Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
Data show a combination of teclistamab (BCMAxCD3 bispecific antibody) plus DARZALEX® (daratumumab) subcutaneous (SC) formulation improved clinical efficacy in heavily pretreated patients with relapsed or refractory multiple myeloma1
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study (NCT04108195).1 Teclistamab, an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 on T-cells, is being studied in combination with the anti-CD38 monoclonal antibody, DARZALEX (daratumumab) subcutaneous (SC) formulation, in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1 Patients in the study, including a high proportion with prior anti-CD38 monoclonal antibody exposure, achieved encouraging overall response rates (ORR) with this combination treatment.1 These data will be presented at the 2022 European Hematology Association (EHA) Annual Congress as an oral presentation on Sunday, 12 June (Abstract S188).
Latest Aithority Insights: Xage Releases Novel Multi-Layer Multi-Factor Authentication Protection for Critical Infrastructure
“For nearly 20 years, we have been committed to overcoming multiple myeloma and an important part of our strategy is to continue to invest and develop complementary and combinable regimens that improve outcomes for patients and their caregivers”
At a median follow-up of 8.6 months (range, 0.3-19.6), 76.5 percent (39/51) of response-evaluable patients enrolled in the study achieved a response, including 36 patients (70.6 percent) who achieved a very good partial response (VGPR) or better.1 In patients with prior anti-CD38 exposure, an ORR of 73.7 percent was achieved.1 The median time to first confirmed response was one month, and responses remained durable and deepened over time.1 At the analysis cut-off, 66.7 percent of patients who achieved a response (26/39) were alive and continuing on therapy.1
“Responders to the combination of teclistamab plus subcutaneous daratumumab included patients with prior exposure to BCMA or anti-CD38 targeted agents, which is encouraging,” said Paula Rodríguez-Otero†, M.D., Ph.D., Department of Hematology, Clínica Universidad de Navarra, Pamplona, Spain and principal study investigator. “These data also suggest this steroid-sparing regimen may lead to a clinically efficacious regimen in highly refractory patients.”
The open-label, multicentre, multicohort Phase 1b TriMM-2 study is investigating the safety and efficacy of teclistamab in combination with daratumumab SC for patients with RRMM.1 Enrolled patients received a median of five prior lines of therapy, 58.5 percent were triple-class refractory, 30.8 percent were penta-drug refractory, and 63.1 percent were refractory to anti-CD38 treatment.1 Eighty percent of patients were refractory to their last line of therapy.1
Data Privacy and Security: Chicago Public Schools Suffers Major Data Breach Affecting 100K Accounts
As of April 6, 2022, 65 patients received daratumumab SC 1,800mg at the approved schedule plus teclistamab 1.5mg/kg weekly (QW) or 3mg/kg every other week (Q2W) subcutaneously.1 Pre-medications, including steroids, were limited to the two step-up doses and the first full dose of teclistamab.1 Treatment with the combination regimen were tolerable and no unexpected or overlapping toxicities were observed.1 The most common adverse events (AEs) were cytokine release syndrome (CRS) (67.7 percent, all Grade 1 or 2); neutropenia (49.2 percent, 41.5 percent Grade 3 or 4); and anaemia (41.5 percent, 27.7 percent Grade 3 or 4).1 One patient (two percent) had Grade 1 immune effector cell–associated neurotoxicity syndrome (ICANS) which fully resolved.1 Infections were experienced by 67.7 percent of patients (27.7 percent Grade 3 or 4).1 Four patients died from AEs, all unrelated to teclistamab or daratumumab SC treatment.1
“For nearly 20 years, we have been committed to overcoming multiple myeloma and an important part of our strategy is to continue to invest and develop complementary and combinable regimens that improve outcomes for patients and their caregivers,” said Edmond Chan MBChB M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Daratumumab has become a foundational therapy for multiple myeloma, and it is exciting to see how we can continue to grow its potential through combinations with novel treatments.”
Pharmacodynamic analyses demonstrate that the combination upregulates CD38+/CD8+ T-cells and proinflammatory cytokines, suggesting the potential for complementary activity.1 Additional studies are needed to fully understand the potential clinical benefit of this biological activity.
The efficacy and pharmacodynamic profile of teclistamab in combination with daratumumab SC in patients refractory to anti-CD38 therapy suggest that higher response rates may be observed in patients with anti-CD38 naïve or sensitive disease who are enrolling in the MajesTEC-3 study (NCT05083169).1,2 The ongoing Phase 3 MajesTEC-3 study compares the efficacy of the teclistamab-daratumumab combination with daratumumab SC in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).2 Patients in the trial must have received one to three prior lines of therapy including a proteasome inhibitor (PI) and lenalidomide; patients who have received only one prior line of therapy must be refractory to lenalidomide.2 Patients who have progressed on or within 60 days of the last dose of lenalidomide given as maintenance therapy are also included.2
“These data suggest the potential of a fully immune-based regimen for patients with heavily pretreated multiple myeloma,” said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. “We are committed to the ongoing development of this combination and other treatments for patients who remain in need of new options.”
Top Machine Learning Insights: LivePerson Collaborates with UCSC to Build the Future of Natural…
[To share your insights with us, please write to sghosh@martechseries.com]
Comments are closed.