Musi wa31 Kurume, 2025, Innovent Biologics yakazivisa kuti Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yeChina yakapa Breakthrough Therapy Designation (BTD) yeIBI363, protein yekutanga mukirasi yePD-1/IL-2α-bias bispecific antibody fusion, senzira yekurapa melanoma isina kubviswa mumuviri kana metastatic mucosal kana acral isina kurapwa.
Nezve IBI363 (Physical-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)
IBI363 mushonga wekutanga mukirasi yakagadzirwa yakazvimirira neInnovent Biologics. Iprotein yePD-1/IL-2 bispecific antibody fusion yakagadzirirwa kuwedzera kushanda zvakanaka uku ichideredza chepfu. IL-2 arm yeIBI363 yakagadzirwa kuti ivandudze mhedzisiro yekurapa nekuderedza mhedzisiro, ukuwo PD-1 binding arm ichigonesa PD-1 blockade uye selective IL-2 delivery. Nekudzivisa PD-1/PD-L1 pathway uye kuvhura IL-2 pathway, IBI363 inobatsira kutarisa uye kushanda kwemasero eT chaiwo ane bundu. Zvidzidzo zve preclinical zvakaratidza kuti IBI363 inoratidza kushanda kwakasimba kwekurwisa bundu mumamodheru akawanda ane bundu, kusanganisira ayo anodzivirira PD-1 inhibitors nemamodheru ane metastatic. Pamusoro pezvo, yakaratidza kuchengetedzeka kwakanaka mumamodheru e preclinical.
Miedzo yekiriniki yeIBI363 iri kuitwa muChina, United States, neAustralia kuti vaongorore kuchengetedzeka kwayo, kushivirira kwayo uye kushanda kwayo kwekutanga kune vanhu vane kenza yakanyanya kukura. Chidzidzo chekutanga chakakosha cheIBI363 chakatangwa, chekurapa IO-naive mucosal kana acral melanoma.
Uyezve, IBI363 yakagamuchira zvitupa zviviri zvekukurumidza (FTD) kubva kuUS FDA, zvekurapa melanoma nesquamous NSCLC, zvichiteerana. IBI363 yakagamuchirawo zvitupa zvekubudirira kubva kuNMPA yekuChina zvekurapa melanoma.
Innovent Inopa Ruzivo rwekiriniki rwechikamu chekutanga chePD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) muMelanoma paMusangano weGore weASCO wa2024.
Vanhu 67 vane melanoma yakakwira kana kuti yakapararira munzvimbo iyoyo vakatadza kana kuti vasingashiviriri kurapwa kwakajairika vakanyoreswa uye vakapihwa IBI363 netsinga padanho repakati pe100 μg/kg QW uye 2 mg/kg Q3W. 89.6% yevanhu vakamborapwa nedziviriro yemuviri kare, uye 61.2% yevanhu vakamborapwa netsinga dzemuviri kare vakamborapwa netsinga dzemuviri kanopfuura kaviri. 25.4% yevanhu vakamborapwa netsinga dzechiropa uye 70.1% yevanhu vakamborapwa netsinga dzemudumbu kana dzemudumbu.
Kubva musi wa11 Ndira, 2024, vanhu 57 vakaongororwa bundu kamwe chete mushure mekutanga. Mhinduro yakanakisisa yaive mhinduro yakakwana (CR) mumunhu mumwe chete, mhinduro isina chikamu (PR) muvanhu 15 zvichiteerana. Mwero wemhinduro yose (ORR) waive 28.1% (95%CI: 17.0-41.5) uye DCR yaive 71.9% (95%CI: 58.5-83.0). Muvanhu 25 vakarapwa neimmunotherapy (IO) muboka re1mg/kg reQ2W dose (n=25), ORR yaive 32.0% (95%CI: 14.9-53.5), DCR yaive 80.0% (95%CI: 59.3-93.2).
Nezvekuchengetedzwa, vanhu 16 (23.9%) vaive nezviitiko zvinokuvadza zvekurapa zvegiredhi ≥3 (TEAEs). Zvinowanzoitika zveTEAE zvaive arthralgia (34.3%), hyperthyroidism (29.9%), uye anemia (25.4%). Zviitiko zvinokuvadza zvine chekuita neimmune system (irAEs) zvegiredhi ≥3 zvakaitika muvanhu 8 (11.9%). Hapana TRAE yakakonzera rufu yakaitika.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Nguva yekutumira: Kubvumbi-01-2025