Janssen Reports Positive New Teclistamab Data for Refractory, Relapsed Multiple Myeloma
New study results show longer follow-up from phase ½ MajesTEC-1 study evaluating BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses.
Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab phase 1/2 study MajesTEC-1 study.
Teclistamab is an investigational T-cell redirecting bispecific antibody targeting B-cell maturation antigen, which is being studied in individuals with refractory or relapsed multiple myeloma who have received 3 or more prior lines of therapy.
“The MajesTEC-1 study update suggests patients with relapsed or refractory multiple myeloma receiving teclistamab achieved a deep response that was also durable,” Ajay Nooka, MD, MPH, FACP, associate professor of Hematology and Medical Oncology at Emory School of Medicine, said in a statement. “These longer-term data, notably the overall response rate and progression-free survival, are encouraging in this heavily pretreated patient population,.”
As of March 2022, 165 individuals were treated with teclistamab at the recommended subcutaneous dose of 1.5 mg/kg, preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg doses across both phases 1 and 2 of the study.
At the median follow-up of 14.1 months, an overall response rate of 63% was observed in individuals with triple-class exposed multiple myeloma and a complete response (CR) or better achieved in 39.4% of individuals. The individuals in the study had 3 or more lines of prior therapy, with a median of 4 prior lines, and included an immunomodulatory drug, and anti-CD38 antibody, an immunomodulatory drug, and a prior proteasome inhibitor.
The majority of individuals were triple-class refractory and/or refractory to their last line of treatment. Although the response duration data was not yet mature, the median duration of response time to date is 18.4 months. However, it was not yet reached in individuals who achieved a CR or better.
This suggests that the response to teclistamab was durable and deepened over time, investigators said.
The medium progression-free survival was 11.3 months. Adverse events (AEs) were mostly low grade and manageable, with no new safety signals observed. Additionally, no new safety signals were observed with the longer follow-up.
In the 14.1-month follow-up data presented at ASCO the most common grade 3 and 4 hematologic AEs were anemia, lymphopenia, neutropenia, and thrombocytopenia. Infections occurred in 76.4% of individuals.
Further, the most common nonhematological AE was cytokine release syndrome (CRS), all of which were grade 1 or 2, except for 1 transient grade 3 CRS. The median time to CRS onset was 2 days, ranging from 1 to 6 days and the median duration was 2 days, ranging from 1 to 9 days.
There were 5 treatment-related deaths, and dose reductions and discontinuations because of AEs were infrequent.
The findings were presented as an oral session during the 2022 American Society of Clinical Oncology Annual Meeting (ASCO). Additional posters were also presented on teclistamab as a monotherapy and in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro).
The results from the study were also published online in The New England Journal of Medicine.
Updated data for Janssen’s bispecific teclistamab suggest continued deep and durable responses in the treatment of patients with relapsed or refractory multiple myeloma. Johnson & Johnson. News release. June 5, 2022. Accessed June 8, 2022. https://www.jnj.com/updated-data-for-janssens-bispecific-teclistamab-suggest-continued-deep-and-durable-responses-in-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma