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Tafasitamab in Combination with Lenalidomide for Treating Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

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Tafasitamab in Combination with Lenalidomide for Treating Relapsed Or Refractory Diffuse Large B-Cell Lymphoma HEALTH TECHNOLOGY BRIEFING MARCH 2020 Tafasitamab in combination with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma NIHRIO ID 10678 NICE ID 9671 Developer/Company Incyte Corp UKPS ID Not Available MorphoSys AG Licensing and Currently in phase II clinical trials. market availability plans SUMMARY Tafasitamab in combination with lenalidomide is currently in clinical development for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). DLBCL is a type of blood cancer that develops when white blood cells, called lymphocytes, grow out of control. The affected lymphocytes lose their infection-fighting ability making the body more susceptible to infection. The first symptom of DLBCL is often a painful swelling in the neck, armpit or groin but there may be other more general symptoms such as night sweats, unintentional weight loss or high temperature. Relapsed cancer refers to cancer that initially responded to treatment but then returned. Refractory cancer refers to cancer that did not respond to treatment. Tafasitamab is administered by intravenous infusion and works by blocking the protein CD19 which is widely found on the surface of B-cells (a type of lymphocytes). CD19 is considered important for B-cell signalling and therefore blocking this protein induces death in the cancerous B-cells. Lenalidomide works by altering the activity of the body’s immune system in order to attack abnormal cells. If licenced, tafasitamab This briefing reflects the evidence available at the time of writing and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes or commissioning without additional information. A version of the briefing was sent to the company for a factual accuracy check. The company was available to comment. Page 1 of 10 in combination with lenalidomide will offer an additional treatment option for patients with relapsed or refractory DLBCL. PROPOSED INDICATION Tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy as a treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) including DLBCL arising from low-grade lymphoma, and who are not eligible for, or refuse autologous stem cell transplant (ASCT).1,a TECHNOLOGY DESCRIPTION Tafasitamab (MOR208) is an investigational humanised Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab, which consists of two amino acid substitutions S239D and I332E, is intended to lead to a significant potentiation of antibody- dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumour cell killing. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19.2,3 The antigen CD19 is broadly expressed on the surface of B-cells and has been reported to enhance B-cell receptor signalling which is assumed to be important for B-cell survival. Therefore, it is considered as a potential target for the treatment of B-cell malignancies such as non- Hodgkin’s lymphoma, including DLBCL.2,4 Lenalidomide inhibits proliferation, enhances apoptosis, and prohibits the growth of blood vessels (angiogenesis) within certain haematopoietic tumour cells and enhances T-cell and Natural Killer (NK) cell-mediated immunity.5,6 Lenalidomide works by binding directly to cereblon, which in haematopoietic cells recruits substrate proteins, Aiolos and Ikaros, lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of micro-vessels, augments foetal haemoglobin production by CD34+ haematopoietic stem cells and inhibits production of pro-inflammatory cytokines (eg TNF-α and IL-6) by monocytes.6 Tafasitamab in combination with lenalidomide is currently in clinical development for the treatment of relapsed or refractory DLBCL. In the phase II clinical trial (NCT02399085; L- MIND) patients are given 12mg/kg tafasitamab by intravenous administration weekly (cycle 1-3) to bi-weekly (cycle 4 onwards) in 4 week cycles in addition to 25mg Lenalidomide by intravenous administration which is given 3 of the 4 weeks for up to 12 weeks. 1 INNOVATION AND/OR ADVANTAGES Despite the success of rituximab, resistance occurs in about half of the patients, resulting in non-response to treatment or early relapse with the original disease.7 Fc-engineering enhances binding of the Fc domain on tafasitamab to activating Fcy-receptors which has been a Information provided by MorphoSys AG Page 2 of 10 shown to enhance cytotoxicity, relative to a native non-engineered anti-CD19 antibody in vitro.3 Preclinical in vitro and in vivo data have demonstrated increased combinatorial anti-tumour effects with tafasitamab in combination with the immunomodulatory agent lenalidomide. In the phase II study L-MIND (NCT02399085) patients achieved an ORR of 60%, a complete response rate of 42.5% and a median progression-free survival of 12.1 months.8,9 DEVELOPMENT STATUS AND/OR REGULATORY DESIGNATIONS Tafasitamab does not currently have Marketing Authorisation in the EU/UK for any indication. Tafasitamab is currently in phase II and III development to treat other subtypes of NHL and leukaemia.10,11 In December 2014, tafasitamab received an orphan drug designation by the EMA for the treatment of DLBCL.12,13 Lenalidomide currently has Marketing Authorisation in the EU/UK for the following indications:6 • Multiple myeloma As monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation As combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. As combination therapy with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. • Myelodysplastic syndromes As monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to low or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion of 5q cytogenic abnormality when other therapeutic options are insufficient or inadequate. • Mantle cell lymphoma As monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma • Follicular lymphoma In combination therapy with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 -3a). The most common side effects of lenalidomide are relative to the condition for which it is used as a treatment, however common to all different approved indications is neutropenia, diarrhoea, constipation, nausea, tiredness and rash.5 In 2017, tafasitamab, in combination with lenalidomide, received a Breakthrough Therapy Designation for relapsed/refractory DLBCL by the FDA.14 Page 3 of 10 In May 2011 lenalidomide was granted an orphan drug designation by the EMA for the treatment of DLBCL.15 Lenalidomide is currently in phase III development for the treatment of:16 • myeloma • leukaemia • lymphoma • anaemia • myelodysplastic syndromes • prostate cancer • plasmacytoma • radiculopathy • melanoma • amyloidosis PATIENT GROUP DISEASE BACKGROUND Lymphoma is a cancer of the lymphatic system.17 The lymphatic system is a system of thin tubes (lymph vessels) and lymph nodes that run throughout the body.18 Clear fluid called lymph flows through the lymph vessels and contains infection-fighting white blood cells known as lymphocytes.19 The lymphatic system is an important part of our immune system as it plays a role in fighting bacteria and other infections and destroying old or abnormal cells, such as cancer cells.18 Lymphomas are categorised into two broad groups: non-Hodgkin (NHL) and Hodgkin, NHL can be further divided into over 30 different subtypes.20,21 Around 40% of NHL cases are DLBCL which is a fast growing (high grade) lymphoma subtype that develops when the body makes abnormal B lymphocytes which build up in lymph nodes or other body organs. These abnormal cells are spread out (diffuse) rather than grouped together when they are examined under a microscope.22,23 The affected lymphocytes start to divide before they are fully mature and lose their infection-fighting properties which makes the body more vulnerable to infection.19,24 Refractory NHL is when the disease has not responded to initial treatment and is getting worse or staying the same. Relapsed NHL is when the NHL initially responded to treatment but then returned.25 The lymphatic system runs throughout the entire body and therefore NHL can appear anywhere.24 The first symptom of DLBCL is often a painless swelling in the neck, armpit or groin due to enlarged lymph nodes. Sometimes other parts of the body outside the lymph nodes can also be affected such as the stomach, bowel, liver, testis, skin, brain or eye. Symptoms are directly related to the amount of pressure the lymphoma is putting on the particular body part affected.23 Some people with DLBCL may have other more general symptoms which include night sweats, unintentional weight loss or high
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