August 2023: Talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) waxaa siisay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka ee daaweynta dadka qaangaarka ah ee soo noqnoqda ama soo noqnoqda ee myeloma kuwaas oo maray ugu yaraan afar xariiq oo hore oo daaweyn ah, oo ay ku jiraan proteasome inhibitor, immunomodulatory. daroogada, iyo anti-CD38 monoclonal antibody.
Hal-gacan, calaamad furan, cilmi-baaris badan oo la yiraahdo MMY1001 (MonumentAL-1) (NCT03399799, NCT4634552) oo ay ku jiraan 187 bukaan oo hore u haystay ugu yaraan afar daawo habaysan ayaa qiimeeyay waxtarka daaweynta. Ka dib laba qiyaasood oo kor u qaadis ah todobaadkii ugu horeeyay ee daaweynta, bukaanku waxay heleen talquetamab-tgvs 0.4 mg/kg subcutaneously toddobaadle ama talquetamab-tgvs 0.8 mg/kg subcutaneously labadii toddobaadba mar (labadii toddobaadba mar), ka dib saddex tallaabo oo kor loo qaaday, ilaa uu cudurku ka sii socdo. ama sun aan loo dulqaadan karin.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR), kuwaas oo ay qiimeeyeen guddiga dib u eegista madax-bannaan ee ku salaysan tilmaamaha IMWG, ayaa ahaa cabbirada natiijada waxtarka aasaasiga ah. Bukaan-socodka hore u lahaa ugu yaraan afar xariiq oo daweyn ah, sida proteasome inhibitor, immunomodulator, iyo anti-CD38 monoclonal antibody, ayaa ka kooban dadka waxtarka leh ee aasaasiga ah. Dhexdhexaadka DOR wuxuu ahaa 9.5 bilood (95% CI: 6.5, aan la qiyaasi karin) iyo ORR ee bukaannada 100 ee qaadanaya 0.4 mg / kg todobaadkii waxay ahayd 73% (95% kalsoonida kalsoonida (CI): 63.2%, 81.4%). Dhexdhexaadka DOR ee bukaannada 87 ee qaadanaya 0.8 mg/kg labadii toddobaadba mar lama qiyaasi karo, halka ORR uu ahaa 73.6% (95% CI: 63%, 82.4%). Ilaa 85% jawaab bixiyaasha ayaa la sheegay in ay sii wadeen wax ka qabashada ugu yaraan sagaal bilood.
Digniin Sanduuqan oo loogu talagalay saamaynta isdifaaca unugyada la xidhiidha neurotoxicity (ICANS) iyo sunta neerfaha, oo ay ku jiraan nafta halis geliya ama dilaa cytokine sii daayo syndrome (CRS), waxay ku jirtaa agabka qorida ee talquetamab-tgvs. Talquetamab-tgvs waxa kaliya oo lagu bixiyaa barnaamijka xaddidan ee hoos yimaada Istaraatiijiyada Qiimaynta Khatarta iyo Yaraynta (REMS), oo loo yaqaan Tecvayli-Talvey REMS, iyadoo ay ugu wacan tahay khatarta CRS iyo sunta neerfaha, oo ay ku jirto ICANS.
Bukaannada 339 ee dadka badbaadada ah waxay la kulmeen CRS, dysgeusia, cillad cidiyaha, raaxo la'aanta muruqyada, cillad maqaarka, finan, daal, miisaan lumis, af qallayl, pyrexia, xerosis, dysphagia, caabuqa neef-mareenka sare, shuban, iyo dhacdooyin xun dalbashada (20%).
Talquetamab-tgvs waa in lagu maamulaa qiyaas ah 0.4 mg/kg todobaadkii ama 0.8 mg/kg labadii todobaadba. Jadwallada qiyaasta oo dhammaystiran waxay ku taxan yihiin macluumaadka qoritaanka.
