Nuwamba 2022: Na farko bispecific B-cell maturation antigen (BCMA) -directed CD3 T-cell engaged, teklisamab-cqyv (Tecvayli, Janssen Biotech, Inc.), an ba da izini da sauri ta Cibiyar Abinci da Magunguna don manya marasa lafiya tare da koma baya ko rashin ƙarfi. myeloma wanda a baya ya karɓi aƙalla layi huɗu na jiyya, gami da mai hana proteasome, maganin immunomodulatory, da anti-CD38
MajeTEC-1 (NCT03145181; NCT04557098), hannu guda ɗaya, ƙungiyoyi masu yawa, alamar buɗaɗɗen, gwaji na tsakiya, gwada teklisamab-cqyv. Yawan tasiri ya ƙunshi marasa lafiya 110 waɗanda ba su taɓa karɓar maganin da aka yi niyya na BCMA ba kuma a baya sun karɓi aƙalla magunguna uku, kamar mai hana proteasome, maganin rigakafi, da anti-CD38 monoclonal antibody.
Adadin amsa gabaɗaya (ORR), kamar yadda kimantawa ta Kwamitin Bita Mai Zaman Kanta ta amfani da ma'auni na Ƙungiyoyin Ayyuka na Duniya na Myeloma 2016, ya zama ma'aunin sakamako na farko. ORR (95% CI: 52.1, 70.9) ya kasance 61.8%. Adadin da aka kiyasta tsawon lokacin amsawa (DOR) shine 90.6% (95% CI: 80.3%, 95.7%) a watanni 6 da 66.5% (95% CI: 38.8%, 83.9%) a cikin watanni 9 tsakanin masu amsawa tare da matsakaicin bin- har zuwa watanni 7.4.
Gargadi na Akwati don lalacewar neurologic, gami da tasirin immunological mai alaƙa da neurotoxicity, da barazanar rai ko kuma cututtukan saki na cytokine (CRS) an haɗa su a cikin bayanan da aka tsara don teclistamab-cqyv (ICANS). Marasa lafiya waɗanda suka karɓi adadin da aka nuna na teclistamab-cqyv sun sami CRS a cikin 72% na lokuta, lalacewar neurologic a cikin 57%, da ICANS a cikin 6% na lokuta. Mataki na 3 CRS ya faru a cikin 0.6% na mutane, yayin da 2.4% na marasa lafiya sun sami lalacewar Grade 3 ko 4.
Hanya guda daya tilo don samun teklisamab-cqyv shine ta hanyar taƙaitaccen shirin da ke gudana ƙarƙashin Tsarin Kima da Rage Hatsari (REMS), wanda aka sani da Tecvayli REMS, saboda hatsarori na CRS da ƙwayoyin cuta na neurologic, gami da ICANS.
Marasa lafiya na 165 a cikin jama'ar aminci suna da pyrexia, CRS, ciwon musculoskeletal, amsawar wurin allura, gajiya, kamuwa da cuta na numfashi na sama, tashin zuciya, ciwon kai, ciwon huhu, da gudawa a matsayin abubuwan da ke faruwa akai-akai (20%). Ragewar ƙwayoyin lymphocytes, raguwar neutrophils, raguwar fararen ƙwayoyin jini, raguwar haemoglobin, da raguwar platelet sune mafi yawan abubuwan rashin daidaituwa na dakin gwaje-gwaje a maki 3 zuwa 4 (20%).
Ana gudanar da Teclistemab-cqyv ta hanyar subcutaneously a cikin allurai na 0.06 mg / kg a ranar 1, 0.3 mg / kg a ranar 4, 1.5 mg / kg a ranar 7, sannan 1.5 mg / kg kowane mako har sai cutar ta ci gaba ko rashin haƙuri.
