CDE ya NMPA itanga igitekerezo cy’isuzuma ry’ibanze kuri BL-B01D1 mu ndwara ya kanseri yo mu nda isubira inyuma/iterwa n’imitsi nyuma yo kunanirwa kwa PD-1/PD-L1 na Chimotherapie

Ku ya 28 Kanama, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyatangaje ko umuti wa BL-B01D1 wo guterwa inshinge uteganijwe gushyirwa mu gikorwa cyo gusuzuma ibyihutirwa. Ugenewe abarwayi ba kanseri yo mu nda isubira cyangwa yanduye mbere yo kuvurwa na antibodies za PD-1/PD-L1 monoclonal kandi bakaba barananiwe nibura imirongo ibiri ya chimiotherapie (harimo nibura umurongo umwe urimo platine).

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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iza-bren ni ADC ya mbere mu cyiciro igizwe na antibody ya EGFR x HER3 bispecific ihujwe na topo-I inhibitor payload nshya (Ed-04) binyuze mu gice gihuza gishingiye kuri tetrapeptide. Uburyo bubiri bw'imikorere ya Iza-bren bubuza ibimenyetso bya EGFR na HER3 ku tunyangingo twa kanseri, bigabanya kwiyongera no kubaho kw'utunyangingo. Byongeye kandi, iyo antibody ikoreshejwe, payload ya iza-bren yo kuvura irarekurwa bigatera stress ya genotoxic itera urupfu rw'utunyangingo twa kanseri.

Ibisubizo bya BL-B01D1 ku barwayi barwaye kanseri y’ibihaha idakomeye cyangwa isanzwe (NSCLC) ifite impinduka mu buryo bw’uturemangingo (GA) hanze y’impinduka za EGFR za kera byagaragajwe mu nama ngarukamwaka ya 2025 y’Umuryango w’Abanyamerika wita ku ndwara za kanseri (ASCO).

Uburyo: Igice cya Ib cy'ubu bushakashatsi cyari gikubiyemo amatsinda yo kwagura, buri kimwe cyagenwe na GA yagenwe mbere, harimo EGFR exon 20 insertions, non-classical EGFR mutations, mutations muri HER2, ALK, ROS1, BRAF (V600E n'izindi), KRAS (G12C n'izindi), SMARCA4, MET (Exon 14), RET, na NTRK. Amasomo hamwe n'aba GA bateye imbere ku miti isanzwe (niba ihari) kandi nta miti irenze imwe ya chimiotherapie yanditswe mbere. iza-bren yatanzwe kuri 2.5 mg/kg D1D8 Q3W.

Ibisubizo: Ku ya 5 Ukuboza 2024, abantu 73 ba NSCLC bafite GA bashyizwe ku rutonde bari bariyandikishije. Abantu batanu bari bakiri ku miti, ariko ntibashyizwe mu isesengura kubera ko habayeho gukurikirana ku buryo budahagije nyuma yo gupimwa bwa mbere (reba imbonerahamwe iri hepfo). Muri abantu 7 bashyizwemo EGFR exon 20, 85.7% (6 kuri 7) babonye cPR. Muri abantu 8 bahuye na KRAS G12C mutations, 3 cPR na 1 PR itegereje kwemezwa ni byo byagaragaye. Hazagaragazwa imikorere y'amatsinda mato. Indwara z'amaraso zikunze kugaragara cyane (ingeri zose) ni ukubura amaraso (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), na neutropenia (72.6%); Indwara za TRAE zitari iz’amaraso zikunze kugaragara cyane ni asthenia (42.5%), isesemi (41.1%), stomatitis (37.0%), impiswi (32.9%), na alopecia (31.5%). Indwara za TRAE zo mu cyiciro cya 3 no hejuru yazo zari zisanzwe zivura amaraso, zashoboye kuvurwa neza hakoreshejwe uburyo busanzwe bwo gushyigikira harimo no kugabanya urugero rw’umuti, nk’uko byagaragajwe na TRAE byatumye igipimo cyo guhagarika ku kigero cya 2.7%. Umuntu umwe gusa wanduye G2 ILD niwe wagaragaye. Ikigaragara ni uko nta rupfu rufitanye isano na iza-bren rwagaragaye. Nta bimenyetso bishya by’umutekano byagaragaye.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

Nimero ya Terefone: 4008803716

Indangamuntu ya WeChat: 17801183037

Email：myimmnet@163.com