Award Title: Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma [ID3795]
Funder: Department of Health and Social Care

Abstract: Lymphomas are cancers of the lymphatic system, which is a part of the immune system. Lymphomas are divided into Hodgkin lymphoma and non-Hodgkin lymphoma. Non-Hodgkin lymphomas (NHL) are a diverse group of conditions which are categorised according to the cell type affected (B-cell or T-cell), as well as the clinical features and rate of progression of the disease. The most common B-cell lymphomas are follicular lymphoma which is a slow growing, low grade form of NHL and diffuse large B-cell lymphomas (DLBCL), a fast growing, high grade form of NHL. Some follicular lymphomas transform into high grade DLBCL (transformed high grade follicular lymphoma). The symptoms differ depending on which organ or tissues are affected by the lymphoma. NHL often presents as painless lumps (enlarged lymph nodes) in the neck, armpit or groin but sometimes may start in other parts of the body such as the stomach or bowel (extranodal disease). People may also have loss of appetite, tiredness or night sweats._x000D_
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There were around 12,065 people diagnosed with NHL in England in 2017.[1] It is estimated that about 53% of people with NHL have DLBCL, which equates to around 6,391 people diagnosed with DLBCL per year.[1]_x000D_
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Most people diagnosed with DLBCL are 65 or over.[2] Although most patients are cured with first-line chemotherapy, about 10-15% have primary refractory disease and a further 20-30% relapse.[3] Survival rates at 5 years for DLBCL are around 65- 70% for stage 1 and 2 and around 50% at stages 3 and 4. [4]_x000D_
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The most widely used first-line treatment for DLBCL is R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone). Sometimes etoposide is added to this regimen. NICE guideline NG52 recommends salvage therapy, a multi-agent chemotherapy with or without rituximab, for relapsed or refractory disease in patients who are fit and eligible for subsequent stem cell transplant. Chemotherapy regimens commonly used in clinical practice include DHAP (dexamethasone, cytarabine, cisplatin), GDP (gemcitabine, dexamethasone, cisplatin), ICE (ifosfamide, carboplatin, etoposide) and IVE (ifosfamide, etoposide, epirubicin)._x000D_
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There is no established clinical management for people who have co-morbidities or are not fit enough for stem cell transplant. Further chemotherapy, with or without immunotherapy, may be used. This may include R-GemOx (rituximab, gemcitabine oxaliplatin), R-Gem (rituximab gemcitabine), R-P-MitCEBO (rituximab, prednisolone, mitoxantrone cyclophosphamide, etoposide bleomycin, vincristine), (R-)DECC (rituximab, dexamethasone, etoposide, chlorambucil, lomustine) and BR (bendamustine, rituximab)._x000D_
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NICE technology appraisal 306 (TA306) recommends pixantrone monotherapy for people who have multiply relapsed or refractory aggressive non-Hodgkin B cell lymphoma, when they have received previous treatment with rituximab and are in the third or fourth line of treatment. NICE technology appraisal 469 (TA649) recommends polatuzumab vedotin with rituximab and bendamustine as an option for treating relapsed or refractory DLBCL in adults who cannot have a haematopoietic stem cell transplant. NICE technology appraisal 559 (TA559) recommends axicabtagene ciloleucel therapy for use within the Cancer Drugs Fund as an option for treating relapsed or refractory DLBCL in adults after 2 or more systemic therapies. NICE technology appraisal 567 (TA567) recommends tisagenlecleucel therapy for use within the Cancer Drugs Fund as an option for treating relapsed or refractory DLBCL in adults after 2 or more systemic therapies._x000D_
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References_x000D_
1. Office for National Statistics. Cancer registration statistics, England. 2019. Accessed September 2021._x000D_
2. Lymphoma association. Diffuse Large B-cell lymphoma. Accessed September 2021._x000D_
3. Chaganti S, Illidge T, Barrington S, McKay P, Linton K, Cwynarski K, et al. Guidelines for the management of diffuse large B-cell lymphoma. British journal of haematology. 2016;174(1):43-56. Available from:_x000D_
https://doi.org/10.1111/bjh.14136_x000D_
4. Cancer Research UK. Non-Hodgkin lymphoma- Survival. Accessed September 2021.

Lay Abstract: To appraise the clinical and cost effectiveness of tafasitamab with lenalidomide followed by tafasitamab monotherapy within its marketing authorisation for treating adults with relapsed or refractory diffuse large B-cell lymphoma.

Research Activity Codes: 6.1 PHARMACEUTICALS
Health Categories: CANCER AND NEOPLASMS