The DREAMM-8 study
The results of the DREAMM-8 study (phase three, the last before the approval of a new treatment) indicate that in patients with relapsed or refractory multiple myeloma the addition of the drug belantamab mafodotin treatment with pomalidomide and dexamethasone is more effective in slowing the progression of the disease and reducing the risk of death compared to the current standard treatment based on bortezomib plus pomalidomide and dexamethasone. «Belantamab mafodotin is a drug-conjugated antibody that manages to selectively hit a target present on cancerous cells (the BCMA protein) and carries a powerful chemotherapy which, once released inside them, destroys them – he explains Michele Cavo, director of the Seràgnoli Institute of Hematology at the University of Bologna, among the authors of the research -. The results of this trial indicate that administering this drug together with two others already commonly used (pomalidomide, which stimulates the immune system, and dexamethasone, a steriod) significantly lengthens the time before the tumor progresses.” The trial enrolled 302 patients with relapsed or refractory multiple myeloma after at least one first-line treatment.
The risk of relapses
Multiple myeloma is a cancer That affects some cells contained in the bone marrow which have the function of producing the antibodies necessary to fight infections: plasma cells. It mainly affects people over 65 years of age: around 4,500 new cases are diagnosed every year in our country and most patients are over 50 years old. It remains a “hard nut to crack” to fight because it involves temporary remissions followed by relapses in the majority of patients, but “since the beginning of the 2000s the therapeutic approach has changed radically thanks to availability of biological drugs, non-chemotherapeutic drugs, such as immunomodulators, proteasome inhibitors and monoclonal antibodies – recalls Cavo -. Today we have available, already approved also in Italy, 20 different comprehensive treatment regimens of new drugs that can be used both for those who have just received the diagnosis and for those with a relapsed or refractory disease (i.e. one that resists treatment, ed). All these medicines have allowed us to increase not only the response ratei.e. the number of patients who benefit from therapies (which reaches up to 90% and more), but also its “depth” (therefore the share of people without minimal residual disease is growing: that is, in specific tests not even a single tumor cell is identified among 100 thousand – one million normal cells, ed.) and to extend its duration». However, new strategies are needed both to be used in patients who do not benefit from current treatments and to limit the chances of a relapse and it is in these directions that the research presented in Asco is going.
The IMROZ study
The IMROZ clinical trial is also phase three (the last before the approval of a new treatment), but has enrolled, in 21 countries and 104 centers, 446 patients with newly diagnosed multiple myeloma (who therefore had not yet received any therapy) and not eligible for a bone marrow transplant. The participants were divided into two groups: one followed the current standard therapy, i.e. the combination of the three medicines bortezomib, lenalidomide and dexamethasone (known as VRd scheme); the other group received this same therapy with the addition of isatuximab, a monoclonal antibody which binds to a specific epitope on the CD38 receptor on multiple myeloma cells, inducing specific anti-tumor activity. «The results of the IMROZ study, presented in Chicago and simultaneously published on New England Journal of Medicineshow a significant advantage in terms of survival free from disease progression and risk of death (decreases by 40%) in patients not eligible for transplant – concludes Cavo, lead author of the study for Italy -. This benefit obtained in the first line of therapy contributes to the potential global improvement in the long-term outcomes of a treatable but still non-curable disease, and with a high probability of interruption in the lines of treatment following the first. These are data that confirm the potential of isatuximab as a new cornerstone in the treatment of newly diagnosed multiple myeloma».
