NgoMashi 31, 2025, i-Innovent Biologics yamemezela ukuthi i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina inikeze i-Breakthrough Therapy Designation (BTD) ye-IBI363, iphrotheni yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein, njengokwelashwa okukodwa kokwelapha i-melanoma engasuswa endaweni noma esakazekile noma esakazekile engakaze ithole ukwelashwa kwesistimu ngaphambilini.
Mayelana ne-IBI363 (Iphrotheni yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein)
I-IBI363 iyisidakamizwa sokuqala esikhiqizwe ngokuzimela yi-Innovent Biologics. Iyiprotheni ye-PD-1/IL-2 bispecific antibody fusion eyenzelwe ukuthuthukisa ukusebenza kahle ngenkathi inciphisa ubuthi. Ingalo ye-IL-2 ye-IBI363 yenzelwe ukwenza ngcono imiphumela yokwelapha ngemiphumela emibi encishisiwe, kuyilapho ingalo yokubopha ye-PD-1 ivumela ukuvimba kwe-PD-1 kanye nokulethwa kwe-IL-2 okukhethiwe. Ngokuvimbela ngasikhathi sinye indlela ye-PD-1/PD-L1 kanye nokusebenzisa indlela ye-IL-2, i-IBI363 yenza kube lula ukuqondiswa kanye nokusebenza kwamaseli e-T athile ane-tumor. Izifundo zangaphambi kokwelashwa zibonise ukuthi i-IBI363 ibonisa umsebenzi oqinile wokulwa ne-tumor kumamodeli amaningi e-pharmacological aphethe i-tumor, kufaka phakathi lawo amelana nama-PD-1 inhibitors namamodeli e-metastatic. Ngaphezu kwalokho, ibonise iphrofayili yokuphepha enhle kumamodeli angaphambi kokwelashwa.
Izivivinyo zemitholampilo ze-IBI363 ziyaqhubeka eShayina, e-United States, nase-Australia ukuhlola ukuphepha kwayo, ukubekezeleleka kwayo kanye nokusebenza kwayo kokuqala kubantu abanezifo zomdlavuza ezithuthukile. Ucwaningo lokuqala olubalulekile lwe-IBI363 seluqalisiwe, lokwelapha i-IO-naive mucosal noma i-acral melanoma.
Ngaphezu kwalokho, i-IBI363 ithole izikhundla ezimbili ze-fast track (FTD) ezivela ku-US FDA, zokwelapha i-melanoma kanye ne-squamous NSCLC, ngokulandelana. I-IBI363 iphinde yathola izikhundla ze-throughth therapy ezivela ku-NMPA yaseShayina zokwelapha i-melanoma.
I-Innovent Yethula Idatha Yezokwelapha Yesigaba 1 se-First-in-class PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) ku-Melanoma eMhlanganweni Waminyaka Yonke we-ASCO ka-2024.
Abantu abangu-67 abane-melanoma ethuthukisiwe noma esakazekile endaweni abahlulekile noma abangabekezeleli ukwelashwa okujwayelekile babhaliswa futhi bathola i-IBI363 ngemithambo yegazi emazingeni omthamo aphakathi kuka-100 μg/kg QW kanye no-2 mg/kg Q3W. Abantu abangu-89.6% basebethole ukwelashwa nge-immunotherapy ngaphambilini, kanti abangu-61.2% basebethole imigqa engu-≥ emibili yokwelashwa ngesistimu ngaphambilini. Abantu abangu-25.4% basebethole ukwelashwa ngesibindi okuyisisekelo kanti abangu-70.1% basebethole ukwelashwa nge-acral noma nge-mucosal subtypes.
Kusukela ngoJanuwari 11, 2024, abantu abangu-57 babene okungenani ukuhlolwa kwesimila oku-1 ngemuva kokuqala. Impendulo engcono kakhulu iyonke kwaba impendulo ephelele (CR) kumuntu oyedwa, impendulo engaphelele (PR) kubantu abangu-15 ngokulandelana. Izinga lokuphendula lilonke (ORR) lalingu-28.1% (95%CI: 17.0-41.5) kanti i-DCR yayingu-71.9% (95%CI: 58.5-83.0). Kubantu abangu-25 abelashwe nge-immunotherapy (IO) eqenjini le-1mg/kg le-Q2W dose (n=25), i-ORR yayingu-32.0% (95%CI: 14.9-53.5), i-DCR yayingu-80.0% (95%CI: 59.3-93.2).
Ngokuphathelene nokuphepha, abantu abangu-16 (23.9%) babenemiphumela emibi ephuthumayo yokwelashwa kwebanga ≥3 (ama-TEAE). Ama-TEAE avame kakhulu kwakuyi-arthralgia (34.3%), i-hyperthyroidism (29.9%), kanye ne-anemia (25.4%). Imicimbi emibi ehlobene nokuzivikela komzimba yebanga ≥3 (ama-irAE) yenzeka kubantu abangu-8 (11.9%). Akukho TRAE eholele ekufeni eyenzekile.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Ephreli-01-2025