Mashi 2024: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) kuhlanganiswe ne-obinutuzumab inikezwe imvume esheshisiwe yi-Food and Drug Administration yokwelashwa kwe-lymphoma ephindaphindayo noma e-refractory follicular lymphoma (FL) ezigulini ezibe nemigqa emibili noma ngaphezulu yokwelapha okuhlelekile.
Ukusebenza komuthi kwahlolwa ku-Study BGB-3111-212 (ROSEWOOD; NCT03332017), okwakuyisivivinyo somtholampilo esihlanganisa iziguli zabantu abadala ezingama-217 ezine-lymphoma ephindaphindekayo noma e-refractory follicular lymphoma (FL) ezazithole okungenani izindlela zokwelapha ezi-2 zangaphambilini zesistimu. Ukuhlolwa kwenziwe ezikhungweni eziningi futhi bekunelebula evulekile futhi kwenziwa ngokungahleliwe. Iziguli zabelwa ngokungahleliwe ngesilinganiso esingu-2:1 ukuze zithole noma i-zanubrutinib ngethamo lika-160 mg ngomlomo kabili ngosuku kuze kube yilapho isifo siqhubeka noma kukhona ubuthi obungamukeleki, kuhlangene ne-obinutuzumab (ZO), noma ukuthola i-obinutuzumab iyodwa. Inombolo emaphakathi yemizamo yokwelashwa yangaphambilini yayingu-3, nebanga elisuka ku-2 kuye ku-11.
Ukuphumelela kokwelashwa kwahlolwa ikomidi lokubuyekeza elizimele, ngokusekelwe kusilinganiso sokuphendula jikelele (ORR) kanye nesikhathi sokuphendula (DOR). Isilinganiso sokuphendula sisonke (ORR) sasingu-69% (95% isikhawu sokuzithemba [CI]: 61, 76) engalweni ye-ZO kanye no-46% (95% CI: 34, 58) engalweni ye-obinutuzumab (inani le-p elinezinhlangothi ezimbili , 0.0012). Ngemuva kwezinyanga ze-19.0 zokubhekwa, ubude besikhathi sokuphendula (DOR) abunqunywanga engalweni ye-ZO (95% CI: izinyanga ze-25.3, NE), kuyilapho kuyizinyanga ze-14.0 (95% CI: 9.2, 25.1) ezigulini ezitholile. i-obinutuzumab monotherapy. Engalweni ye-ZO, isilinganiso esilinganisiwe sempendulo yenhloso eqinile (DOR) ezinyangeni ezingu-18 sasingu-69% nesikhawu sokuzethemba esingu-95% (CI) sika-58% kuya ku-78%.
Ocwaningweni lwemitholampilo lwezanubrutinib, imiphumela emibi evame ukubonwa (eyenzeka okungenani ku-30% wamacala), ehlanganisa nemiphumela yaselabhorethri engajwayelekile, kube amazinga ancishisiwe we-neutrophils (51%) nama-platelet (41%), izifo zepheshana lokuphefumula eliphezulu. (38%), ukopha (32%), nokungakhululeki kwemisipha namathambo (31%). I-ZO ibangele imiphumela emibi kakhulu ku-35% weziguli ezine-FL.
Umthamo ophakanyisiwe we-zanubrutinib ngu-160 mg othathwa ngomlomo kabili ngosuku noma u-320 mg ngomlomo kanye ngosuku ngaphandle uma kukhona ukuqhubeka kwesifo noma ubuthi obungabekezeleleki.
