Jan 2023: I-Mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), i-CD20-directed CD3 T-cell engager bispecific CDXNUMX-directed CDXNUMX T-cell yeziguli zabantu abadala ezine-lymphoma (FL) ebuyele emuva noma eyi-refractory follicular lymphoma (FL) elandela imizuliswano emibili noma ngaphezulu ye-systemic therapy, ithole ukugunyazwa okusheshayo kwa-Food and Ukuphathwa Kwezidakamizwa (FDA).
Ku-GO29781 (NCT02500407), ilebula evulekile, i-multicenter, ucwaningo lwamaqoqo amaningi, i-mosunetuzumab-axgb yahlolwa. Iziguli ezingama-90 ezine-FL ebuyele emuva noma ekwazi ukumelana nezifo ebezikade zinemigqa okungenani emibili yokwelashwa okuhleliwe, okuhlanganisa i-anti-CD20 monoclonal antibody kanye ne-alkylating agent, yenze inani labantu abasebenzayo.
Izinga lokuphendula lenjongo (ORR) laliyisilinganiso esiyinhloko somphumela futhi lanqunywa indawo yokubuyekeza ezimele sisebenzisa imibandela evamile ye-non-lymphoma Hodgkin (Cheson 2007). U-60% wabaphenduli unikeze izimpendulo eziphelele, kanti i-ORR yayingu-80% (95% CI: 70, 88). Isilinganiso sesikhathi sokuphendula (DOR) sasiyizinyanga ezingama-22.8 (95% CI: 10, asifinyelelwanga) ngokulandelelwa okumaphakathi kwezinyanga eziyi-14.9 phakathi kwabaphendulayo, futhi amanani e-DOR ayeqageliwe ezinyangeni eziyi-12 nezinyanga eziyi-18 ayengu-62% no-57. %, ngokulandelana.
Isexwayiso Esinebhokisi esibucayi noma esisongela ukuphila i-cytokine release syndrome ikhona ezintweni ezinqumayo (CRS). Ubuthi be-neurologic, izifo, i-cytopenias, nokuvutha kwesimila kuphakathi kwezixwayiso nezinyathelo zokuphepha. I-Mosunetuzumab-axgb yanikezwa abantu abangu-218 abane-hematological malignancies ngethamo elinconyiwe. Kulezi ziguli, ama-39% ahlangabezane ne-CRS, ama-39% athola ubuthi be-neurologic (okuhlanganisa no-1% ne-ICANS), u-17% waba nezifo ezibalulekile, futhi u-4% waba nokuqubuka kwesimila. IBanga lesi-2 lenze ku-15%, iBanga lesi-3 ku-2%, kanye neBanga lesi-4 ku-0.5% wabahlanganyeli be-CRS.
Izimpendulo ezivame kakhulu ezingezinhle (20%) ku-218-isiguli esihlanganisiwe sokuphepha kwabantu kwakuyi-cytokine release syndrome, ukukhathala, ukuqubuka, i-pyrexia, nekhanda elibuhlungu. Ukuncipha kwesibalo se-lymphocyte, ukuncipha kwe-phosphate, ukukhuphuka kweglucose, ukuncipha kwenani le-neutrophil, ukwenyuka kwe-uric acid, ukuncipha kwenani lamangqamuzana amhlophe egazi, ukuncipha kwe-hemoglobin, kanye nokuncipha kwamaplatelet kwakuyizimo ezingavamile zaselabhorethri zeBanga lesi-3 ukuya kwelesi-4 (10%).
I-Mosunetuzumab-axgb kufanele inikezwe ngethamo elingu-1 mg ku-Cycle 1 Day 1, 2 mg ku-Cycle 1 Day 8, 60 mg ku-Cycle 1 Day 15, 60 mg ku-Cycle 2 Day 1, kanye ne-30 mg ngoSuku 1 ngokuzayo. imijikelezo. Umjikelezo wokwelapha uthatha izinsuku ezingama-21. Ngaphandle uma iziguli zibonisa ubuthi obunzima noma ukuqhubeka kwesifo, i-mosunetuzumab-axgb kufanele inikezwe imijikelezo engu-8. Iziguli ezibonise impendulo egcwele kufanele ziyeke imithi ngemva kwemijikelezo engu-8. Ngaphandle kwalapho zinezifo eziba zimbi kakhulu noma ubuthi obungabekezeleleki, iziguli ezinempendulo eyingxenye noma isifo esizinzile kufanele ziqhubeke nokwelashwa kuze kufike kumjikelezo we-17.
Buka imininingwane egcwele ye-Lunsumio.
