NICE lifts restriction and recommends bispecific antibody TECVAYLI®▼ (teclistamab) for all eligible patients with relapsed and refractory multiple myeloma after three treatments

Teclistamab is recommended as an option for treating relapsed and refractory multiple myeloma in adults only after three or more lines of treatment when the myeloma has progressed¹

Eligible patients throughout England and Wales are now able to access this first-in-class bispecific antibody, which has been shown to extend life-expectancy compared to previous standard of care^{1, 2}

High Wycombe, UK (10 October 2024) – Johnson & Johnson (J&J) is pleased to have received positive final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending TECVAYLI^®▼ (teclistamab) in England and Wales as an option for treating relapsed and refractory multiple myeloma (RRMM) in adults only after three or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody), when the myeloma has progressed on their last treatment.¹

This final draft guidance follows a positive but restricted Draft Guidance Consultation from NICE in July 2024 which recommended teclistamab as an option for this patient group, only if pomalidomide plus dexamethasone (pom-dex) would otherwise be offered. The restriction has been lifted following further consultation with stakeholders and a second appraisal committee meeting, which highlighted the critical unmet need in patients for whom pom-dex is not a treatment option. J&J is delighted that NICE has recognised the critical need of this patient population having access to additional treatment options that could improve prognosis.¹ The Scottish Medicines Consortium (SMC) accepted teclistamab for this patient group, without a pom-dex restriction, in September 2024.²

“This is fantastic news and a hard-earned victory for all involved. Teclistamab is the first of a new class of drugs to be approved on the NHS in England and Wales and has the potential to enable some people who have not responded well to previous treatments to experience their very first complete remission,” said Caroline Donoghue, Senior Policy Officer, blood cancer charity Myeloma UK. “Approvals like this highlight why we continue to fight for treatment, submit evidence on behalf of the myeloma community, attend committee meetings and push for access to pioneering drugs. The initial decision to impose restrictions was deeply unfair for some patients that needed it most. Over the last few weeks we have worked tirelessly to get everyone back around the table, come up with a solution, and give people with myeloma a fighting chance to spend more quality time with their loved ones. Until we have a cure, it is absolutely vital that all myeloma patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey.”

Multiple myeloma is an incurable blood cancer and nearly all patients will relapse and require subsequent therapy.^[3],[4] Before the July 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.^1,5

Teclistamab* is a first-in-class bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3 receptors.^[6],[7] It works by redirecting T-cells to multiple myeloma cells and helping to destroy them.⁴ Latest data showed patients with RRMM who had received three previous prior therapies had an overall response rate (ORR) of 63%, a median overall survival (OS) of 22.2 months when treated with teclistamab and a median progression-free survival (PFS) of 11.4 months when treated with teclistamab.¹ Further data comparing teclistamab to pom-dex concluded that teclistamab decreased the risk of disease progression or death by 44% and extended median time to next treatment (proxy for progression-free survival) by 5.36 months (12.39 versus 7.03 months; representing a 1.76-fold increase).^[8] Compared to pom-dex, teclistamab reduced the risk of death by 48% (HR of 0.52; 95% CI 0.36-0.74;p<0.001) and extended median overall survival by 12.43 months (22.21 versus 9.78 months; 2.27-fold increase).⁸ Teclistamab was also shown to have a tolerable safety profile; adverse events were common but generally manageable and included cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS) which were mostly grade 1 or 2 as well as grade 3 or 4 cytopenias and infections, while dose reductions and discontinuations owing to adverse events were infrequent.⁷

“We’re delighted that NICE has updated its recommendation to be unrestricted in this group of patients after three previous lines of treatment,” said Roz Bekker, Managing Director, Johnson & Johnson Innovative Medicine UK and Ireland. “At J&J, our teams are continuously working to get in front of the most complex diseases affecting patients and their families, but we know that these treatments only matter if patients can access them when they need them. Today’s decision enables patients in England and Wales to access the same treatments as patients in Scotland and is an excellent example of how cross-stakeholder collaboration can truly achieve positive results in advancing patient equity. We hope that such positive outcomes can continue to be seen for similar appraisals, now and in the future, to ensure UK patients can reap the full benefit of clinical progress and innovative treatment options.”

[1] National Institute for Health and Care Excellence (NICE). TECVAYLI^®▼. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta11418/documents. Last accessed October 2024.

^[2] Scottish Medicines Consortium. TECVAYLI^®▼. Available at https://scottishmedicines.org.uk/medicines-advice/teclistamab-tecvayli-full-smc2668/. Last accessed October 2024.

[3] Wallington-Beddoe CT, Pitson SM. Novel therapies for multiple myeloma. Aging (Albany NY). 2017;9(8):1857-1858.

[4] 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.

[6] 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.

[7] 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 October 2024.

[8] 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.