Tecvayli (teclistamab) has been recommended for relapsed and refractory multiple myeloma (RRMM) in England and Wales, leading analysts to predict Johnson & Johnson (J&J) will dominate the bispecific T-cell engagers (BiTEs) market by 2030.

The UK National Institute for Health and Care Excellence (NICE) recommended teclistamab use 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.

BiTEs are a novel class of cancer therapeutics that simultaneously bind to a distinct antigen on tumour cells and a surface molecule on T-cells, crosslinking these different cell types. Via T-cell engagement, BiTEs activate the immune system, resulting in the death of a tumour cell.

Currently, there are nine approved BiTEs globally. Eight of these drugs received their first approval in 2022, highlighting the very recent acceptance of this molecule type.

By 2030, GlobalData predicts BiTEs to generate $20.6 billion, an increase of 1,320% from 2023. The analysts also forecast that J&J’s products Tecvayli and Talvey will become the two top-selling BiTEs by 2030, encompassing 40% of all sales in this category.

Jasper Morley, Pharma Analyst at GlobalData, commented: “By 2030, Tecvayli is forecast to be the top-selling BiTE, with $6.4 billion in global sales. Talvey is estimated to become the second top-selling BiTE, with $2 billion. These two top-selling BiTEs are forecast to collectively generate $8.4 billion for J&J, an 854% increase from the forecast values of 2024.

“Despite marketing three drugs compared to J&J’s two, Roche’s total BiTE portfolio is forecast to be one-third the value of J&J’s portfolio, highlighting the dominance and estimated success of Tecvayli and Talvey.”

48% reduced risk of death

The NICE recommendation was based on data that showed patients with RRMM who had received three previous prior therapies had a median overall survival of 22 months when treated with teclistamab and a median progression-free survival of 11 months.

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%.

“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,” said Amanda Cunnington, Senior Director of Patient Access, J&J Innovative Medicine UK.

“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.”

Diana Spencer, Senior Digital Content Editor, DDW