I-Innovent ifumene iSigaba sesibini esiKhawulezayo kwi-FDA yase-US kwi-IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) kwi-Squamous Non-Small Cell Lung Cancer

Ngomhla we-17 kweyoMdumba, ngo-2025, i-Innovent Biologics ibhengeze ukuba iproteni yayo yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein, i-IBI363, ifumene i-Fast Track Designation yayo yesibini (FTD) kwi-US Food and Drug Administration (FDA). Olu phawu lusebenza kunyango lomhlaza wemiphunga we-squamous non-small cell lung cancer (sqNSCLC) ongenakucocwa, ophucukileyo, okanye oqhubekekayo emva konyango lwe-anti-PD-(L)1 immune checkpoint inhibitor kunye ne-platinum-based chemotherapy. I-IBI363 ibonakalise ukusebenza kakuhle nokhuseleko olukhuthazayo kwiintlobo ezininzi ze-tumor eqinileyo. Okwangoku, i-Innovent iqhuba uvavanyo lweklinikhi lweSigaba 1/2 se-IBI363 ikakhulu eTshayina nase-US.

I-Fast Track Designation (FTD) yinkqubo yokulawula eyenzelwe ukukhawulezisa uphuhliso lwezonyango kunye nokuhlaziywa kwamayeza ajoliswe ekunyangeni iimeko ezinzulu kunye nokujongana neemfuno zonyango ezingafezekiswanga. Amayeza anikezelwa yi-FTD ngenxa yonxibelelwano olwandisiweyo ne-FDA kulo lonke uphuhliso lwamayeza olulandelayo, nto leyo enokuthi ikhawulezise uphuhliso lwawo lwezonyango kunye nenkqubo yokuvunywa.

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 lweklinikhi luyaqhubeka ngoku eTshayina, e-United States, nase-Australia ukuvavanya ukhuseleko lwayo, ukunyamezeleka kunye nokusebenza kwayo kwangaphambili kubantu abane-malignancies ephezulu.

KwiNgqungquthela yeHlabathi yoMhlaza weMiphunga (WCLC) ngoSeptemba 2024, i-IBI363 ibonise imiqondiso ethembisayo yokusebenza kakuhle kwizigulane ezine-sqNSCLC ezazifumene unyango lwe-immunotherapy ngaphambili:

Kwiqela ledosi ye-3 mg/kg, phakathi kwezigulane ezineeveki ezili-12 zokulandelela okanye ukugqiba uphando (n=18), izinga lokuphendula elijolise ngqo (ORR) yayiyi-50.0%, kwaye izinga lokulawula isifo (DCR) yayiyi-88.9%. I-median progression-free survival (PFS) ayikafikelelwa kwaye isalandelwa.

Kwiqela ledosi ye-1/1.5 mg/kg, i-PFS ephakathi yayiziinyanga ezi-5.5 (95% CI: 1.5, 8.3), kunye nezinga le-PFS leenyanga ezili-12 eliyi-30.7%, nto leyo ebonisa iingenelo ezinokubakho zexesha elide ze-immunotherapy.

Kuwo onke amaqela edosi ye-1/1.5/3 mg/kg, izigulane ezine-PD-L1 TPS<1% (n=22) kunye nezo zine-PD-L1 TPS≥1% (n=22) zifumene ii-ORR ezikhuthazayo ze-36.4% kunye ne-31.8%, ngokulandelelana, nto leyo ebonisa ukuba i-IBI363 inenzuzo enokubakho kubantu abane-PD-L1 ababonisa ukungabi namandla.

Malunga nomhlaza wemiphunga we-Squamous Non-Small Cell (sqNSCLC)

Umhlaza wemiphunga lolona hlobo lomhlaza luxhaphakileyo nolubulalayo kwihlabathi liphela, kuquka naseTshayina [1], nto leyo ebangela umngeni omkhulu kwimpilo yoluntu. Umhlaza wemiphunga ongengoweeseli ezincinci (i-NSCLC) ubangela ngaphezu kwama-80% azo zonke iimeko zomhlaza wemiphunga [2], kunye ne-squamous cell carcinoma yenye yezona ntlobo zimbini ziphambili [2]. Kwiminyaka yakutshanje, izithinteli zokujonga amajoni omzimba zitshintshe imeko yonyango lwe-NSCLC. Nangona kunjalo, kwizigulane ezine-NSCLC ezingaphumelelanga kunyango lwe-immunotherapy kwaye zingenazo iinguqu ze-driver gene, kusekho isidingo esibalulekileyo nesingxamisekileyo esingafezekiswanga seendlela zonyango ezisebenzayo. Unyango oluqhelekileyo lwesibini okanye lwesithathu, i-docetaxel, lubonelela ngempumelelo elinganiselweyo, kunye nokusinda okuphakathi okungenankqubela phambili (PFS) okungaphantsi kweenyanga ezine [3], [4]. Ngelixa ii-antibody-drug conjugates (ADCs) zibonise ithemba, izifundo ezibini ezinkulu zeSigaba sesi-3 kwi-squamous NSCLC azikabonisi ukusebenza okwanelisayo.

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.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

1.I-Innovent (innoventbio.com)

2.I-MA11.04 I-First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 Kwizigulane ezine-Advanced Non-Small Cell Lung Cancer kwiSifundo seSigaba soku-1 – ScienceDirect