Agasti 2023: I-Talquetamab-tgvs (i-Talvey, i-Janssen Biotech, Inc.) inikezwe imvume esheshayo yi-Food and Drug Administration yokwelapha abantu abadala abane-myeloma eminingi ebuyele emuva noma eyeqisayo abaye bathola imigqa yokwelashwa okungenani emine, okuhlanganisa i-proteasome inhibitor, i-immunomodulatory. umuthi, kanye ne-anti-CD38 monoclonal antibody.
Ingalo eyodwa, ilebula evulekile, ucwaningo lwe-multicenter olubizwa nge-MMY1001 (MonumentTAL-1) (NCT03399799, NCT4634552) oluhlanganisa iziguli ze-187 ezazikade zinemithi okungenani emine yesistimu ehlolwe ukusebenza kokwelashwa. Kulandela imithamo emibili ekhuphukayo evikini lokuqala lokwelashwa, iziguli zithole i-talquetamab-tgvs 0.4 mg/kg ngaphansi kwesikhumba masonto onke noma i-talquetamab-tgvs 0.8 mg/kg ngaphansi kwesikhumba biweekly (njalo emavikini amabili), kulandela imithamo emithathu yokwenyuka, kuze kube yilapho isifo siqhubeka. noma ubuthi obungabekezeleleki.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR), okuye kwahlolwa ikomidi lokubuyekeza elizimele elisekelwe kumhlahlandlela we-IMWG, kwakuyizinyathelo eziyinhloko zomphumela wokuphumelela. Iziguli ebezikade zinemigqa yokwelapha okungenani emine, njenge-proteasome inhibitor, i-immunomodulator, kanye ne-anti-CD38 monoclonal antibody, zenza inani eliyinhloko labantu abasebenzayo. I-DOR emaphakathi yayiyizinyanga ezingu-9.5 (95% CI: 6.5, ayilinganiselwe) kanye ne-ORR ezigulini ze-100 ezithatha i-0.4 mg / kg masonto onke yayiyi-73% (95% isikhawu sokuzethemba (CI): 63.2%, 81.4%). I-DOR emaphakathi ezigulini ezingama-87 ezithatha u-0.8 mg/kg njalo nge-biwe yayingalinganiselwa, kuyilapho i-ORR yayingama-73.6% (95% CI: 63%, 82.4%). Cishe u-85% wabaphenduli kubikwa ukuthi baqhubekile nokuphendula okungenani izinyanga eziyisishiyagalolunye.
Isexwayiso Esinebhokisi somphumela we-immunological effector cell-associated neurotoxicity (ICANS) nobuthi be-neurologic, okuhlanganisa ukusongela ukuphila noma okubulalayo i-cytokine release syndrome (CRS), ifakiwe kokubalulekile kokunquma kwe-talquetamab-tgvs. I-Talquetamab-tgvs inikezwa kuphela ngohlelo olukhawulelwe ngaphansi Kwesu Lokuhlola Ubungozi kanye Necebo Lokunciphisa (REMS), olwaziwa nge-Tecvayli-Talvey REMS, ngenxa yezingozi ze-CRS nobuthi be-neurologic, okuhlanganisa i-ICANS.
Iziguli ezingama-339 emphakathini wezokuphepha zathola i-CRS, i-dysgeusia, ukuphazamiseka kwezinzipho, ukungakhululeki kwemisipha namathambo, ukuqubuka kwesikhumba, ukuqubuka, ukukhathala, ukuncipha, umlomo owomile, i-pyrexia, i-xerosis, i-dysphagia, ukutheleleka komgudu wokuphefumula ophezulu, isifo sohudo, kanye nezigameko ezimbi kulokho. oda (20%).
I-Talquetamab-tgvs kufanele inikezwe ngethamo elingu-0.4 mg/kg ngesonto noma elingu-0.8 mg/kg kabili ngeviki. Amashejuli omthamo ophelele afakwe ohlwini olwazini oluchazayo.
