The drug has proven its effectiveness in the treatment of patients in an advanced stage of the disease
Milan – Chronic the disease, lengthen the time more and more without recurrence and with a better quality of life. A goal that today seems closer even in multiple myeloma (MM), a growing disease in our country: in Italy according to the Italian Medical Oncology Association (AIOM) from 2014 to 2019 cases increased by 9%, from 5,200 to 5,700, of which 3,000 men and 2,700 women. A new therapy, isatuximab, is now available in Italy for the treatment of the most aggressive, relapsed and refractory forms of MM.
The new drug is a monoclonal antibody (mAb) directed against CD-38 which is administered intravenously in combination with pomalidomide and dexamethasone (pom-dex) to adult patients who have received at least two previous treatments (including lenalidomide and an inhibitor of the proteasome) and who have shown disease progression during the last therapy. The association, to date unique, of the three drugs has been shown to significantly reduce the risk of disease progression or death compared with the pom-dex regimen alone.
An important therapeutic benefit was also observed in some subgroups of particularly fragile patients, which well represent real-world clinical practice, such as those aged 75 or older or with kidney failure. This is demonstrated by the ICARIA-MM Phase III international pivotal clinical trial, published in The Lancet, in which 8 Italian centers participated providing an important contribution by enrolling 24 of the 307 total patients of the study.
“Multiple myeloma is the second most prevalent onco-haematological disease and until a decade ago we had few treatment options available,” he says. Paolo Corradini, Director of the Division of Hematology, IRCCS Foundation National Cancer Institute of Milan, Full Professor of Hematology at the University of Milan. “In the last 10 years, however, research has introduced important changes: it is in fact blood cancer for which there have been the greatest advances in terms of treatment and increased survival. The ICARIA-MM clinical trial was the first Phase III study of an anti-CD38 antibody in combination with pom-dex to present results showing clinically significant benefits after at least two prior lines of 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”.
Isatuximab is a monoclonal antibody that binds to the CD38 receptor, a highly and uniformly expressed target on the surface of multiple myeloma cells. The ICARIA Phase III clinical trial demonstrated that combination therapy with isatuximab provides a therapeutic benefit consistent with a statistically significant improvement in progression-free survival. Specifically, the median progression-free survival time was significantly increased in the combination arm compared to the pom-dex alone arm. The final survival result will be made available in the coming months. Meanwhile, the result of an interim analysis has been released which shows that the combination isatuximab pom-dex showed a strong trend in survival benefit compared to control.
Isatuximab is at the heart of an extensive clinical development program which is also a part of pivotal Phase III IKEMA clinical trial, which demonstrated the efficacy of the monoclonal antibody also in the second line of treatment. An important result that allows us to anticipate the use of this new option in the therapeutic continuum of multiple myeloma and increase the number of patients who can benefit from it. Specifically, the study investigated the effectiveness of combination of isatuximab with standard-of-care regimen (carfilzomib and dexamethasone) demonstrating to significantly reduce the risk of disease progression or death compared to the standard. In addition, the combined therapy has made it possible to reach undetectable levels of multiple myeloma in a significant percentage of patients. Thanks to these results, last April the European Commission approved the second indication of isatuximab, for the treatment of relapsed or refractory second-line multiple myeloma.
Isatuximab is also being tested as a frontline treatment, in other Phase III clinical trials in combination with standard treatments available for multiple myeloma therapy, as well as being trialled in the treatment of other hematological malignancies and solid tumors.
In 2020, the International Myeloma Foundation conducted a meta-analysis and study on the direct and indirect costs associated with this disease. Regarding indirect costs, some data show that the economic burden on patients and caregivers is associated with hospital visits, reduced working hours and early retirement. The loss of productivity per patient is estimated between 290,601 euros (in Spain) and 308,000 euros (in Germany).
“It is of fundamental importance that patients with MM 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 AIL-Association against Leukemia, Lymphomas and Myeloma, section of Bologna. “Despite the long-awaited progress, this disease has a strong impact on a population that is often elderly and therefore presents other morbidities. 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 other stakeholders and offer logistic assistance services. , psychological and home care, without ever forgetting that the patient is first of all a person. “
“We have a long tradition of research in hematology and oncology and never as in recent years are we concentrating our efforts on the development of innovative therapies above all, but not exclusively, in 4 main areas: non-melanoma skin cancers, lung cancer, breast cancer and multiple myeloma, ”he says Marcello Cattani, President and CEO of Sanofi Italia. “Sanofi has always taken care of patients with particularly serious pathologies and where there is a still unmet therapeutic need. Multiple myeloma, in particular, still represents a considerable therapeutic challenge today. On this front, Sanofi is also studying next-generation antibodies that recruit the body’s immune system by activating it specifically against cancer cells. We know we are not alone in this challenge. This is why we have dedicated a new edition of our call for research “RESEARCH TO CARE Onco-hematology” to Multiple Myeloma with the aim of stimulating independent research activity by supporting innovative projects that make a difference in terms of scientific knowledge, transferability to clinical practice, impact on patient care “.