2023-09-18 12:05:19
The bispecific monoclonal antibody mosunetuzumab is now available and reimbursed also in Italy for the treatment of adult patients suffering from relapsed or refractory follicular lymphoma (LF) who have undergone at least two previous systemic therapies. This important approval comes in conjunction with World Lymphoma Awareness Day, celebrated on September 15th. This was announced by Roche, a biotechnology company that has been developing drugs for patients suffering from malignant and non-malignant haematological diseases for over 20 years.
The high clinical need – we read in a note – is demonstrated by the fact that for the majority of patients with follicular lymphoma relapse within five years of initial treatment and for those who have received two or more previous therapies, conventional treatment options are currently limited and are associated with low response rates and short duration. Mosunetuzamab is the first CD20xCD3 bispecific monoclonal antibody to be approved for the treatment of non-Hodgkin’s lymphoma (NHL). Monotherapy, ready to use, has a fixed duration scheme, which can be modulated for each patient based on the response obtained (8 cycles of 21 days up to a maximum of 17 cycles).
The approval is supported by the results of the multicenter, open-label phase I/II pivotal study GO29781 (NCT02500407), consisting of a dose escalation cohort and an expansion cohort, aiming to evaluate the safety, efficacy and the pharmacokinetics of Lunsumio* (mosunetuzumab) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Study endpoints included complete response rate as assessed by an independent review board – Irf (as primary endpoint), objective response rate, duration of response, progression-free survival, safety and tolerability (as endpoint secondary). Mosunetuzumab is a manageable bispecific – continues the note – Cytokine release syndrome (Crs) was the most frequent adverse event (44%), almost all of which was mild and reversible. In fact, all Crs events have been resolved.
“Thanks to the possibility of treating patients in the context of compassionate use activated in Italy, I had the opportunity to appreciate the effectiveness of mosunetuzumab also in real life, observing rapid and long-lasting responses despite the patients being heavily treated multiple times – declared Pier Luigi Zinzani, full professor of Hematology at the University of Bologna -. In the latest study update, presented at the Eha and Icml summer conferences, the overall survival of patients in complete response at the end of treatment is 100% at two years of follow-up, suggesting a significant clinical impact of mozunetuzumab on the typical course of relapsed/refractory follicular lymphoma”.
“Having obtained the reimbursement of mosunetuzumab also in Italy represents an important contribution for the management of some patients with multi-treated or refractory follicular lymphoma, in whom several previous lines of therapy have failed and for whom there is a need to make new effective and manageable ones available treatments – the comment of Professor Marco Ladetto, Director of the Complex Hematology Structure A Alessandria University management of the SS Antonio e Biagio and Cesare Arrigo Hospital of Alessandria – We therefore now have a new immunotherapy approach available, free of chemotherapy and of fixed duration , which has the potential to induce complete remissions in a high percentage of patients.”
“The treatment of follicular lymphomas is a clinical challenge at all stages given the possibility of recurrence – concludes Anna Maria Porrini, Medical Affairs & Clinical Operations Head Roche Italia – expanding third-line treatment options is important to increase the probability of obtaining significant clinical benefits for patients. We are therefore pleased to have received the approval of the reimbursement of the first bispecific from Aifa because this treatment can offer new hope to patients affected by follicular lymphoma”.
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