Nofeembar 2022: Bispecific B-cell maturation antigen (BCMA) –ku hagayo CD3 T-cell engageer, tecvayli, Janssen Biotech, Inc.), waxa siisay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka ee bukaanada qaangaarka ah ee soo noqnoqday ama dib u laabatay myeloma oo hore u helay ugu yaraan afar xariiq oo daawaynta ah, oo ay ku jiraan proteasome inhibitor, daawada immunomodulatory, iyo anti-CD38
Majestec-1 (NCT03145181; NCT04557098), hal gacan, koox-kooxeedyo badan, calaamad furan, tijaabin xarun badan, la tijaabiyay teklisamab-cqyv. Dadwaynaha waxtarka leh waxay ka koobnaayeen 110 bukaan oo aan hore u helin daawaynta la beegsaday BCMA waxayna hore u heleen ugu yaraan saddex daawo, sida proteasome inhibitor, daawada immunomodulatory, iyo anti-CD38 monoclonal antibody.
Heerka jawaabta guud (ORR), sida ay qiimeeyeen qiimaynta guddiga madaxa banaan ee dib u eegista iyadoo la adeegsanayo shuruudaha Caalamiga ah ee Myeloma Working Group 2016, waxay u adeegtay cabirka natiijada waxtarka aasaasiga ah. ORR (95% CI: 52.1, 70.9) wuxuu ahaa 61.8%. Qiyaasta muddada jawaabta (DOR) waxay ahayd 90.6% (95% CI: 80.3%, 95.7%) bilaha 6 iyo 66.5% (95% CI: 38.8%, 83.9%) ee 9 bilood ka mid ah jawaab bixiyaasha leh dhexdhexaadiye - ilaa 7.4 bilood.
Digniin Sanduuqan oo loogu talagalay dhaawaca neerfaha, oo ay ku jiraan neurotoxicity-ka-xidhiidhiyaha difaaca jirka, iyo nafta-halis-gelisa ama sii-deynta cytokine syndrome (CRS) ayaa lagu soo daray macluumaadka qorista teclistamab-cqyv (ICANS). Bukaanada helay qiyaasta la tilmaamay ee teclistamab-cqyv waxay la kulmeen CRS 72% kiisaska, dhaawaca neerfaha 57%, iyo ICANS 6% kiisaska. Fasalka 3 CRS wuxuu ku dhacay 0.6% shakhsiyaadka, halka 2.4% bukaannada ay la kulmeen Fasalka 3 ama 4 dhaawaca neerfaha.
Habka kaliya ee lagu heli karo teklisamab-cqyv waa iyada oo loo marayo barnaamij xaddidan oo hoos yimaada Istaraatiijiyada Qiimaynta Khatarta iyo Yaraynta (REMS), oo loo yaqaan Tecvayli REMS, iyada oo ay ugu wacan tahay khatarta CRS iyo sunta neerfaha, oo ay ku jirto ICANS.
Bukaannada 165 ee ku jira dadka badbaadada leh waxay lahaayeen pyrexia, CRS, xanuunka murqaha, jawaabta goobta la duray, daal, caabuqa neef-mareenka sare, lallabbo, madax-xanuun, oof wareen, iyo shuban sida dhacdooyinka soo noqnoqda (20%). Hoos u dhac ku yimaada lymphocytes, hoos u dhaca neutrophils, hoos u dhaca unugyada dhiiga cad, hoos u dhaca haemoglobin, iyo hoos u dhac ku yimaada platelet ayaa ahaa cilladaha shaybaarka ee ugu badan ee fasalada 3 ilaa 4 (20%).
Teclystemab-cqyv waxa la maamulaa si hoos-hoosaad ah oo qiyaas ah 0.06 mg/kg maalinta 1, 0.3 mg/kg maalinta 4, 1.5 mg/kg maalinta 7, ka dibna 1.5 mg/kg todobaad kasta ilaa cudurku ka sii socdo ama sunta aan loo dulqaadan karin.
