Ngomhlaka-17 kuNhlolanja 2025, i-Innovent Biologics yamemezela ukuthi iphrotheni yayo yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein, i-IBI363, ithole i-Fast Track Designation yayo yesibili (FTD) evela ku-US Food and Drug Administration (FDA). Lesi sikhundla sisebenza ekwelapheni umdlavuza wamaphaphu we-squamous non-small cell (sqNSCLC) ongasuswa, othuthukisiwe endaweni, noma osakazeke kakhulu oye wathuthuka ngemuva kokwelashwa kwe-anti-PD-(L)1 immune checkpoint inhibitor kanye ne-chemotherapy esekelwe eplatinum. I-IBI363 ibonise ukusebenza kahle nokuphepha okukhuthazayo kuzo zonke izinhlobo eziningi zezimila eziqinile. Njengamanje, i-Innovent yenza izivivinyo zezokwelapha zeSigaba 1/2 se-IBI363 ikakhulukazi eShayina nase-US.
Ukuqokwa Kwethrekhi Esheshayo (i-FTD) kuyinqubo yokulawula eyenzelwe ukusheshisa ukuthuthukiswa kwezokwelapha kanye nokubuyekezwa kwemithi ehloselwe ukwelapha izimo ezibucayi nokubhekana nezidingo zezokwelapha ezingahlangatshezwanga. Abantu abafuna imithi abanikezwa izinzuzo ze-FTD ngokuxhumana okwandisiwe ne-FDA kulo lonke ukuthuthukiswa kwemithi okulandelayo, okungenzeka kusheshise inqubo yabo yokuthuthukiswa kwezokwelapha kanye nenqubo yokugunyazwa.
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 ikhombisa umsebenzi oqinile wokulwa ne-tumor kumamodeli amaningi e-pharmacological athwala i-tumor, kufaka phakathi lawo amelana nama-PD-1 inhibitors namamodeli e-metastatic. Ngaphezu kwalokho, ibonise iphrofayili yokuphepha enhle kumamodeli angaphambi kokwelashwa. Izivivinyo zemitholampilo ziyaqhubeka eShayina, e-United States, nase-Australia ukuhlola ukuphepha kwayo, ukubekezeleleka kanye nokusebenza kwayo kokuqala kubantu abane-malignancies ethuthukile.
Engqungqutheleni Yomhlaba Wonke Yomdlavuza Wamaphaphu (i-WCLC) ngoSepthemba 2024, i-IBI363 yethule izimpawu zokusebenza ezithembisayo ezigulini ezine-sqNSCLC ezazithole ukwelashwa nge-immunotherapy ngaphambilini:
Eqenjini lomthamo ongu-3 mg/kg, phakathi kweziguli ezinamasonto okungenani angu-12 okulandelela noma okuqediwe kocwaningo (n=18), izinga lokuphendula eliqondile (ORR) lalingu-50.0%, kanti izinga lokulawula isifo (DCR) lalingu-88.9%. Ukusinda okuphakathi okungenalo inqubekela phambili (PFS) akukafinyelelwa futhi kusalokhu kulandelwa.
Eqenjini lomthamo ongu-1/1.5 mg/kg, i-PFS ephakathi yayizinyanga ezingu-5.5 (95% CI: 1.5, 8.3), kanti izinga le-PFS lezinyanga ezingu-12 lingu-30.7%, okugqamisa izinzuzo ezingaba khona zesikhathi eside zokwelapha nge-immunotherapy.
Kuwo wonke amaqembu omthamo we-1/1.5/3 mg/kg, iziguli ezine-PD-L1 TPS<1% (n=22) kanye nalabo abane-PD-L1 TPS≥1% (n=22) zithole ama-ORR akhuthazayo angu-36.4% kanye no-31.8%, ngokulandelana, okuphakamisa inzuzo engaba khona ye-IBI363 kubantu abanokubonakaliswa okuphansi kwe-PD-L1.
Mayelana nomdlavuza wamaphaphu we-Squamous Non-Small Cell (sqNSCLC)
Umdlavuza wamaphaphu uyinkinga evame kakhulu futhi ebulalayo emhlabeni wonke, kufaka phakathi eShayina [1], okuletha inselele enkulu empilweni yomphakathi. Umdlavuza wamaphaphu ongewona amaseli amancane (i-NSCLC) ubangela ngaphezu kwama-80% azo zonke izimo zomdlavuza wamaphaphu [2], kanti i-squamous cell carcinoma ingenye yezinhlobo ezimbili ezinkulu [2]. Eminyakeni yamuva nje, izivimbeli zokuhlola amasosha omzimba zishintshe indawo yokwelashwa kwe-NSCLC. Kodwa-ke, ezigulini ezine-NSCLC ezihlulekile ukwelashwa nge-immunotherapy futhi ezingenazo izinguquko zezakhi zofuzo ezishayelayo, kusenesidingo esibalulekile nesiphuthumayo esingahlangatshezwanga sezinketho zokwelapha ezisebenzayo. Ukwelashwa okujwayelekile komugqa wesibili noma wesithathu, i-docetaxel, kunikeza ukusebenza okulinganiselwe, ngokusinda okuphakathi okungenazo inqubekela phambili (PFS) okungaphansi kwezinyanga ezine [3], [4]. Ngenkathi ama-conjugates ezidakamizwa zama-antibody (ama-ADC) ebonise ithemba, izifundo ezimbili ezinkulu zeSigaba 3 ku-squamous NSCLC azikabonisi ukusebenza okwanelisayo.
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.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Izinkomba
1.I-Innovent (innoventbio.com)
Isikhathi sokuthunyelwe: Feb-20-2025