Pa February 17, 2025, Innovent Biologics yalengeza kuti puloteni yake yoyamba ya PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, yalandira Fast Track Designation yake yachiwiri (FTD) kuchokera ku US Food and Drug Administration (FDA). Izi zikugwira ntchito pochiza khansa ya m'mapapo ya squamous non-small cell (sqNSCLC) yosachiritsika, yopita patsogolo, kapena yofalikira kwambiri yomwe yapita patsogolo pambuyo pa chithandizo cha anti-PD-(L)1 immune checkpoint inhibitor ndi platinum-based chemotherapy. IBI363 yawonetsa kuti ikugwira ntchito bwino komanso chitetezo pamitundu yambiri ya khansa yolimba. Pakadali pano, Innovent ikuchita mayeso azachipatala a Gawo 1/2 a IBI363 makamaka ku China ndi US.
Kusankhidwa kwa Fast Track (FTD) ndi njira yoyendetsera ntchito yopangidwira kufulumizitsa chitukuko cha zachipatala ndikuwunikanso mankhwala omwe cholinga chake ndi kuchiza matenda akuluakulu ndikuthana ndi zosowa zachipatala zomwe sizinakwaniritsidwe. Anthu omwe akufuna mankhwala omwe amapatsidwa mwayi wa FTD amapindula ndi kulumikizana kwakukulu ndi FDA panthawi yonse yopanga mankhwala, zomwe zingafulumizitse chitukuko chawo chachipatala ndi njira yovomerezeka.
Zokhudza IBI363 (Puloteni yoyamba ya PD-1/IL-2α-bias bispecific antibody fusion protein))
IBI363 ndi mankhwala oyamba omwe amapangidwa paokha ndi Innovent Biologics. Ndi puloteni ya PD-1/IL-2 bispecific antibody fusion yopangidwa kuti iwonjezere magwiridwe antchito pomwe ikuchepetsa poizoni. IL-2 arm ya IBI363 yapangidwa kuti iwonjezere zotsatira zochizira ndi zotsatirapo zochepa, pomwe PD-1 binding arm imalola PD-1 blockade ndi kusankha IL-2. Mwa kuletsa nthawi yomweyo njira ya PD-1/PD-L1 ndikuyambitsa njira ya IL-2, IBI363 imathandizira kuyang'ana molondola komanso moyenera maselo a T enieni a chotupa. Kafukufuku woyambirira wasonyeza kuti IBI363 ikuwonetsa mphamvu yolimbana ndi chotupa m'mitundu yambiri yamankhwala yokhala ndi chotupa, kuphatikiza omwe amalimbana ndi zoletsa za PD-1 ndi mitundu yofalikira. Kuphatikiza apo, yawonetsa mbiri yabwino yachitetezo m'mitundu yoyambirira. Mayeso azachipatala akuchitika ku China, United States, ndi Australia kuti awone chitetezo chake, kulekerera komanso kugwira ntchito koyambirira kwa anthu omwe ali ndi khansa yapamwamba.
Pa Msonkhano Wapadziko Lonse Wokhudza Khansa ya M'mapapo (WCLC) mu Seputembala 2024, IBI363 idapereka zizindikiro zodalirika zogwira ntchito bwino kwa odwala omwe ali ndi sqNSCLC omwe adalandira kale chithandizo cha immunotherapy:
Mu gulu la 3 mg/kg la mlingo, pakati pa odwala omwe adatenga milungu 12 yotsatiridwa kapena kumaliza maphunziro (n=18), chiŵerengero cha yankho lolunjika (ORR) chinali 50.0%, ndipo chiŵerengero cha kulamulira matenda (DCR) chinali 88.9%. Kupulumuka kwapakati kosapitirira muyeso (PFS) sikunafikebe ndipo kukupitirirabe kutsatiridwa.
Mu gulu la 1/1.5 mg/kg la mlingo, PFS yapakati inali miyezi 5.5 (95% CI: 1.5, 8.3), ndi chiŵerengero cha PFS cha miyezi 12 cha 30.7%, zomwe zikusonyeza ubwino wa nthawi yayitali wa chithandizo cha immunotherapy.
M'magulu onse a 1/1.5/3 mg/kg omwe anali ndi mlingo, odwala omwe ali ndi PD-L1 TPS <1% (n=22) ndi omwe ali ndi PD-L1 TPS≥1% (n=22) adapeza ma ORR olimbikitsa a 36.4% ndi 31.8%, motsatana, zomwe zikusonyeza kuti IBI363 ikhoza kukhala ndi ubwino pa anthu omwe PD-L1 salankhula bwino.
Zokhudza Khansa ya M'mapapo ya Squamous Non-Small Cell (sqNSCLC)
Khansa ya m'mapapo ndi khansa yofala kwambiri komanso yoopsa kwambiri padziko lonse lapansi, kuphatikizapo ku China [1], zomwe zimapangitsa kuti pakhale vuto lalikulu paumoyo wa anthu. Khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC) imakhudza anthu oposa 80% ya milandu yonse ya khansa ya m'mapapo [2], ndipo khansa ya squamous cell ndi imodzi mwa mitundu iwiri ikuluikulu [2]. M'zaka zaposachedwa, zoletsa chitetezo chamthupi zasintha malo ochizira a NSCLC. Komabe, kwa odwala omwe ali ndi NSCLC omwe alephera chithandizo cha immunotherapy ndipo alibe kusintha kwa majini, pakadali kufunikira kwakukulu komanso kofulumira kwa njira zochizira zogwira mtima. Chithandizo chachiwiri kapena chachitatu, docetaxel, chimapereka mphamvu zochepa, ndi moyo wopanda kupitirira (PFS) wapakati pa miyezi inayi [3], [4]. Ngakhale kuti ma conjugates a antibody-drug (ADCs) awonetsa kuti ndi abwino, maphunziro awiri akuluakulu a Gawo 3 mu NSCLC ya squamous sanawonetsebe mphamvu yogwira ntchito.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Feb-20-2025