Promising Results of TECVAYLI® and DARZALEX FASPRO® in Multiple Myeloma Treatment Revealed

Promising Results from Combined Treatment for Multiple Myeloma Patients

Johnson & Johnson recently announced remarkable findings regarding an investigational induction treatment regimen combining TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for patients newly diagnosed with multiple myeloma and eligible for transplantation. The results were revealed at the Phase 2 MajesTEC-5 study, where a notable achievement of 100% of evaluable patients achieved minimal residual disease (MRD) negativity after the induction treatment.

Study Design and Efficacy

Initial treatment in the study involved 49 patients divided into three different cohorts using a steroid-sparing strategy with a mixture of TECVAYLI® and DARZALEX FASPRO® in conjunction with lenalidomide, both with and without bortezomib. Upon completing induction therapy, all patients registered an overall response rate of 100%, indicating at least a partial response. Among the 46 patients evaluable for MRD who underwent testing after Cycle 3 and/or Cycle 6, 100% achieved MRD negativity at a threshold of 10⁻⁵ sensitivity using next-generation flow. Additionally, complete response or better (≥CR) was reached by 85.7% (42 out of 49) of the participants, marking a significant advancement in treatment efficacy.

Dr. Marc S. Raab from Heidelberg University Hospital commented on the results, highlighting the importance of effective treatments for this aggressive form of blood cancer, which progressively diminishes the immune response over time, complicating the elimination of malignant plasma cells. He emphasized the synergy between TECVAYLI® and DARZALEX FASPRO® in effectively reducing cancerous cells, promising deeper treatment responses that may benefit long-term patient outcomes.

Safety and Tolerability

An added benefit of this combined therapy lies in its safety. Data gathered from the safety analysis exhibited manageable tolerability; hematologic treatment-emergent adverse events (TEAEs) were the most frequently reported, with Grade 3/4 infections occurring in 36.7% of participants. Although 53% experienced serious TEAEs, no cases led to complete discontinuation of treatment, and no Grade 5 adverse events were reported. Notably, 65% of patients experienced cytokine release syndrome (CRS), yet all cases were classified as Grade 1 or 2, reinforcing the safety of this therapeutic approach.

In light of these findings, Dr. Jordan Schecter, Vice President and Disease Area Leader for Multiple Myeloma at Johnson & Johnson Innovative Medicine, expressed optimism about the potential of this combination therapy, particularly in earlier lines of treatment. The study's results underscore the importance of exploring TECVAYLI® in varied treatment contexts, emphasizing its promise for patient outcomes intertwined with a favorable safety profile.

The MajesTEC-5 Study Overview

The ongoing MajesTEC-5 study (NCT05695508) seeks to assess the safety and efficacy of the teclistamab-daratumumab combination among newly diagnosed transplant-eligible multiple myeloma participants. This significant clinical trial is sponsored by the German-Speaking Myeloma Multicenter Group and Deutsche Studiengruppe Multiples Myelom, further supported by Johnson & Johnson.

Background on TECVAYLI® and DARZALEX FASPRO®

TECVAYLI® received FDA approval in October 2022 as a ready-to-use treatment for adult patients enduring relapsed or refractory multiple myeloma. It employs an innovative bispecific T-cell engager mechanism to stimulate immune responses against cancer cells. By contrast, DARZALEX FASPRO®—having received approval in May 2020—remains crucial in frontline therapy for multiple myeloma patients and is recognized as the only subcutaneous CD38-directed antibody for this application. The combination of these therapies provides a multifaceted approach against multiple myeloma, exemplifying groundbreaking advancements in this therapeutic area.

The promising outcomes observed in the MajesTEC-5 study may substantially change standard treatment protocols for newly diagnosed patients facing multiple myeloma, offering renewed hope in the battle against this challenging disease.