New teclistamab data presented at the 2022 ASCO annual meeting report longer follow-up from phase 1/II MajesTEC-1 study evaluating the BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/II MajesTEC-1 study .
Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), which is being studied in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy. The data were featured as part of an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
Additional poster presentations featured data on teclistamab as a monotherapy, as well as in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj). Applications seeking approval of teclistamab are currently under health authority review in the U.S. and Europe.
The multicohort, open-label, Phase 1/II MajesTEC-1 study is investigating the safety and efficacy of teclistamab in patients with RRMM who received at least three prior lines of therapy. As of March 2022, 165 patients were treated with teclistamab at the recommended subcutaneous (SC) Phase II dose (RP2D) of 1.5 mg/kg preceded by step-up doses of 0.06 and 0.3 mg/kg across both Phase 1 (NCT03145181) and Phase II (NCT04557098) of the study.
Longer Follow-up from MajesTEC-1 Study in Patients with Triple Class Exposed Multiple Myeloma (Abstract #8007): At a median follow-up of 14.1 months (0.26–24.4), an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI], range, 55.2–70.4) was observed in patients with triple class exposed multiple myeloma, with a complete response (CR) or better achieved in 39.4 percent of patients. Study participants had three or more prior lines of therapy, with a median of five prior lines, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 antibody. The majority of patients were triple-class refractory and/or refractory to their last line of treatment. Although response duration data are not mature, the median duration of response at this time is 18.4 months and has not been reached in patients who achieved a CR or better (95 percent CI, 14.9 not estimable). This suggests responses to teclistamab were durable and deepened over time.
The medium progression-free survival (PFS) was 11.3 months (95 percent CI, 8.8–17.1) . Adverse events (AEs) were low-grade for the most part and manageable with no new safety signals seen.
These results from the MajesTEC-1 study were also simultaneously published online in The New England Journal of Medicine.
See- Moreau P et al. "Teclistamab, a BCMAxCD3 antibody, in triple class exposed multiple myeloma". The New England Journal of Medicine, June 2022.