Chronic lymphatic leukemia, new therapy available in Italy

The Italian Medicines Agency (Aifa) has approved the reimbursement of acalabrutinib, a new therapy for both newly diagnosed and previously treated patients with chronic lymphocytic leukemia. It is the most frequent among leukemias in adults (30% of all diagnoses) in the Western world: around 3,400 new cases are estimated every year in Italy. The pathology and the evolution in the therapeutic approach were discussed today during a press conference of AstraZeneca in Milan. “Chronic lymphocytic leukemia can have a negative impact on the quality of life of patients, who are often elderly over 70, also affected by other diseases – explains Paolo Ghia, director of the strategic research program on chronic lymphatic leukemia at the Irccs San Raffaele hospital. of Milan and full professor of medical oncology at the Vita-Salute San Raffaele University. – It is important to have new therapeutic options available such as acalabrutinib, able to control the disease in the long term and improve the quality of life. International clinical studies have highlighted the high efficacy and tolerability of acalabrutinib. “The evaluation of Aifa, in fact, examined the results of the ‘Elevate Tn’ and ‘Ascend’ pivotal clinical trials. The 4-year follow-up data of the pivotal phase III ‘Elevate-Tn’, conducted on 535 newly diagnosed patients, show that acalabrutinib reduces the risk of disease progression by more than 80% a or death compared to standard chemo-immunotherapy. In the pivotal phase III ‘Ascend’ study of 310 patients with relapsed or refractory chronic lymphocytic leukemia, acalabrutinib reduces the risk of disease progression or death by 69% compared to the control arm. “The efficacy of acalabrutinib has been demonstrated in terms of progression-free survival in all subgroups of patients, even in those with the most unfavorable genetic characteristics,” continues Ghia, who is Principal investigator in the ‘Elevate Tn’ and ‘Ascend studies. ‘at San Raffaele in Milan. “Furthermore, the improved tolerability of acalabrutinib allows the patient to be kept in long-term therapy and better control of the disease. This result is highlighted in particular by another study, comparing with the current available ibrutinib therapy, conducted on 533 high-risk refractory relapsed chronic lymphocytic leukemia patients. Acalabrutinib has been shown to be equally effective, with a lower incidence of many adverse events related to this drug class, including atrial fibrillation (9.4% with acalabrutinib versus 16% with ibrutinib). Atrial fibrillation is a cardiac arrhythmia that increases the risk of death secondary to stroke and cardiac complications, particularly dangerous in fragile patients with chronic lymphocytic leukemia “. “Acalabrutinib belongs to the class of Btk inhibitors, which has revolutionized the treatment of chronic lymphocytic leukemia – says Antonio Cuneo, director of the Hematology Operating Unit, Ferrara University Hospital -. In recent years, thanks to new therapies, survival has improved in all patients, and this result is particularly evident in those with unfavorable genetic lesions, which make them unresponsive to standard chemo-immunotherapy. Chronic lymphocytic leukemia is often diagnosed following the results of routine blood tests or done for other reasons, such as swollen lymph nodes in the neck, armpits, or groin. The white blood cell count can be high, even in the absence of specific symptoms. “” We are facing a very heterogeneous pathology and many patients have an inactive disease, without symptoms, which allows them to lead an absolutely normal life. Only in a minority of cases is immediate therapeutic intervention necessary. In asymptomatic patients at the initial stage – stresses Cuneo -, drug therapy is not implemented, but the so-called ‘watch and wait’ approach, that is ‘observe and wait’, characterized by careful monitoring of clinical and laboratory parameters, until the disease it does not become symptomatic or progress. Only in this case is the drug therapy initiated. Furthermore, with the onset of symptoms, the disease can have a negative impact on quality of life. Other aspects to consider, in addition to the symptoms, are the emotional, social and functional consequences of living with a chronic disease. Furthermore, the age of patients at diagnosis is about 70 years, chronic lymphatic leukemia is therefore part of a clinical picture where it is likely that other health problems are already present. Hence the importance of the approval of acalabrutinib, which can change the standard of care thanks to a powerful and highly selective mechanism of action ”. The oral route of administration of this class of drugs also reduces the frequency of admissions to the hospital compared to traditional chemo-immunotherapy, an advantage that is not negligible especially in the periods of greatest spread of Covid-19 infection. “We are proud that, following Aifa’s assessments, AstraZeneca research offers the scientific community and therefore patients a new therapeutic option to combat chronic lymphatic leukemia”, concludes Paola Morosini, Medical affairs head oncology AstraZeneca. “We work every day to make more and more targeted, effective treatments available with the best possible tolerability profile. The quality of life of those struggling with the disease is a priority for AstraZeneca research. Acalabrutinib is a new generation molecule, born from years of research. Our extensive development program includes over 25 clinical trials of monotherapies and combination therapies on different forms of haematological B cell tumors. of reference in this therapeutic area “.