Agusta 2023: Talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) An ba da izini da sauri ta Cibiyar Abinci da Magunguna don kula da manya tare da sake dawo da myeloma da yawa waɗanda suka sha aƙalla layin jiyya guda huɗu, gami da mai hana proteasome, immunomodulatory. da miyagun ƙwayoyi, da kuma anti-CD38 monoclonal antibody.
Hannun hannu guda ɗaya, alamar buɗewa, bincike mai yawa da ake kira MMY1001 (MonumentAL-1) (NCT03399799, NCT4634552) wanda ya haɗa da marasa lafiya 187 waɗanda a baya suna da aƙalla magungunan tsarin guda huɗu sun tantance ingancin magani. Bayan matakan mataki biyu a farkon makon farko na jiyya, marasa lafiya sun karɓi talquetamab-tgvs 0.4 mg / kg subcutaneously mako-mako ko talquetamab-tgvs 0.8 mg/kg subcutaneously biweekly (kowane makonni biyu), bin matakan mataki uku, har sai cutar ta ci gaba. ko guba mara jurewa.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), waɗanda kwamitin bita mai zaman kansa ya kimanta bisa jagororin IMWG, sune matakan ingantaccen sakamako na farko. Marasa lafiya waɗanda a baya suna da aƙalla layi huɗu na jiyya, irin su proteasome inhibitor, immunomodulator, da anti-CD38 monoclonal antibody, sun haɗa da yawan inganci na farko. Matsakaicin DOR shine watanni 9.5 (95% CI: 6.5, ba ƙididdiga ba) da kuma ORR a cikin marasa lafiya na 100 da ke ɗaukar 0.4 mg / kg mako-mako shine 73% (95% tazarar amincewa (CI): 63.2%, 81.4%). Matsakaicin DOR a cikin marasa lafiya 87 da ke ɗaukar 0.8 mg/kg a kowane mako ba a ƙididdige su ba, yayin da ORR ya kasance 73.6% (95% CI: 63%, 82.4%). Kimanin kashi 85% na masu amsa an bayar da rahoton sun ci gaba da ba da amsa na akalla watanni tara.
Gargaɗi na Akwati don tasirin rigakafi mai alaƙa da neurotoxicity (ICANS) da ƙwayar cuta ta neurologic, gami da barazanar rai ko mai kisa. cytokine saki ciwo (CRS), an haɗa shi a cikin kayan rubutawa don talquetamab-tgvs. Ana ba da Talquetamab-tgvs ne kawai a cikin ƙayyadaddun shirin a ƙarƙashin Tsarin Haɗarin Haɗari da Dabarun Rage Ragewa (REMS), wanda aka sani da Tecvayli-Talvey REMS, saboda haɗarin CRS da ƙwayar cutar neurologic, gami da ICANS.
Marasa lafiya na 339 a cikin jama'ar aminci sun sami CRS, dysgeusia, matsalar ƙusa, rashin jin daɗi na musculoskeletal, matsalar fata, rash, gajiya, asarar nauyi, bushe baki, pyrexia, xerosis, dysphagia, kamuwa da cuta na numfashi na sama, zawo, da kuma abubuwan da suka faru a cikin wancan. oda (20%).
Dole ne a gudanar da Talquetamab-tgvs a kashi na ko dai 0.4 mg/kg mako-mako ko 0.8 mg/kg kowane mako. An jera cikakkun jadawali na kashi a cikin bayanan da aka tsara.
