Ngomhla wama-31 kuMatshi 2025, i-Innovent Biologics yabhengeza ukuba iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) yaseTshayina linike iBreakthrough Therapy Designation (BTD) ye-IBI363, iprotheyini yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein, njenge-monotherapy yokunyanga i-melanoma engasuswayo ekwindawo okanye esasazekayo okanye engabonakaliyo engakhange ifumane unyango lwenkqubo yangaphambili.
Malunga ne-IBI363 (Iprotheyini yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein)
I-IBI363 liyeza eliphambili eliphuhliswe ngokuzimeleyo yi-Innovent Biologics. Liyiprotheyini ye-PD-1/IL-2 bispecific antibody fusion eyenzelwe ukuphucula ukusebenza kakuhle ngelixa inciphisa ubuthi. Ingalo ye-IL-2 ye-IBI363 yenzelwe ukuphucula iziphumo zonyango ngeziphumo ebezingalindelekanga ezincitshisiweyo, ngelixa ingalo yokubopha ye-PD-1 ivumela i-PD-1 blockade kunye nokuhanjiswa kwe-IL-2 ekhethiweyo. Ngokuthintela ngaxeshanye indlela ye-PD-1/PD-L1 kunye nokusebenzisa indlela ye-IL-2, i-IBI363 yenza kube lula ukujolisa ngokuchanekileyo nangokufanelekileyo kunye nokusebenza kweeseli ze-T ezithile ze-tumor. Izifundo zangaphambi kweklinikhi zibonise ukuba i-IBI363 ibonisa umsebenzi onamandla wokulwa ne-tumor kwiimodeli ezininzi ze-pharmacological ezine-tumor, kubandakanya ezo zichasene ne-PD-1 inhibitors kunye neemodeli ze-metastatic. Ukongeza, ibonakalise iprofayili yokhuseleko efanelekileyo kwiimodeli zangaphambi kweklinikhi.
Uvavanyo lwezonyango lwe-IBI363 luyaqhubeka eTshayina, eMelika nase-Australia ukuvavanya ukhuseleko lwayo, ukunyamezeleka kwayo kunye nokusebenza kwayo kwangaphambili kubantu abaneengxaki zomhlaza eziphucukileyo. Uphononongo lokuqala olubalulekileyo lwe-IBI363 luqalisiwe, ukuze kunyangwe i-IO-naive mucosal okanye i-acral melanoma.
Ngaphezu koko, i-IBI363 ifumene i-fast track indications ezimbini (FTD) ezivela kwi-US FDA, zonyango lwe-melanoma kunye ne-squamous NSCLC, ngokwahlukeneyo. I-IBI363 ikwafumene i-thrust therapy indication evela kwi-NMPA yaseTshayina yonyango lwe-melanoma.
I-Innovent Inikezela ngeDatha yeKliniki yeSigaba soku-1 seProtein ye-PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) kwiMelanoma kwiNtlanganiso yoNyaka ye-ASCO ka-2024.
Abantu abangama-67 abane-melanoma ephucukileyo okanye esasazekileyo abangazange bayifumane okanye abanganyamezelaniyo nonyango oluqhelekileyo babhalisiwe baza bafumana i-IBI363 ngemithambo kumanqanaba edosi aphakathi kwe-100 μg/kg QW kunye ne-2 mg/kg Q3W. Abantu abangama-89.6% bafumene unyango lwangaphambili lwe-immunotherapy, kwaye abangama-61.2% bafumene iindlela ezi-≥ ezimbini zonyango lwangaphambili lwenkqubo. Abantu abangama-25.4% bafumene unyango lwangaphambili lwesibindi kwaye abangama-70.1% bafumene uhlobo lwe-acral okanye lwe-mucosal.
Ukususela nge-11 kaJanuwari 2024, abantu abangama-57 babenovavanyo lwe-tumor emva kwesiseko olunye ubuncinane. Eyona mpendulo ilungileyo iyonke yayiyimpendulo epheleleyo (CR) kumntu omnye, impendulo engaphelelanga (PR) kubantu abali-15 ngokwahlukeneyo. Izinga lempendulo iyonke (ORR) yayiyi-28.1% (95%CI: 17.0-41.5) kwaye i-DCR yayiyi-71.9% (95%CI: 58.5-83.0). Kwizifundo ezingama-25 ezinyangiweyo ze-immunotherapy (IO) kwiqela le-1mg/kg yedosi ye-Q2W (n=25), i-ORR yayiyi-32.0% (95%CI: 14.9-53.5), i-DCR yayiyi-80.0% (95%CI: 59.3-93.2).
Ngokuphathelele ukhuseleko, abantu abali-16 (23.9%) babeneziganeko ezingalindelekanga zonyango zebanga ≥3 (ii-TEAE). Ezona ziphumo zixhaphakileyo ze-TEAE yayiyi-arthralgia (34.3%), i-hyperthyroidism (29.9%), kunye ne-anemia (25.4%). Iziganeko ezingalunganga ezinxulumene nomzimba (ii-irAE) zebanga ≥3 zenzeka kubantu abasi-8 (11.9%). Akukho TRAE ekhokelele ekufeni eyenzekileyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha lokuthumela: Epreli-01-2025