November 2022: Yekutanga bispecific B-cell maturation antigen (BCMA) -yakanangidzirwa CD3 T-cell engager, teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), yakapihwa kukurumidza kubvumidzwa neChikafu neDrug Administration kuvarwere vakuru vane kudzoka kana kuramba akawanda. myeloma uyo akambowana mitsara mina yekurapa, kusanganisira proteasome inhibitor, immunomodulatory drug, uye anti-CD38.
MajesTEC-1 (NCT03145181; NCT04557098), ruoko rumwechete, ruzhinji-cohort, rakavhurika-label, multi-center trial, tested teclistamab-cqyv. Kubudirira kwehuwandu hunosanganisira varwere ve110 vakanga vasati vawana BCMA-yakananga kurapwa uye vakambogamuchira mishonga inokwana mitatu, yakadai seproteasome inhibitor, immunomodulatory drug, uye anti-CD38 monoclonal antibody.
Yese mhinduro mwero (ORR), sekuongororwa neiyo Independent Review Committee ongororo uchishandisa International Myeloma Working Group 2016 maitiro, yakashanda seyekutanga efficacy mhedzisiro chiyero. Iyo ORR (95% CI: 52.1, 70.9) yaive 61.8%. Iyo inofungidzirwa nguva yekupindura (DOR) chiyero chaive 90.6% (95% CI: 80.3%, 95.7%) pamwedzi mitanhatu uye 6% (66.5% CI: 95%, 38.8%) mumwedzi ye83.9 pakati pevakapindura vane yepakati yekutevera- kusvika kumwedzi 9.
Yambiro Yebhokisi yekukuvara kwepfungwa, kusanganisira immunological effector cell-associated neurotoxicity, uye inouraya kana inouraya cytokine release syndrome (CRS) inosanganisirwa muruzivo rwekutemerwa kwe teclistamab-cqyv (ICANS). Varwere vakagamuchira iyo yakaratidza dosi ye teclistamab-cqyv vakawana CRS mu72% yezviitiko, neurologic kukuvara mu57%, uye ICANS mu6% yemakesi. Giredhi 3 CRS yakaitika mu0.6% yevanhu, nepo 2.4% yevarwere vakawana Giredhi 3 kana 4 neurologic kukuvara.
Nzira chete yekuwana teclistamab-cqyv iri kuburikidza nechirongwa chinorambidzwa chinoitwa pasi peRisk Evaluation uye Mitigation Strategy (REMS), inozivikanwa seTecvayli REMS, nekuda kwenjodzi dzeCRS uye neurologic toxicity, kusanganisira ICANS.
Varwere ve165 muhuwandu hwakachengeteka vaive nepyrexia, CRS, kurwadziwa kwemusculoskeletal, mhinduro yenzvimbo yejekiseni, kupera simba, hutachiona hwepamusoro hwekufema, kusvotwa, musoro, mabayo, uye manyoka sezviitiko zvinowanzoitika (20%). Kudonha kwemalymphocyte, kuderera kweneutrophils, kuderera kwemasero machena eropa, kuderera kwehemoglobin, uye kuderera kwemaplatelet ndizvo zvaive zvakanyanya kupararira murabhoritari yeGrade 3 kusvika 4 (20%).
Teclistemab-cqyv inobatwa pasi pedosi ye 0.06 mg/kg paZuva 1, 0.3 mg/kg paZuva 4, 1.5 mg/kg paZuva 7, uyezve 1.5 mg/kg vhiki yoga yoga kusvikira kufambira mberi kwechirwere kana huturu husingashiviriri.
