Published in the Official Gazette the determination of the Italian Medicines Agency (Aifa) on the reimbursement for use of the monoclonal antibody isatuximab in combination with the standard of care represented by carfilzomib and dexamethasone (Kd), as treatment in adult patients with multiple myeloma who have received at least one prior therapy. This is the second indication of isatuximab available in Italy in less than 12 months – reports the manufacturer Sanofi – and is based on data from the phase 3 study ‘Ikema’, a randomized, multicentre and open-label clinical trial that enrolled 302 patients with relapsed multiple myeloma in 69 centers and 16 countries. The study shows that the combination therapy with isatuximab is able to reduce the risk of disease progression or death by 47% compared to standard therapy with carfilzomib and dexamethasone (Kd).
“For a complex pathology characterized by multiple relapses such as multiple myeloma – he comments Michele Cavo, director of the ‘Seragnoli’ Institute of Hematology Irccs Aou in Bologna, principal investigator of the ‘Ikema’ study in Italy – it is essential to continue researching and experimenting with new combinations and treatment options that can prolong life expectancy with a lower risk of disease progression. This new regime – he adds – therefore goes to enrich the therapeutic options available to Italian specialists and patients with relapsed multiple myeloma who can now benefit from an effective extra weapon at the time of the first relapse “.
The AIFA provision comes following the approval by the European drug agency EMA of isatuximab in 2021. The US Food and Drug Administration (Fda) also approved this association in 2021. From October 2021, isatuximab is available in Italy as a third-line treatment, in combination with another standard of care regimen, pomalidomide and dexamethasone (pom-dex), as treatment in adult patients with relapsed and refractory multiple myeloma who have received at least two previous therapies including lenalidomide and a proteasome inhibitor and have experienced disease progression following the last therapy.
“As Sanofi we are committed to the development of innovative anticancer molecules – he comments Mariangela Amoroso, Sanofi Country Medical Lead in Italy – among others: new generation antibodies that recruit the body’s immune system by activating it specifically against cancer cells. Our research focuses mainly on four areas: non-melanoma skin cancers, lung and breast cancer and multiple myeloma which represent a considerable therapeutic challenge because it is progressive, complex and still incurable. Thanks to an articulated program of clinical studies in which our country has also been widely involved, it has been possible to make this new therapeutic solution available “.
Multiple myeloma is the second most common blood cancer, with more than 130 thousand new diagnoses every year in the world, about 39 thousand in Europe. Despite the available treatments, multiple myeloma remains an incurable malignancy that is accompanied by a significant impact on the lives of patients, mostly elderly. Indeed, most patients with multiple myeloma experience a relapse. It is defined relapsed when it recurs after a treatment or a period of remission; on the other hand, it is refractory when it does not respond or stops responding to therapy.
Isatuximab is a monoclonal antibody that binds to a specific epitope on the CD-38 receptor of cancer cells. It is designed to work through multiple mechanisms of action, including programmed death of cancer cells (apoptosis) and immunomodulatory activity. Isatuximab is also being investigated as a first-line treatment, in other Phase 3 clinical trials, in combination with the standard treatments available for multiple myeloma but is also being tested in the treatment of other haematological malignancies.