Title: Axicabtagene ciloleucel for treating relapsed or refractory low-grade non-Hodgkin’s lymphoma [ID1685]
Funder: Department of Health and Social Care

Abstract: Lymphomas are cancers of the lymphatic system, which is part of the body’s immune system. They are divided into Hodgkin and non-Hodgkin lymphomas. Non-Hodgkin lymphomas are a heterogeneous group of conditions ranging from ‘indolent’ (lowgrade) to ‘aggressive’ (high-grade) depending on the rate at which the abnormal lymphocytes divide. Indolent lymphomas are slow growing, with long median survival times but are less likely to be cured by treatment._x000D_ _x000D_ Follicular lymphoma is the most common type of indolent non-Hodgkin lymphoma. Patients with follicular lymphoma typically present with painless, swollen lymph nodes in the neck, armpit or groin. Lymphomas are commonly staged I (best prognosis) to IV (worse prognosis). The stage of the lymphoma reflects how many groups of lymph nodes are affected, where they are in the body, and whether other organs such as the bone marrow or liver are affected. Most people present with advanced disease (stage III to IV). [1]_x000D_ _x000D_ Marginal zone lymphoma is another type of indolent non-Hodgkin lymphoma that develops from B lymphocytes that are normally found at the edge of areas of lymph node tissue. Mucosa associated lymphoid tissue (MALT) lymphoma is the most common type of marginal zone lymphoma and it most commonly affects the stomach. Nodal marginal zone lymphoma starts in the lymph nodes and splenic marginal zone lymphoma starts in the spleen but can also be found in the bloodstream.[2]_x000D_ _x000D_ In 2017, approximately 12,000 people were diagnosed with non-Hodgkin lymphoma in England, of whom around 18% had follicular lymphoma. [2],[3] The 5-year survival rate is between 80 to 90% for people with follicular lymphoma and is between 50 to 80% for marginal zone lymphoma depending on the stage of disease. [4]_x000D_ _x000D_ For untreated disease:_x000D_ • NICE technology appraisal guidance 243 recommends rituximab in combination with chemotherapy as an option for untreated symptomatic stage III and IV follicular lymphoma._x000D_ • NICE technology appraisal guidance 513 recommends obinutuzumab in combination with chemotherapy as induction treatment followed by obinutuzumab as maintenance therapy for people who have a Follicular_x000D_ Lymphoma International Prognostic Index of 2 or more._x000D_ • For people who do not have symptoms, the NICE clinical guideline for non-Hodgkin’s lymphoma recommends that rituximab is given alone, although at the time of writing this scope rituximab monotherapy did not have a marketing_x000D_ authorisation in the UK for untreated non-Hodgkin’s lymphoma._x000D_ _x000D_ For treated disease:_x000D_ • People whose disease does not respond to treatment, or relapses after treatment is completed, will usually receive a different combination chemotherapy regimen, with or without rituximab. Stem cell transplantation_x000D_ may also be considered._x000D_ • NICE technology appraisal guidance 137 recommends rituximab in combination with chemotherapy or as monotherapy for relapsed stage III or IV follicular non-Hodgkin’s lymphoma._x000D_ • NICE technology appraisal guidance 226 recommends rituximab maintenance therapy as an option for people whose follicular non-Hodgkin’s lymphoma has responded to first-line induction therapy with rituximab in_x000D_ combination with chemotherapy._x000D_ • NICE technology appraisal guidance 627 recommends lenalidomide in combination with rituximab as an option for previously treated follicular lymphoma (grade 1 to 3A) in adults._x000D_ • NICE technology appraisal guidance 629 recommends obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance as an option for treating follicular lymphoma that did not respond or progressed_x000D_ up to 6 months after treatment with rituximab or a rituximab-containing regimen._x000D_ _x000D_ References_x000D_ 1 Freedman A (2018) Follicular Lymphoma: 2018 Update on Diagnosis and Management. American Journal of Hematology 93(2): 296-305_x000D_ 2 Cancer Research UK (2014) Different types of non Hodgkin lymphoma. Accessed May 2021._x000D_ 3 Office for National Statistics (2019) Cancer registration statistics, England: 2017. Accessed May 2021._x000D_ 4 Cancer Research UK (2004–11) Non Hodgkin lymphoma survival statistics. Accessed May 2021.

Lay abstract: To appraise the clinical and cost effectiveness of axicabtagene ciloleucel within its marketing authorisation for treating relapsed or refractory low-grade non-Hodgkin lymphoma.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS