IBI343 (CLDN 18.2 ADC) yashyizwe mu rwego rw’umuti w’ingirakamaro uvura indwara ziterwa n’ibiyobyabwenge mu rwego rw’igihugu mu kuvura abarwayi ba kanseri y’udukoko twa pancreas.

Ku ya 8 Mutarama, Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyahaye icyitegererezo cya Breakthrough Therapy (BTD) cya IBI343, umuti ushobora kuba mwiza cyane wo kurwanya CLDN18.2 ADC, nk'umuti umwe wo kuvura abarwayi ba CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) bamaze gutera imbere nyuma y’uburyo bumwe bwo kuvurwa mbere.

BTD ya IBI343 yatanzwe hashingiwe ku makuru yavuye mu bushakashatsi bwakozwe mu cyiciro cya mbere mu Bushinwa, Ositaraliya na Amerika (NCT05458219), bwagaragaje umutekano mwiza no kwihanganira, ndetse n'imikorere myiza yo kurwanya kanseri ya IBI343 ku barwayi ba PDAC bateye imbere. Amakuru yavuye mu itsinda ry’ubushakashatsi ryo kwagura igipimo yatanzwe mu magambo mu nama ya ESMO Asia ya 2024:

Kugeza ku ya 6 Nzeri 2024, abarwayi 43 bose hamwe bafite CLDN18.2-positive (≥60% by tumors tumors with membranous impact ≥1+ by IHC) PDAC yateye imbere bahawe IBI343 6 mg/kg Q3W monotherapy. Abitabiriye bose bari bamaze guhabwa nibura umurongo umwe w’ubuvuzi mbere, naho 60.5% bari barahawe imirongo ibiri cyangwa irenga y’ubuvuzi bwo kurwanya kanseri.

Abarwayi 43 bapimwe ubushobozi bwabo, aho igipimo rusange cy’ubutabazi bw’ibanze (ORR) cya 32.6%, igipimo cy’ubutabazi bw’ibanze (cORR) cya 23.3%, n’igipimo cy’ubutabazi bw’ibanze (cDCR) cya 81.4%.

Ubwo amakuru yatangwaga, abarwayi 4 kuri 10 ba cORR bari bamaze gutera imbere, igihe cyo hagati cyo gusubiza (mDoR) cyari amezi 7.0 (4.0-NC), naho igipimo cya DoR cy'amezi 6 cyari 63%. Abarwayi 26 bahuye n'ibibazo bya PFS, aho hagati yo kubaho nta ntambwe yo gutera imbere (mPFS) ari amezi 5.3 (4.1-7.4), kandi amakuru ya OS ntaragera ku rwego rwo hejuru.

Ibisubizo by’umutekano bivuguruye byagaragaje umutekano mwiza wa IBI343 hamwe n’igipimo gito cy’uburozi mu gifu kandi nta bimenyetso bishya by’umutekano byagaragaye. 97.7% by’abitabiriye bahuye n’ingaruka mbi zo kuvurwa (TEAEs), aho TEAE zikunze kugaragara cyane ari ukubura amaraso, umubare wa neutrophil waragabanutse, kugabanuka k’ubushake bwo kurya, isesemi, n’umubare w’uturemangingo tw’amaraso tw’umweru waragabanutse. 51.2% by’abitabiriye bahuye n’ibipimo bya TEAE by’icyiciro cya 3, kandi nta isesemi cyangwa kuruka by’icyiciro cya 3 byabayeho. Nta TEAE yateje urupfu.

Ku bijyanye na IBI343 (Anti-CLDN18.2 ADC)

IBI343 ni umuti uhuza imiti irwanya CLDN18.2 monoclonal antibody-drug conjugate (ADC) wakozwe na Innovent Biologics. IBI343 ihuza n'uturemangingo twa kanseri dutanga CLDN18.2, ADC iterwa na CLDN18.2 iratangira gukoreshwa, umuti ukarekurwa bigatera kwangirika kwa ADN ndetse amaherezo ukagira ingaruka ku turemangingo twa kanseri. Uwo muti urekuwe ushobora no gukwirakwira mu ruhu rw'amaraso kugira ngo ugere ku turemangingo twegeranye kandi wice, bigatera "ingaruka mbi zo kwica umuntu ureba kure".

Nk'umuti ugezweho wa TOPO1i ADC, IBI343 yagaragaje umutekano wihanganirwa kandi itera imbaraga ibimenyetso by'imikorere mu bushakashatsi bwakozwe mu cyiciro cya 1. Ubu hari ubushakashatsi ku bushobozi bwa IBI343 mu kuvura kanseri y'igifu n'iya pancreas.

Muri Gicurasi 2024, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyahaye IBI343 uburyo bwo kuvura indwara mu buryo bwihuse (BTD) kugira ngo ikoreshwe nk'umuti umwe ku barwayi ba CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma bahuye n’indwara nyuma y’uburyo bubiri bwo kuvurwa mbere. Igerageza rya Phase 3 (NCT06238843) rya IBI343 kuri iki kimenyetso rirakomeje.

Muri Kamena 2024, IBI343 yahawe icyemezo cya Fast Track na FDA (Ikigo cy’Ibiribwa n’Imiti cya Amerika) cyo kuvura indwara idasanzwe idakira cyangwa ikwirakwira mu mitsi ya pancreas (PDAC) yongeye kugaragara cyangwa/cyangwa idakira uburyo bumwe bwo kuvura mbere. Igerageza rya Icyiciro cya 1 mu turere twinshi (NCT05458219) rya IBI343 kuri PDAC yavuwe mbere rirakomeje.

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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Amareferensi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.innoventbio.com/#/

3.132MO Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 ku barwayi (pts) bafite adenocarcinoma ya pancreas ductal adenocarcinoma (PDAC) iteye imbere: Ibisubizo bivuguruye bivuye mu bushakashatsi bwa phase I - Annals of Oncology