and, at the time of data cutoff, 16 of the 21 patients had an ongoing response.
The most common adverse events occurring in >20% of patients were anemia, cytokine release syndrome, neutropenia, thrombocytopenia, and pyrexia. One death occurred, which the team concluded was not related to treatment.
Researchers are currently working on a dosage expansion study to test the highest range of teclistamab that can be safely administered.
Sources: Janssen Pharmaceuticals press release, May 18, 2020; ClinicalTrials.Gov, May 20, 2020; Endpoints News, May 18, 2020.