The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending TECVAYLI®▼ (teclistamab) in England and Wales as an option for treating relapsed and refractory multiple myeloma (RRMM) in adults after three or more treatments, when the myeloma has progressed on their last treatment, and only if pomalidomide plus dexamethasone (pom-dex) would otherwise be offered.1
Multiple myeloma is an incurable blood cancer and nearly all patients will relapse and require subsequent therapy.2,3
Before the NICE recommendation, patients who had received three prior therapies faced a significant lack of available effective options.1
Typically, the effectiveness of treatments diminishes with each additional therapy, and if a patient relapses after receiving three prior treatments, their average life expectancy is reduced to 9.7 months.1,4
Teclistamab is a first-in-class bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3 receptors.5,6 It works by redirecting T-cells to multiple myeloma cells and helping to destroy them.3
Latest data showed patients with RRMM who had received three previous prior therapies had a median overall survival (OS) of 22 months when treated with teclistamab and a median progression-free survival (PFS) of 11 months.1
Further data comparing teclistamab to pom-dex concluded that teclistamab decreases the risk of disease progression by 44% and reduces the risk of death by 48%.7 Teclistamab was also shown to have a tolerable safety profile; adverse events were common and included low-grade cytokine release syndrome and grade 3 or 4 cytopenia and infection, while dose reductions and discontinuations owing to adverse events were infrequent.6
Amanda Cunnington, Senior Director of Patient Access, Johnson & Johnson Innovative Medicine UK. said: “Patients with multiple myeloma face several challenges – not least coping with recurrent relapses – and it’s vital that they can access novel treatment options that offer the potential for sustained remission and improved quality of life. While this draft guidance meets the needs of the majority of patients in this situation, we are very concerned that the proposed restriction applied by NICE removes this option from a group of patients who have been waiting for this treatment to be available on the NHS. We remain committed to supporting the multiple myeloma community to find potential solutions that can improve patient outcomes.”
References:
1 National Institute for Health and Care Excellence (NICE). TECVAYLI®. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta11418/documents. Last accessed July 2024.
2 Wallington-Beddoe CT, Pitson SM. Novel therapies for multiple myeloma. Aging (Albany NY). 2017;9(8):1857-1858.
3 Pillarisetti K, Powers G, Luistro L, et al. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020;4(18):4538-4549.
4 Tsang, C et al. Real world characteristics and outcomes for triple class exposed myeloma patients on pomalidomide and dexamethasone. 2024 British Society of Haematology Meeting. 28 – 30 April 2024.
5 Hua G, Scanlan R, Straining R, Carlson DS. Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. J Adv Pract Oncol. 2023;14(2):163-171.
6 Electronic Medicines Compendium (EMC). TECVAYLI 10mg/ml solution for injection. Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/14390/smpc/print. Last accessed July 2024.
7 Popat, et al. Comparative efficacy of teclistamab versus pomalidomide plus dexamethasone for patients with triple-class exposed relapsed refractory multiple myeloma in England. 2024 European Haematology Association Annual Meeting. 13 June, 2024.
