NICE publishes guidance in England & Wales recommending Zynlonta® (loncastuximab tesirine) as an additional option for adults with relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma
Sobi® in the UK today announced that the National Institute for Health and Care Excellence (NICE) has issued its Final Guidance in England and Wales recommending the use of Zynlonta (loncastuximab tesirine) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) after 2 or more systemic treatments.
The guidance, published earlier today, noted the evolving treatment pathway and the need for new treatment options for people with DLBCL and HGBCL. During the appraisal, the committee heard from patient and clinical experts who advised that as both DLBCL and HGBCL can be difficult to treat and often need intensive treatment options, having other treatment options available were important.
- DLBCL is a type of non-Hodgkin lymphoma (NHL). It develops when the body makes abnormal B lymphocytes, a type of white blood cell that normally help to fight infections, which build up in lymph nodes or other body organs.[i]
- Over 10,000 people are diagnosed with a type of NHL every year in the UK. Around one in three have DLBCL.[ii]
- DLBCL is more common in older people and rarely seen in children.ii
- HGBCL is an aggressive type of B-cell NHL characterised by rearrangements (parts of genes switch places within chromosomes) in two particular genes.[iii]
“The addition of loncastuximab tesirine to the NICE recommended options available for DLBCL and HGBCL is important news for patients with these aggressive forms of Non Hodgkin Lymphoma.” said Professor Andrew Davies, Professor of Haematological Oncology at the University of Southampton. “With its off the shelf availability, it provides additional options for patients experiencing rapid progression of disease and requiring urgent care.”
“We are delighted that another treatment is available to patients with relapsed or refractory DLBCL and HGBCL” said Dallas Pounds, Director of Services at Lymphoma Action. “It offers a new option for people where previous courses of treatment have not been effective in sending their lymphoma into remission.”
“We are delighted with the news that NICE has positively recommended this important novel treatment for patients in England and Wales.” said Sharon Hall, General Manger at Sobi UK. “As a chemotherapy-free treatment option with a manageable safety and tolerability profile, Zynlonta has the potential to fulfil an unmet need.”
About studies
Clinical evidence for loncastuximab tesirine came from LOTIS-2, a phase 2 multinational single-arm clinical study that collected data on 145 people with relapsed or refractory DLBCL, including HGBCL, following 2 or more previous systemic treatments.[iv] The primary outcome of overall response rate was 48.3%, and 24.8% of participants reached complete response.v Median overall survival was 9.53 months and median progression-free survival was 4.93 months.[v]i Most adverse reactions were mild to moderate and generally reversible and manageable v.
In the 2-year follow up data, 31% of patients who achieved a complete response remained event-free for two or more years with no new safety signals being identified. vii
About Zynlonta
Zynlonta is a novel cancer treatment that contains the active substance loncastuximab tesirine and is administered as an intravenous infusion. It has been shown to provide durable, long-term responses in heavily pre-treated patients with relapsed/refractory DLBCL.iv
Loncastuximab tesirine consist of 2 parts; an antibody (a type of protein designed to recognize and attach to a specific target) and a cytotoxic agent (a medicine able to kill cells, including cancer cells). The antibody in this medicine is designed to attach to CD19, a protein that is found on the surface of B cells. When the antibody binds to these cells, including the cancer cells, the medicine enters the cells and kills them. Zynlonta is given under supervision of a doctor experienced in giving such treatments. v
About Sobi
Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. Learn more about Sobi in the UK and the Republic of Ireland at www.sobi.com/uk/en
For more information, please contact
Louise Farmer, Patient Advocacy and Communications Manager +44 (0) 7551 430 612 Louise.farmer@sobi.com
[i] Diffuse large B cell lymphoma | non-Hodgkin lymphoma | Cancer Research UK accessed January 2023
[ii] Diffuse large B-cell lymphoma (DLBCL) - what is it, symptoms and treatment | Blood Cancer UK accessed January 2023
[iii] High-Grade B-Cell Lymphoma - Lymphoma Research Foundation accessed January 2023
[iv] Caimi PF et al. Lancet Oncol 2021; 22:790-800
[v] ZYNLONTA SmPC, https://www.medicines.org.uk/emc/product/14786/smpc#gref. [Accessed January 2024]
Vi Zinzani PL, Caimi PF, Carlo-Stella C, et al. LOTIS-2 follow-up analysis: Updated results from a Phase 2 study of loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma. Poster presented at the International Conference on Malignant Lymphoma (ICML) Virtual 2021 Congress.
Vii Caimi PF et al. Haematologica 2023 doi: 10.3324/haematol.2023.283458. Online ahead of print.
