The Italian Medicines Agency has given the green light to the reimbursement of a new treatment for patients with diffuse large B-cell lymphoma, the most common form of non-Hodgkin’s lymphoma, who do not respond to first-line therapies, which they cannot address. a stem cell transplant or having a disease recurrence. It is a conjugated antibody, polatuzumab vedotin, the first of a new class of drugs: the therapy involves its administration in combination with bendamustine and rituximab and has been shown to be able to increase both complete remissions and their duration, and overall survival.
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Relapsed or refractory disease in 40% of cases
Diffuse large B-cell lymphoma accounts for 30% -48% of non-Hodgkin’s lymphoma cases and 60% of aggressive lymphomas worldwide. In Italy an annual incidence of about 5,000 new cases is estimated and generally occurs in people over the age of 60. After the first treatment, the disease becomes relapsed or refractory in 40% of patients and, when this occurs, treatment options are reduced, as well as survival.
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The standard first-line treatment for non-high-risk patients, the R-CHOP immuno-chemotherapy regimen (rituximab in combination with cyclophosphamide, adriamycin, vincristine and prednisone), is effective in approximately 2/3 of those receiving it. But if first-line therapy fails, for second-line patients ineligible for autologous stem cell transplantation due to age, comorbidity, or chemo-refractory, and for all beyond second-line, the current therapeutic approach is predominantly palliative type. Furthermore, refractory patients who progress on first-line therapy achieve very poor results even after receiving further treatment followed by an autologous transplant, with a 3-year progression-free survival rate of 17%. “Fragile patients who do not respond to the first lines of treatment or experience the reappearance of the disease are in a state of profound anxiety and disillusionment”, explains Davide Petruzzelli, President of La Lamp di Aladino Onlus: “The reimbursement of polatuzumab vedotin in combination with bendamustine and rituximab is therefore very important for them”.
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“We are talking about a group of patients with a very poor prognosis, for whom until now the therapeutic alternatives available have led to decidedly disappointing results”, he adds. Monica Balzarotti, Oncohematologist at the IRCCS Istituto Clinico Humanitas in Milan: “Thanks to an acceptable safety profile, good handling and efficacy data supported by solid evidence, the community of haematologists and patients with DLBCL can have a therapeutic weapon additional, which has the potential to significantly improve current treatment strategies, allowing for an increase in complete remissions and their duration, and ultimately in survival ”.
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I study
The efficacy of polatuzumab vedotin (the drug-conjugated anti-CD79b antibody, parent of its therapeutic class) in combination with bendamustine and rituximab (BR) was demonstrated in a phase Ib / II study. The results show a 58% reduction in the risk of death in patients treated with the combination compared to those receiving BR alone, and a median overall survival over 2.5 times higher (12.4 months for the combination versus 4.7 months of treatment with BR). Data from the extension cohort of other patients treated with the polatuzumab vedotin-BR combination strengthen the efficacy and safety profile of therapy in a larger patient population, demonstrating greater benefit in the second line of treatment, a median overall survival of 18 , 4 months and a median progression-free survival of 11.5 months.
The next steps
Now the researchers hope that the molecule polatuzumab vedotin could bring its benefits to an even wider population of patients with this disease, also obtaining the indication at the forefront. According to the data presented at the last Congress of the American Society of Hematology, in fact, polatuzumab vedotin in combination with the R-Chp chemotherapy regimen (rituximab plus cyclophosphamide, doxorubicin and prednisone) represents the first treatment that in 20 years has brought a significant clinical benefit. in patients with intermediate and high first-line risk, with a 27% reduction in the risk of disease progression or death. “Thanks to scientific research, it is now possible to take important steps forward in the treatment of complex and aggressive diseases such as diffuse large B cell lymphoma”, concludes Sergio Amadori, President of the Italian Association against Lymphomas, Leukemias and Myeloma: “However, it is necessary that the innovations be made accessible quickly to patients, offering more therapeutic opportunities than in the past, especially in cases where the alternatives available are limited “.
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