Teclistamab, a humanized bispecific antibody, developed by Johnson & Johnson, is now reimbursed in Italy. The drug administered subcutaneously is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last therapy. This is the first and currently only bispecific antibody to be reimbursed to date in our country for the treatment of multiple myeloma, the company announced in a note.
Multiple myeloma – remember – is a rare blood cancer that originates in the bone marrow and is caused by the uncontrolled proliferation of plasma cells. It is a disease that affects approximately 6,000 people every year, with 38% of diagnoses occurring after the age of 70 and only 2% under the age of 40. The clinical picture of this disease is heterogeneous and may be characterized by bone pain, renal damage, hypercalcemia, anemia-related asthenia, and infections. The clinical history of patients with multiple myeloma is characterized by phases of remission induced by anti-myeloma therapies and phases of active disease caused by drug resistance acquired by tumor cells.
“One of the main challenges when we talk about multiple myeloma is the management of the disease in an advanced stage, when patients often become refractory to the main classes of drugs used in the first-line treatment – explains Alessandra Romano, associate professor of hematology, University of Catania, University Hospital Policlinico G. Rodolico – San Marco – The arrival of teclistamab in Italy therefore represents a significant step forward for a category of patients who, until now, had few therapeutic alternatives and with responses that were not always adequate as demonstrated by the data in the literature. In this sense, the challenge of scientific research consists in the development of new strategies that allow obtaining deep and long-lasting responses in such an advanced phase of the disease, just as demonstrated in the clinical studies of teclistamab in all subgroups. of patients analyzed”.
Teclistamab is a bispecific antibody, a therapy designed to bind diseased cells on the one hand, in this case myeloma, in a very selective manner, and the cells of the immune system on the other, allowing these two cells to come into contact, thus helping the immune system to fight the tumor itself. In particular, teclistamab binds, respectively, to BCMA on myeloma cells and to CD3 on T cells.
“This new therapy represents one of the most advanced frontiers of immunotherapy, with excellent results in terms of efficacy. In clinical practice – underlines Francesca Gay, associate professor of hematology, University of Turin, University Division of Hematology of the City Hospital of Health and Science of Turin – the subcutaneous administration route represents an advantage for both patients and professionals as, although an initial monitoring phase is necessary in hospital, the therapy can subsequently be practiced in a day hospital environment”. Today, thanks to scientific research, “the expansion of therapeutic choices for myeloma allows for greater personalization of therapy, based not only on efficacy, but also considering the safety profile and practical aspects such as the method of administration, which are relevant factors for the daily life of patients – adds Gay – Therapies based on immune effector cells, such as teclistamab, have shown extremely promising results in the treatment of myeloma patients even in the advanced stages of the disease and, by integrating with other targeted therapies or immunotherapies, could offer increasingly effective solutions in the different phases of the disease.”
“We hope that access to this and other innovative therapies can be increasingly rapid and equitable throughout the national territory”, comments Rosalba Barbieri, national vice-president of the Italian Association against leukemia, lymphoma and myeloma.
The efficacy and safety of teclistamab – details the note – were determined by the multicenter open-label phase 1 MajesTEC-1 study, the most updated data of which were presented at the last Congress of the American Society of Clinical Oncology (Asco) , showing an overall response rate (Orr) of 63 percent, with increasingly deeper responses (95 percent confidence interval). Nearly one in two patients treated with teclistamab achieved a complete response (Cr) or better. In these cases, the median duration of response (mDor), median progression-free survival (mPfs), and median overall response rate (mOs) have not yet been reached. Instead, the 30-month DOR, PFS, and OS rates were estimated to be 61, 61, and 74%, respectively.
“For over 30 years Johnson & Johnson has been investing in scientific research for the development of innovative drugs that respond to the unmet clinical needs of patients and to be alongside doctors in the treatment of solid and hematological tumors – – declares Danilo Arienti, Therapeutic Area Medical Head Hematology Johnson & Johnson Innovative Medicine Italy – Our goal is to improve and prolong patients’ lives by making our innovative therapies accessible to patients as quickly as possible, as demonstrated by our choice last year to advance the availability of teclistamab in CNN band (non-negotiated price) with early patient access programs. Aifa’s decision to make this therapy reimbursable therefore represents a further step forward in increasing the therapeutic options available to those patients who, unfortunately, until today. they had limited possibilities and with not always adequate responses. Precisely to respond to this need, our pipeline, in continuous development and evolution, aims to offer increasingly specific treatments for the different needs of patients with multiple myeloma”.
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