For those affected by diffuse large B-cell lymphoma – the most common and aggressive form of non-Hodgkin’s lymphoma -, do not respond to first-line therapies or develop relapses, and cannot face a stem cell transplant, the Italian Agency del Farmaco (Aifa) has given the green light to the reimbursement of a new treatment. It is a monoclonal antibody, tafasitamab, enhanced to target cancer cells: the therapy involves its administration in combination with lenalidomide and has been shown to induce a positive and prolonged response in patients, leading to a partial or complete remission of the disease.
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The disease returns in one third of patients
In this type of lymphoma, which in Italy has 4,400 diagnoses each year, the B cells, a subtype of lymphocytes, become larger than normal and multiply uncontrollably. “The most frequent symptom is the rapid swelling of lymph nodes in the neck, armpits and groin, to which fever, night sweats and weight loss can be added – explains Andrés José María Ferreri, Director of the Lymphoma Unit at the IRCCS San Raffaele Hospital in Milan and President of the Italian Lymphoma Foundation (FIL) Onlus. About a third of patients fail to respond to first-line treatment or relapse, and when this occurs, treatment options diminish, as does overall survival, which is reduced to less than a year.
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The results of the new therapy
We come to the results on tafasitamab, which is administered, in fact, in association with lenalidomide, (an immunomodulatory drug against blood cancer) and acts against the tumor antigen CD-19. 3-year data from L-MIND (the Phase 2 study of 81 patients with relapsed or refractory disease who were not candidates for stem cell transplantation) demonstrated complete disease remission in 40% of patients; if those who have had an important response are also added, the figure is approximately 60% of patients. The median duration of this response was very prolonged, well over 3 years (44 months): that is, half of the patients had a longer lasting response. “A result never observed before in this group of patients – comments Pier Luigi Zinzani, full professor of Hematology at the “Seràgnoli” Hematology Institute of the University of Bologna -. We are also talking about a chemo-free regimen: a very important fact for patients, who can obtain significant results without the typical side effects of chemotherapy. Its toxicity profile, limited and well tolerated – continues Zinzani – is exclusively haematological, with the reduction of white blood cells, hemoglobin and platelets. In fact, there was no evidence of extra-haematological toxicity, i.e. cardiac, pulmonary, renal and hepatic, and this makes the treatment truly very safe”.
Prospects of care changed radically
Treatment involves the administration of intravenous tafasitamab and one tablet of lenalidomide for three consecutive weeks every other month for 12 months. If the patient benefits, treatment continues with tafasitamab alone until disease progression.
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There are several therapeutic options that have emerged in recent years for the treatment of this type of lymphoma. In addition to the possibility of optimizing second-line therapy, there is also treatment with CAR-T cells starting from the third line. “If we think about what we could offer our patients just a few years ago and what we can offer today – concludes Zinzani – it becomes clear how the treatment perspectives have radically changed”.