July 2023: Food and Drug Administration yakapa kukurumidza kubvumidza epcoritamab-bysp (Epkinly, Genmab US, Inc.) kuti idzoke kana kuti refractory diffuse hombe B-cell lymphoma (DLBCL) isina kutaurwa neimwe nzira, kusanganisira DLBCL inobva indolent lymphoma, uye yepamusoro-giredhi B-cell lymphoma mushure memitsara miviri kana kupfuura yehurongwa hwekurapa.
Epcoritamab-bysp, bispecific CD20-directed CD3 T-cell engager, yakaedzwa muEPCORE NHL-1 (NCT03625037), yakazaruka-label, multi-cohort, multicenter, single-arm study nevarwere vane relapsed kana refractory B-cell lymphoma. Kubudirira kwehuwandu hwakagadzirwa nevarwere ve148 vane kudzoka zvakare kana kuti refractory DLBCL, isina kutsanangurwa neimwe nzira, kusanganisira DLBCL kubva kune indolent lymphoma uye yakakwirira-giredhi B-cell lymphoma, mushure memitsara miviri kana kupfuura ye systemic therapy, kusanganisira imwe chete anti-CD20 monoclonal antibody-containing therapy.
Komiti Yakazvimiririra Yekuongorora yakashandisa nzira yeLugano 2014 kuti ione huwandu hwekupindura kwese (ORR), iyo yaive chiyero chakakosha chekubudirira. Iyo ORR yaive 61% (95% CI: 53-69), uye 38% yevarwere vaive nemhinduro yakakwana. Nekutevera kwepakati kwemwedzi ye9.8 kune vanopindura, iyo yakatarwa yepakati nguva yekupindura (DOR) yaive 15.6 mwedzi (95% CI: 9.7, isina kusvika).
Ruzivo rwemishonga ine Bhokisi Yambiro pamusoro cytokine release syndrome (CRS), inogona kunge yakakomba kana kukuuraya, uye immune effector cell-associated neurotoxicity syndrome (ICANS), inogona zvakare kuve yakakomba kana kukuuraya. Pakati peyambiro uye zviyero, hutachiona uye cytopenias dzinotaurwa. 51% yevanhu 157 vane kudzokazve kana kuti refractory hombe B-sero lymphoma uyo akatora yaifungidzirwa dosi ye epcoritamab-bysp yaive neCRS, 6% yaive neICANS, uye 15% yaive nehutachiona hwakakomba. Chikamu che37% chevanhu vane CRS vaive Grade 1, 17% vaive Grade 2, 2.5% vaive Grade 3. 4.5% yezviitiko zveICANS vaive Grade 1, 1.3% vaive Grade 2, uye 0.6% vaive Grade 5.
Epcoritamab-bysp inofanira kupihwa chete nemushandi akadzidzira zvekurapa ane rubatsiro rwakakwana rwekurapa kubata nekuitika kwakakomba seCRS neICANS. Nekuda kwemukana weCRS neICANS, vanhu vanotora 48 mg paZuva 15 reCycle 1 vanofanirwa kugara muchipatara kwemaawa makumi maviri nemana.
Mhedzisiro yaiitika kazhinji kazhinji (inenge 20%) yaive CRS, kuneta, kurwadziwa kwetsandanyama nemajoini, maitiro panzvimbo yejekiseni, fivha, marwadzo emudumbu, kusvotwa, uye manyoka. Zvakanyanya kunetsa muGrade 3 kusvika 4 lab abnormalities (10%) yaive nhamba yakaderera yemalymphocytes, neutrophils, white blood cells, hemoglobin, uye maplatelet.
Chirongwa chekurapa chinokurudzirwa kupa epcoritamab-bysp pasi peganda mazuva makumi maviri nemasere ega ega kusvika chirwere chanyanya kuipa kana kuti mhedzisiro yanyanya kuipa. MuCycle 28, iyo inonzi inonzi 1 mg paZuva 0.16, 1 mg paZuva 0.80, uye 8 mg paMazuva 48 uye 15. Izvi zvinoteverwa nechiyero chakagadziriswa che 22 mg vhiki imwe neimwe yeCycles 48 kuburikidza ne2, imwe neimwe vhiki yeCycles 3 kuburikidza ne4, uyezve masvondo mana ose paZuva 9 rekufamba.
Wona ruzivo rwakazara rwekuraira kweEpkinly.
