TECVAYLI▼ (teclistamab) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma
June 3, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – Janssen, Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, multiple myeloma
- New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing
- Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of teclistamab.
3 June 2024 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company today announced longer-term data from the pivotal phase 1/2 MajesTEC-1 study of TECVAYLI▼ (teclistamab) showing deep and durable responses in patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (TCE)a and who previously received three or more prior lines of therapy, including in patients who switched to less frequent dosing (Abstract #7540). This data was featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 31 May-4 June, in a poster presentation.
Additional presentations highlight the potential for outpatient step-up administration with prophylactic tocilizumab from the MajesTEC-1 study (Abstract #7517) and phase 2 OPTec study (Abstract #7528), as well as first results from the subgroup analysis of patients with high-risk (HR) features that will be presented at the 2024 European Hematology Association (EHA) Congress, taking place in Madrid from 13-16 June (Abstract #923). The safety run-in MajesTEC-7 study in frontline teclistamab administration (Abstract #7506) will also be presented at ASCO.
“With the longest follow-up of any bispecific antibody, teclistamab demonstrates continued deep and durable responses observed in patients with relapsed or refractory multiple myeloma who have limited treatment options,” said Niels van de Donk MD, professor of Haematology at Amsterdam University Medical Centers, The Netherlands, and principal study investigator. “The results of the MajesTEC-1 study indicate the potential of teclistamab to transform the treatment paradigm, and clinical studies are investigating whether teclistamab may be a pivotal advancement for improved care and management in the broader patient population.”
Results from the MajesTEC-1 study show that, at a median follow-up of 30.4 months, patients treated with teclistamab at the recommended phase 2 dose (RP2D)b (n=165) demonstrated an overall response rate (ORR) of 63%, with responses continuing to deepen and 46% of patients achieving a complete response (CR) or better. For patients with a CR or better, mDOR, mPFS and mOS were not yet reached, and estimated 30-month DOR, PFS and OS rates were 61%, 61% and 74%, respectively. Patients who achieved a partial response or better after a minimum of four cycles of therapy (phase 1), or maintained a CR or better for a minimum of six months (phase 2) per protocol, had the option to switch to biweekly dosing (every two weeks) (Q2W). Additionally, 37 out of 38 patients who switched to Q2W dosing maintained responses.
The safety profile remained consistent with a notable decrease in new onset of severe infections over time. Adverse events (AEs) included neutropenia (any grade, 72%; grade 3/4, 66%), anaemia (any grade, 55%; grade 3/4, 38%), thrombocytopenia (any grade, 42%; grade 3/4, 23%), lymphopenia (any grade, 36%; grade 3/4, 35%), and infections (any grade, 79%; grade 3/4, 55%). Of 22 grade 5 infections, 18 were due to COVID-19. The decrease in new onset grade 3 or greater infections may be due to switching to Q2W dosing or other factors, such as implementing the use of intravenous immunoglobulin.
“These longer-term results continue to demonstrate the benefits of less frequent dosing of teclistamab, providing eligible patients a more tailored, less burdensome option, while still achieving deep and durable responses,” said Edmond Chan MBChB MD (Res), EMEA Therapeutic Area lead Haematology, Johnson & Johnson Innovative Medicine. “Teclistamab is an important part of our multiple myeloma portfolio and highlights our commitment to providing transformational therapies as we strive towards our ultimate goal of curing multiple myeloma.”
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