Novemba 2022: I-bispecific B-cell maturation antigen (BCMA) yokuqala eqondiswe kwi-CD3 T-cell engager, i-teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), inikezwe ukugunyazwa okusheshisiwe yi-Food and Drug Administration ezigulini ezikhulile ezibuyelwe kabusha noma eziphikisayo eziningi. i-myeloma ngaphambili eyayithole okungenani imigqa emine yokwelapha, okuhlanganisa i-proteasome inhibitor, isidakamizwa esivimbela ukuzivikela komzimba, kanye ne-anti-CD38.
I-MajesTEC-1 (NCT03145181; NCT04557098), ingalo eyodwa, amaqembu amaningi, ilebula evulekile, isilingo sezikhungo eziningi, i-teclistamab-cqyv ehloliwe. Isibalo esisebenzayo sakhiwe iziguli eziyi-110 ezazingakaze zithole ukwelashwa okuhloswe kwe-BCMA futhi ngaphambili zazithole okungenani imithi emithathu, njenge-proteasome inhibitor, isidakamizwa esivimbela ukuzivikela komzimba, kanye ne-anti-CD38 monoclonal antibody.
Isilinganiso sokuphendula sisonke (i-ORR), njengoba sihlolwe iKomiti Lokubuyekeza Elizimele lisebenzisa imibandela ye-International Myeloma Working Group 2016, lisebenze njengesilinganiso esiyinhloko somphumela wokusebenza ngempumelelo. I-ORR (95% CI: 52.1, 70.9) yayingu-61.8%. Isilinganiso sesikhathi sokuphendula (DOR) sasingu-90.6% (95% CI: 80.3%, 95.7%) ezinyangeni ezingu-6 kanye no-66.5% (95% CI: 38.8%, 83.9%) ezinyangeni ezingu-9 phakathi kwabaphendulayo abanokulandelela okuphakathi- kuze kube yizinyanga ezingu-7.4.
Isexwayiso Esinebhokisi sokulimala kwe-neurologic, okuhlanganisa i-immunological effector cell-associated neurotoxicity, nesifo esisongela ukuphila noma esibulalayo se-cytokine release syndrome (CRS) sifakiwe olwazini olunqumayo lwe-teclistamab-cqyv (ICANS). Iziguli ezithole umthamo obonisiwe we-teclistamab-cqyv zithole i-CRS kuma-72% wamacala, ukulimala kwe-neurologic ku-57%, kanye ne-ICANS ku-6% yamacala. I-CRS yeBanga lesi-3 lenzeke ku-0.6% wabantu, kanti u-2.4% weziguli wabhekana nokulimala kwe-neurologic yeBanga lesi-3 noma lesi-4.
Okuwukuphela kwendlela yokuthola i-teclistamab-cqyv iwuhlelo olukhawulelwe oluqhutshwa ngaphansi Kwesu Lokuhlola Ubungozi kanye Nesu Lokunciphisa (REMS), olwaziwa nge-Tecvayli REMS, ngenxa yezingozi ze-CRS nobuthi be-neurologic, okuhlanganisa i-ICANS.
Iziguli ze-165 emphakathini wezokuphepha zazine-pyrexia, i-CRS, izinhlungu ze-musculoskeletal, impendulo yendawo yomjovo, ukukhathala, ukutheleleka kwepheshana lokuphefumula eliphezulu, isicanucanu, ikhanda elibuhlungu, inyumoniya, kanye nesifo sohudo njengezenzakalo eziseceleni ezivame kakhulu (20%). Ukwehla kwama-lymphocyte, ukwehla kwama-neutrophils, ukuncipha kwamangqamuzana amhlophe egazi, ukuncipha kwe-hemoglobin, nokuncipha kwama-platelet kwakuyizinto ezivame kakhulu ezingavamile zaselabhorethri kuBanga lesi-3 kuya ku-4 (20%).
I-Teclistemab-cqyv ilawulwa ngaphansi kwesikhumba ngemithamo engu-0.06 mg/kg ngosuku loku-1, u-0.3 mg/kg ngoSuku 4, u-1.5 mg/kg ngoSuku 7, bese kuba ngu-1.5 mg/kg isonto ngalinye kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki.
