Using the treatment results in promising response rate in patients with heavily pretreated RRMM, according to a presentation at the 2022 ASCO annual meeting.
The Janssen Pharmaceutical Companies of Johnson & Johnson presented poster presentations with data on teclistamab as monotherapy and in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) at the American Society of Clinical Oncology (ASCO) annual meeting in 2022.
Applications for approval of teclistamab are reviewed by the health authority in Europe and the United States.
One poster presented the first results of cohort C of the MajesTEC-1 trial evaluating teclistamab for the treatment of subjects with relapsed or refractory multiple myeloma (RRMM) who had been previously exposed to anti-BCMA treatment. The subjects had received 6 prior lines of therapy, with 85% triple-class refractory and 35% penta-drug refractory.
The use of teclistamab, after previous treatment with chimeric antigen receptor T-cell (CAR-T) therapy and/or an antibody-drug conjugate (ADC) targeting BCMA, resulted in a promising response rate in patients with heavily pre-treated RRMM. At a median follow-up of 12.5 months, the overall response rate (ORR) was 52.5% in 40 subjects receiving teclistamab in cohort C.
Responses to teclistamab occurred early and deepened over time with similar response rates in subjects previously treated with ADC and/or CAR-T.
Investigators reported an acceptable safety profile in subjects previously treated with anti-BCMA treatment without discontinuations or dose reductions due to adverse reactions. The safety profile was similar to that observed in BCMA-naïve subjects with no new safety signals.
At the follow-up of 12.5 months, 65% of the subjects had infections. In addition, the most common AE was cytokine release syndrome (CRS), with a median time to onset of CRS and a duration of 2 days and 2 days, respectively. Other adverse events included anemia, lymphopenia, neutropenia, and thrombocytopenia.
In a second presentation, researchers presented study results analyzing patient-reported quality of life assessments in subjects in the MajesTEC-1 trial who had received their first treatment dose on March 18, 2021.
The metric analysis included function, including cognitive, emotional, and physical; generic health, including the ability to participate in usual activities, anxiety, depression, discomfort, mobility, pain, and self-care; symptoms, including constipation, diarrhea, fatigue, loss of appetite, nausea, pain, and vomiting; and
Researchers found that 80% of 110 subjects included in the Patient Reported Outcomes (PRO) analysis experienced a meaningful improvement, which is the percentage of subjects with a clinically meaningful change from baseline on at least 1 of the symptom scales. The reduction in pain scores occurred as early as Cycle 2.
In addition, no significant improvement was observed in the fatigue and physical function scales to date. The initial PRO results complement recent clinical data and support teclistamab as a potential turn-key T-cell redirection therapy for individuals with RRMM.
On September 7, 2021, the median duration of treatment was 5.7 months and the median follow-up was 7.8 months. Global health status scores improved significantly from baseline in Cycles 4, 6, and 8, and emotional functioning improved significantly at all time points.
The PRO ratings include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item. In addition, the PROs were assessed on day 1 of each 28-day treatment cycle.
Additional follow-up is needed to assess the full benefit of meaningful improvement in functional outcomes, the researchers said.
In addition, updated results from the Phase 1 TRIMM-2 trial were presented at a poster session at the 2022 ASCO Annual Meeting, which evaluated teclistamab in combination with daratumumab and hyaluronidase-fihj.
Daratumumab and hyaluronidase-fihj is a CD38-driven monoclonal antibody approved to be administered subcutaneously for the treatment of individuals with multiple myeloma.
In the study, individuals received an average of 5 prior lines of therapy. About 75% had been previously exposed to anti-CD38 therapies and about 63.1% were refractory to anti-CD38 treatment.
Subjects evaluated achieved an ORR of 76.5% at a median follow-up of 8.6 months.
Another poster presentation for the multicenter, ongoing, open-label, phase 3, randomized MajesTEC-3 study compared the efficacy of teclistamab in combination with daratumumab in combination with pomalidomide and dexamethasone or bortezomib dexamethasone in subjects with RRMM.
Additional data from both the talquetamab and teclistamab cohorts of the TRIMM-2 trial were presented as oral presentations at the European Hematology Association 2022 Congress, which took place from June 9, 2022 to June 12, 2022.
Updated data for Janssen’s bispecific teclistamab suggest sustained deep and durable responses in the treatment of patients with relapsed or refractory multiple myeloma. Johnson and Johnson. news item. June 5, 2022. Accessed June 9, 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