Innovent yahawe umwanya wa kabiri wihuse na FDA yo muri Amerika kuri IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) muri Kanseri y'ibihaha ya Squamous Non-Small Cell

Ku ya 17 Gashyantare 2025, Innovent Biologics yatangaje ko poroteyine yayo ya mbere mu cyiciro cya PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, yahawe inyito yayo ya kabiri ya Fast Track (FTD) itangwa n'Ikigo gishinzwe ibiribwa n'imiti muri Amerika (FDA). Iyi nyito ikoreshwa mu kuvura kanseri y'ibihaha idakira, iteye imbere mu gace runaka, cyangwa iterwa n'uturemangingo duto tw'ibihaha (sqNSCLC) yateye imbere nyuma yo kuvura kanseri igabanya ubukana bw'umubiri (PD-(L)1) hamwe n'imiti ikoreshwa muri platine. IBI363 yagaragaje ko itera imbaraga n'umutekano mu bwoko bwinshi bw'ibibyimba bikomeye. Ubu, Innovent irimo gukora igerageza rya IBI363 mu cyiciro cya 1/2 cyane cyane mu Bushinwa no muri Amerika.

Guhitamo vuba (FTD) ni inzira y’amategeko igamije kwihutisha iterambere ry’ubuvuzi no gusuzuma imiti igamije kuvura indwara zikomeye no gukemura ibibazo by’ubuvuzi bitaragerwaho. Abashaka imiti bahabwa inyungu za FTD mu gutumanaho na FDA mu gihe cyose cyo gutegura imiti, bishobora kwihutisha iterambere ryabo ry’ubuvuzi no kwemezwa.

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’ibiza bwagaragaje ko IBI363 igaragaza imikorere ikomeye yo kurwanya ikibyimba mu buryo bwinshi bw’imiti bufite kanseri, harimo n’izidafata imiti ya PD-1 n’uburyo bwa metastatic. Byongeye kandi, yagaragaje umutekano mwiza mu buryo bwa mbere y’ibiza. Igerageza ry’ubuvuzi ririmo gukorwa mu Bushinwa, muri Leta Zunze Ubumwe za Amerika, na Ositaraliya kugira ngo risuzume umutekano waryo, kwihanganira no gukora neza kw’ibanze ku bantu bafite kanseri ikomeye.

Mu nama y’Isi ku Kanseri y’Ibihaha (WCLC) yabaye muri Nzeri 2024, IBI363 yagaragaje ibimenyetso bitanga icyizere ku barwayi bafite sqNSCLC bari barahawe imiti ivura ubudahangarwa bw’umubiri mbere:

Mu itsinda rya 3 mg/kg, mu barwayi bamaze nibura ibyumweru 12 bakurikiranwa cyangwa barangije inyigo (n=18), igipimo cy’ingaruka zifatika (ORR) cyari 50.0%, naho igipimo cyo kurwanya indwara (DCR) cyari 88.9%. Igipimo cy’ubuzima buzira umuze (PFS) ntikiragerwaho kandi kiracyakurikiranwa.

Mu itsinda rya 1/1.5 mg/kg, impuzandengo ya PFS yari amezi 5.5 (95% CI: 1.5, 8.3), aho igipimo cya PFS cy'amezi 12 cya 30.7%, bigaragaza ibyiza by'igihe kirekire byo kuvura ubudahangarwa bw'umubiri.

Mu matsinda y’ibipimo bya 1/1.5/3 mg/kg, abarwayi bafite PD-L1 TPS<1% (n=22) n’abafite PD-L1 TPS≥1% (n=22) bageze ku rugero rwa ORRs rungana na 36.4% na 31.8%, uko bikurikirana, bigaragaza ko IBI363 ishobora kugira akamaro mu bantu bafite PD-L1 idakoresha uburyo bwinshi bwo kuvuga.

Ku bijyanye na Kanseri y'ibihaha idafite utunyangingo duto (sqNSCLC)

Kanseri y'ibihaha ni yo kanseri ikunze kugaragara cyane kandi yica cyane ku isi, harimo no mu Bushinwa [1], ikaba itera ikibazo gikomeye ku buzima rusange. Kanseri y'ibihaha itari iy'uturemangingo duto (NSCLC) ifata abarenga 80% by'abarwayi bose ba kanseri y'ibihaha [2], aho kanseri y'uturemangingo duto ari imwe mu ndwara ebyiri zikomeye [2]. Mu myaka ya vuba aha, imiti igabanya ubudahangarwa bw'umubiri yahinduye uburyo bwo kuvura NSCLC. Ariko, ku barwayi ba NSCLC bananiwe kuvura ubudahangarwa bw'umubiri kandi badafite impinduka mu miterere y'uturemangingo, haracyakenewe uburyo bufatika kandi bwihutirwa bwo kuvura neza. Ubuvuzi busanzwe bwa docetaxel, butanga umusaruro muke, aho ubutabazi bw'ibanze butagira ingaruka ku iterambere (PFS) butarenze amezi ane [3], [4]. Nubwo imiti igabanya ubudahangarwa bw'umubiri (ADCs) yagaragaje ko ari byiza, inyigo ebyiri nini zo mu cyiciro cya 3 muri NSCLC y'uturemangingo duto ntiziragaragaza ko zikora neza.

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.Innovent (innoventbio.com)

2.MA11.04 Antibody ya mbere mu cyiciro cya PD-1/IL-2 Ibice bibiri IBI363 ku barwayi ba kanseri y'ibihaha itari iy'uturemangingo duto mu cyiciro cya mbere cy'ubushakashatsi – ScienceDirect