Ku ya 31 Werurwe 2025, Innovent Biologics yatangaje ko Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemereye Breakthrough Therapy Designation (BTD) Ibi363, poroteyine ya mbere mu cyiciro cya PD-1/IL-2α-bias bispecific antibody fusion protein, nk'uburyo bwo kuvura melanoma idakira cyangwa yanduye mu gace runaka cyangwa itarakira abantu batarigeze bahabwa ubuvuzi bw’umubiri mbere.
Ibijyanye na IBI363 (Poroteyine ya mbere mu cyiciro cya PD-1/IL-2α-bias bispecific antibody fusion)
IBI363 ni umuti wa mbere mu rwego rwo hejuru wakozwe ku giti cya Innovent Biologics. Ni poroteyine ya PD-1/IL-2 bispecific antibody fusion yagenewe kongera imikorere mu gihe igabanye uburozi. IL-2 arm ya IBI363 yakozwe kugira ngo yongere ingaruka nziza ku buvuzi hamwe n’ingaruka mbi nke, mu gihe PD-1 binding arm ituma PD-1 blockade no gutanga IL-2. Mu guhagarika icyarimwe inzira ya PD-1/PD-L1 no gukora inzira ya IL-2, IBI363 yorohereza kwibanda no gukora neza uturemangingo twa T twihariye. Ubushakashatsi bwakozwe mbere y’ibizamini bwagaragaje ko IBI363 igaragaza imikorere ikomeye yo kurwanya ikibyimba mu buryo bwinshi bw’imiti bufite kanseri, harimo n’izidakoresha PD-1 inhibitors na metastatic models. Byongeye kandi, yagaragaje umutekano mwiza mu buryo bw’ibizamini mbere y’ibizamini.
Igeragezwa rya IBI363 ririmo gukorwa mu Bushinwa, muri Leta Zunze Ubumwe za Amerika na Ositaraliya kugira ngo harebwe umutekano wayo, ubushobozi bwo kwihanganira kanseri ndetse n'ubushobozi bwayo ku barwayi bafite kanseri ikomeye. Inyigo ya mbere y'ingenzi kuri IBI363 yaratangijwe, kugira ngo ivurwe indwara ya IO-naive mucosal cyangwa acral melanoma.
Byongeye kandi, IBI363 yahawe impamyabumenyi ebyiri zihuse (FTD) zitangwa na FDA yo muri Amerika, mu kuvura melanoma na squamous NSCLC, uko bikurikirana. IBI363 yahawe kandi impamyabumenyi y’ubuvuzi bugezweho itangwa na NMPA yo mu Bushinwa mu kuvura melanoma.
Innovent Igaragaza Amakuru y’icyiciro cya mbere cy’ubuvuzi bwa PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) muri Melanoma mu nama ngarukamwaka ya ASCO yo mu 2024.
Abantu 67 bafite melanoma yateye imbere cyangwa yanduye mu gace runaka ariko bananiwe cyangwa batihanganira ubuvuzi busanzwe bashyizwe mu byiciro kandi bahabwa IBI363 mu mitsi ku gipimo kiri hagati ya 100 μg/kg QW na 2 mg/kg Q3W. 89.6% by'abarwayi bari barahawe ubuvuzi bw'imyororokere mbere, naho 61.2% by'abarwayi bari bafite imirongo ≥ ibiri yakoreshejwe mbere yo kuvurwa ku mubiri. 25.4% by'abarwayi bari bafite umwijima wanduye mbere naho 70.1% by'abarwayi bari bafite ubwoko bwa acral cyangwa mucosal.
Kugeza ku ya 11 Mutarama 2024, abantu 57 bakoze nibura isuzuma rya nyuma y’ibiza. Igisubizo cyiza muri rusange cyari igisubizo cyuzuye (CR) ku muntu umwe, igisubizo cy’igice (PR) ku bantu 15 uko bikurikirana. Igipimo rusange cy’ibiza (ORR) cyari 28.1% (95%CI: 17.0-41.5) naho DCR ikaba 71.9% (95%CI: 58.5-83.0). Mu bantu 25 bavuwe na immunotherapy (IO) mu itsinda rya 1mg/kg Q2W dose (n=25), ORR yari 32.0% (95%CI: 14.9-53.5), DCR yari 80.0% (95%CI: 59.3-93.2).
Ku bijyanye n'umutekano, abantu 16 (23.9%) bari bafite ibyago byihutirwa byo kuvurwa (TEAEs) ku rwego rwa ≥3. Indwara za TEAE zikunze kugaragara ni arthralgia (34.3%), hyperthyroidism (29.9%), na anemia (25.4%). Indwara za ≥3 ziterwa n'ubudahangarwa bw'umubiri (irAEs) zabaye ku bantu 8 (11.9%). Nta TRAE yahitanye abantu.
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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Igihe cyo kohereza: Mata-01-2025