SMC accepts bispecific antibody TECVAYLI®▼ (teclistamab) for eligible patients with relapsed and refractory multiple myeloma

• Scotland becomes the first UK nation to accept teclistamab within its full licensed indication.
• Patients in Scotland with relapsed and refractory multiple myeloma who have received at least three prior therapies will now be able to access this first-in-class bispecific antibody which has been shown to extend their life-expectancy.
• Before today’s advice, patients in Scotland who had undergone three lines of therapy faced a significant lack
  of efficacious treatment options and a poor prognosis.

High Wycombe, UK (9 September 2024) – Johnson & Johnson is pleased to announce the Scottish Medicines Consortium (SMC) has today accepted TECVAYLI®▼ (teclistamab) in Scotland as an option for treating relapsed and refractory multiple myeloma (RRMM) in adults who 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

Multiple myeloma is an incurable blood cancer affecting approximately 500 people in Scotland each year, and nearly all patients will relapse and require subsequent therapy. 1,2,3 Before the SMC acceptance, patients in Scotland who had undergone three lines of therapy faced a significant lack of efficacious treatment options and poor prognosis. 1 Typically, the efficacy 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

Scott Purdon, Head of Patient Advocacy at blood cancer charity Myeloma UK, said: “We’re absolutely delighted. Teclistamab is part of the first new class of drugs to be approved in Scotland in seven years and could be a lifeline for people who are close to running out of treatment options. It has shown excellent results in clinical trials and allowed some people who have never responded well to treatment to experience their very first complete remission. 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.”

Teclistamab* is a first-in-class bispecific antibody that targets B-cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3) receptors.5,6 It works by redirecting T-cells to multiple myeloma cells and helping to destroy them.3 Latest data from the Phase 1/2 MajesTEC-1 study shows 63% of patients had an overall response to treatment, with
46% having a complete response or better. 7 Further data comparing teclistamab to pomalidomide plus dexamethasone (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 and included cytokine
release syndrome (72%), thrombocytopenia (40%), neutropenia (71%), pneumonia (28%), sepsis (7.9%), COVID-19 (18%), upper respiratory tract infection (37%), cellulitis (4.2%) and immune effector cell-associated neurotoxicity syndrome (ICANS) (3%), while dose reductions and discontinuations owing to adverse events were infrequent.6

“For people living with multiple myeloma, the recurring nature of the disease presents significant hurdles, highlighting the importance of access to novel treatment options that offer the potential for sustained remission and improved quality of life,” said Amanda Cunnington, Senior Director of Patient Access, Johnson & Johnson Innovative Medicine UK. “We are delighted that teclistamab has been accepted for use for the full licensed population – with Scotland being the first nation in the UK to make the treatment available on the NHS without any access restrictions. This milestone reflects J&J’s continued commitment to supporting the multiple myeloma community and improving outcomes for patients.”