Noofambar 2023: Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) waa bispecific B-cell maturation antigen (BCMA)-ku hagayo CD3 T-cell kaaso ay siisay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka ee dadka qaangaarka ah ee soo noqnoqday ama soo noqnoqday myeloma badan oo qaba lahaa ugu yaraan afar xariiq oo hore oo daawaynta ah, oo ay ku jiraan proteasome inhibitor, wakiilka immunomodulatory, iyo anti-CD38 monoclonal antibody.
MagnetisMM-3 (NCT04649359), bukaanada qaba dib u soo noqoshada ama dib-u-celinta MM kuwaas oo u adkeysanaya ugu yaraan hal proteasome inhibitor, hal daawo immunomodulatory ah, iyo hal anti-CD38 antibody ayaa lagu daray calaamad furan, hal-gacan, cilmi-baaris xarun badan qiimee waxtarka. Is-diiwaangelinta, bukaanku waxay buuxiyeen shuruudaha ay dejisay Kooxda Shaqada ee Caalamiga ah ee Myeloma (IMWG) ee cudurka la ogaan karo.
Siyaabaha ugu muhiimsan ee lagu cabbiro sida wanaagsan ee wax u shaqeeyeen waxay ahaayeen heerka jawaabta ujeeddada (ORR) iyo muddada jawaabta (DOR), kuwaas oo ay heleen madax-bannaan, dib-u-eegis dhexe oo indho-la'aan ah oo raacaya tilmaamaha IMWG. Toddoba iyo sagaashan bukaan oo aan waligood helin daawaynta ku-tilmaanta BCMA ka hor laakiin lahaa ugu yaraan afar khad oo hore oo daawaynta-proteasome inhibitor ah, daawada immunomodulatory, iyo anti-CD38 monoclonal antibody-ayaa ka dhigay dadka waxtarka leh ee aasaasiga ah. Sagaashan iyo toddoba bukaan (95% CI: 47.3%, 67.7%) qiyaasta lagu taliyey waxay lahaayeen ORR ee 57.7%. Dhexdhexaadka DOR ee jawaabeyaasha lama gaadhin ka dib dabagal 11.1 bilood ah (95% CI: 12 bilood, lama gaadhin). 90.4% (95% CI: 78.4%, 95.9%) waxay ahayd heerka DOR lix bilood, iyo 82.3% (95% CI: 67.1%, 90.9%) sagaal bilood.
Macluumaadka qorida Elranatamab-bcmm waxaa ka mid ah Digniinta Sanduuqa ah ee dhaawaca neerfaha, oo ay ku jiraan saameynta difaaca jirka ee la xiriirta neurotoxicity (ICANS), iyo cytokine sii daayo syndrome (CRS), kaas oo noqon kara dilaa ama nafta halis gelin kara. Elranatamab-bcmm waxaa la siiyay bukaanada qiyaasta loo qoray; iyaga ka mid ah, 58% waxay la kulmeen CRS, 59% waxay la kulmeen dhaawac neerfaha, iyo 3.3% ICANS khibrad u leh. 0.5% shakhsiyaadka, fasalka 3 CRS ayaa dhacay, halka 7% kiisaska, fasalka 3 ama 4 sunta neerfaha ay dhaceen. Elranatamab-bcmm waxa kaliya oo lagu heli karaa barnaamijka xaddidan ee hoos yimaada Istaraatiijiyada Qiimaynta Khatarta iyo Yaraynta (REMS), oo loo yaqaan ELREXFIO REMS, iyadoo ay ugu wacan tahay khatarta CRS iyo sunta neerfaha, oo ay ku jiraan ICANS.
CRS, daal, jawaabta goobta la duray, shuban, caabuqa neef-mareenka sare, raaxo la'aanta murqaha, oof-wareen, rabitaanka cuntada oo yaraada, finan, qufac, lallabbo, iyo pyrexia ayaa ahaa waxyeellooyinka soo noqnoqda (≥20%). Hoos u dhaca haemoglobin, neutrophils, platelets, lymphocytes, iyo unugyada dhiiga cad ayaa ah kuwa ugu badan ee aan caadi ahayn ee shaybaadhka 3 ilaa 4 (≥20%).
Qiyaasta daawaynta ugu horreysa ee 76 mg maalinta 8 waxaa raacaya "dose kor u qaadista 1" ee 12 mg maalinta 1 iyo "kor u qaadida qiyaasta 2" ee 32 mg maalinta 4. Qiyaasaha elranatamab-bcmm ee lagu taliyey waa sida soo socota. : 76 mg asbuuc kasta illaa Usbuuca 24. Muddada qiyaasta qiyaasta waa in loo beddelaa labadii toddobaadba mar bukaannada qaatay elranatamab-bcmm ugu yaraan toddobaadyada 24, muujiyay jawaabaha qayb ahaan, ama ka wanaagsan, iyo jawaabaha joogtada ah ugu yaraan laba bilood. Elranatamab-bcmm waa la qaadan karaa ilaa uu cudurku ka sii darayo ama heerka suntu ay noqoto mid aan loo dulqaadan karin.
