(Adnkronos) - “Lo studio Momentum, che randomizzava pazienti che avevano ricevuto ruxolitinib ed erano anemici a ricevere momelotinib verso danazolo, una terapia ormonale androgenica che utilizziamo oggi per il controllo dell’emoglobina, ci ha consentito di ottenere un rate di indipendenza a 24 settimane del 30% verso meno del 20% con la terapia standard”. Lo afferma Francesco Passamonti, professore di Ematologia dell’università di Milano, a margine della conferenza stampa organizzata a Milano da Gsk in occasione del via libera di Aifa alla rimborsabilità di momelotinib, inibitore selettivo delle proteine JAK1 e JAK2, per il trattamento della mielofibrosi, un tumore particolarmente aggressivo del sangue che colpisce il midollo osseo, impedendogli di formare correttamente globuli rossi, globuli bianchi e piastrine.
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00:00FAMC has been developed through three very important studies.
00:08Simplify 1, developed in patients with naïve GEC inhibitors,
00:12randomized momelotin to ruxolitin,
00:15and has shown that momelotin is more effective in improving hemoglobin levels.
00:21The second study is Simplify 2, which randomizes patients who have already received GEC inhibitors,
00:27and therefore for the second line,
00:29randomized against the best treatment available at that time,
00:33which have shown an efficacy of FAMC in the control of sphenomegaly,
00:37symptoms and also the improvement of hemoglobin.
00:41The third very important study is the Momentum study,
00:44which randomizes patients who had received ruxolitin and were naïve
00:49to receive momelotin to danazol,
00:52which is an androgenic hormone therapy that we use today for the control of hemoglobin.
00:57This study has allowed us to obtain a rate,
01:00a percentage of dissociative independence at 24 weeks,
01:04of 30% to less than 20% with standard therapy.
01:08So, globally, the effectiveness in the respect of milk,
01:12of the symptoms and of hemoglobin has been documented in these three studies.
01:16From the point of view of tolerability, we can say that FAMC is very tolerant,
01:21there are no adverse events to report with, let's say, a particular stress,
01:27very important, as with other inhibitors,
01:30a certain attention on the risk of infection,
01:33because the inhibition also leads to a reduction of some subtypes of lymphocytes,
01:38which can predispose to certain infections.
01:41So, it is important to vaccinate the patients,
01:44it is important to give the information to the patients about the risk of infection,
01:47so that the management is as safe and secure as possible.