Also available in Italy, approved by Aifa, an innovative drug. Chronic the disease, lengthen the time more and more without relapse and with a better quality of life: goals that today seem closer
If today the multiple myeloma remains a disease still difficult to cure definitively, the goal of a complete eradication of the tumor is on the horizon. Meanwhile, thanks to advances in scientific research, they become available new therapies capable of prolonging and improving the lives of patients, even those with particularly aggressive forms that recur over time with relapses and tend not to respond to treatments. Just for patients with relapsed and refractory myeloma, a new therapeutic option, effective in the most advanced stages of cancer, has been approved a few weeks ago by the Italian Medicines Agency (Aifa).
The new cure available in Italy
Multiple myeloma is a blood cancer that affects over every year in Italy 5,700 people, most of whom are over 65. And the numbers are steadily increasing, along with the general aging of the population. This neoplasm, which affects the plasma cells contained in the bone marrow (whose function is to produce the antibodies necessary to fight infections), there remains a “tough nut” to fight: it is cured, but it is almost never cured. The average survival, however, has passed over the last twenty years from a few months to about seven years, but this tumor involves temporary remissions followed by relapses and nearly 9 out of 10 patients experience a relapse over time. For the treatment of the most aggressive forms of myeloma, the relapsed and refractory ones, a new therapy is now available in Italy, isatuximab. The new drug is a monoclonal antibody that binds to the CD38 receptor (a highly and uniformly expressed target on the surface of multiple myeloma cells) which is administered intravenously in combination with pomalidomide and dexamethasone to adult patients who have received at least two previous treatments (including lenalidomide and a proteasome inhibitor) and who have shown disease progression during the last therapy. The association of the three drugs has been shown to significantly reduce the risk of disease progression or death compared to the pomalidomide and dexamethasone regimen alone.
Prolongation of survival and quality of life
“Multiple myeloma is the second most prevalent onco-haematological disease and until a decade ago we had few therapeutic options available – he says Paolo Corradini, director of the Division of Hematology at the IRCCS National Cancer Institute of Milan and full professor of Hematology at the University of Milan -. In the last 10 years, however, research has introduced important changes: it is in fact the blood cancer for which there have been the greatest advances in terms of treatment and increased survival. The ICARIA clinical trial (which led to the registration of the triplet with isatuximab) was the first phase 3 study of an anti-CD38 antibody in combination with pomalidomide and dexamethasone to present results showing clinically significant benefits after at least two lines of previous therapy. We can therefore say that today we have one more treatment, capable of bringing a real benefit in terms of prolongation of survival and quality of life., even in particularly fragile and pretreated patients ». The average age of the patients is in fact about 70 years, when often people already suffer from other more or less serious ailments, and this new strategy is approved for use in the third line (i.e. after having done, over time, two different types of previous treatments): «It is therefore very important that new therapeutic strategies aim not only at quantitatively extending patient survival, but also that they are well tolerated, without excessive toxicity» adds Corradini.
Multiple myeloma does not always give obvious signs: often in the early stages the disease does not manifest itself or presents with non-specific symptoms such as fatigue and back pain. Signs that may raise suspicion are persistent or recurring bone pain (particularly in the back, hips and ribs) and brittle bones. The neoplastic plasma cells can then invade the bone marrow and stimulate the action of osteoclasts by weakening the bone tissue, which can break more easily. Also persistent fatigue and breathing difficulties they can be a wake-up call and can be due to anemia (i.e. a lack of red blood cells that are no longer sufficiently produced by the bone marrow) and kidney problems. “For asymptomatic patients there is no indication for any treatment and frequent checks are carried out to verify the possible evolution of the tumor – clarifies the expert -. Being a pathology that mostly affects after the age of 70, the treatments must in any case take into consideration the general situation of the patient ». Precisely in this perspective, the important therapeutic benefit observed also in some subgroups of particularly fragile patients, which well represent clinical practice in the real world, such as those aged 75 years or over or with renal insufficiency, assumes particular importance. This is demonstrated by the results of the ICARIA study (also published in the scientific journal The Lancet
), in which 8 Italian centers participated.
Often elderly patients
Isatuximab is also at the center of other trials, starting with the pivotal phase 3 clinical trial IKEMA, which demonstrated the efficacy of the monoclonal antibody also in the second line of treatment. The trial investigated the efficacy of combining isatuximab with carfilzomib and dexamethasone (standard-of-care regimen) and demonstrated significantly reducing the risk of disease progression or death compared to standard. In addition, the combined therapy has made it possible to reach undetectable levels of multiple myeloma in a significant percentage of patients. Last April, the European Commission approved the indication of isatuximab for the treatment of relapsed or refractory second-line multiple myeloma (expected in Italy for next year). There are also trials with the drug as a first-line treatment, in combination with the standard treatments already available. “It is of fundamental importance that patients with myeloma have access to the best treatments available according to a treatment path and protocols based on solid clinical evidence that can ensure the longest possible survival period and a decent quality of life – he comments. Aurelio July, councilor of the Association against leukemia, lymphomas and myeloma (Ail), section of Bologna -. Despite the long-awaited progress, this disease has a strong impact on an often elderly population and which therefore presents other concomitant pathologies. Ail has always been alongside clinicians and researchers to ensure the best care and support investment in research, and alongside patients and their families to amplify their voice in front of institutions and offer logistical, psychological and home assistance services. , without ever forgetting that the patient is first of all a person ».
October 13, 2021 (change October 13, 2021 | 16:43)
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