TECVAYLI®▼(teclistamab) bispecific antibody approved for reimbursement in Ireland for the treatment of patients with Multiple Myeloma
Teclistamab, an off-the-shelf (ready to use) subcutaneously administered therapy, induced deep and rapid responses in triple-class exposed patients with relapsed and refractory multiple myeloma[1]
Johnson & Johnson Innovative Medicine announced today that TECVAYLI®▼ (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) has been approved for reimbursement in Ireland. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.1 The announcement follows conditional marketing authorisation (CMA) from the European Commission (EC) granted in 2022 for teclistamab, a bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.1
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.[2],[3] As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.[4] Approximately, 380 people are diagnosed with multiple myeloma each year in Ireland.[5]
Prof Siobhan Glavey, Consultant Haematologist said: “Multiple myeloma is a complex disease, and despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to three major drug classes have limited therapeutic options and generally face poor outcomes. This new treatment option has the potential to provide substantial clinical benefit and new hope to patients, with high rates of deep and durable responses as well as the added convenience of being off-the-shelf. The reimbursement of teclistamab in Ireland marks a major step towards ensuring Irish patients have access to the most innovative treatments available.”
Michaela Hagenhofer, General Manager Commercial Operations, Johnson & Johnson Innovative Medicine Ireland said: “Our ambition to eliminate multiple myeloma is stronger today than ever before. We aim to reach this goal by investing in cutting-edge innovations that address individual patient needs and offer healthcare professionals options they have not had before. We are proud to have provided early access of teclistamab to Irish patients which not only provided valuable extra time but also allowed clinicians to gain real-world experience with a bispecific. The reimbursement of teclistamab in Ireland marks exciting progress on this journey and we are proud to bring this innovation to Irish myeloma patients.”
CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.[6]
The approval was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165).1,[7],[8] Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg.1 In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy.1 Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better.1 The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9–not estimable).1
Results from the MajesTEC-1 study were also published in The New England Journal of Medicine and showed that treatment with teclistamab resulted in deep and durable responses.[9] The median duration of progression-free survival was 11.3 months (95 percent CI; range, 8.8–17.1) and the median duration of overall survival was 18.3 months (95 percent CI; range, 15.1–not estimable).9
Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4).1 Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4).1 Hypogammaglobinaemia occurred in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy.1 Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.1