Thaum Lub Peb Hlis 31, 2025, Innovent Biologics tshaj tawm tias Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau Breakthrough Therapy Designation (BTD) rau IBI363, thawj-hauv-chav kawm PD-1 / IL-2α-bias bispecific antibody fusion protein, ua monotherapy rau kev kho mob ntawm cov mob qog nqaij hlav lossis mob qog nqaij hlav uas tsis tuaj yeem phais tau hauv zos lossis metastatic mucosal lossis acral melanoma uas tsis tau txais kev kho mob systemic ua ntej.
Txog IBI363 (Thawj zaug hauv chav kawm PD-1/IL-2α-bias bispecific antibody fusion protein)
IBI363 yog thawj cov tshuaj uas Innovent Biologics tsim tawm los ntawm nws tus kheej. Nws yog ib qho PD-1/IL-2 bispecific antibody fusion protein uas tsim los txhim kho kev ua haujlwm thaum txo qis kev lom. Lub caj npab IL-2 ntawm IBI363 tau tsim los ua kom zoo dua cov txiaj ntsig kho mob nrog kev txo qis cov kev phiv, thaum lub caj npab khi PD-1 ua rau PD-1 thaiv thiab xa IL-2 xaiv. Los ntawm kev txwv txoj kev PD-1/PD-L1 tib lub sijhawm thiab ua kom txoj kev IL-2 ua haujlwm, IBI363 pab txhawb kev tsom mus rau thiab ua kom cov qe ntshav T tshwj xeeb ntawm cov qog nqaij hlav raug thiab ua haujlwm tau zoo dua. Cov kev tshawb fawb ua ntej kuaj mob tau qhia tias IBI363 ua haujlwm tiv thaiv kab mob qog nqaij hlav ntau yam qauv tshuaj uas muaj cov qog nqaij hlav, suav nrog cov uas tiv taus PD-1 inhibitors thiab cov qauv metastatic. Tsis tas li ntawd, nws tau ua pov thawj tias muaj kev nyab xeeb zoo hauv cov qauv ua ntej kuaj mob.
Kev sim tshuaj IBI363 tam sim no tab tom ua nyob rau hauv Suav teb, Tebchaws Meskas, thiab Australia los ntsuam xyuas nws txoj kev nyab xeeb, kev kam rau siab thiab kev ua haujlwm zoo hauv cov neeg mob uas muaj mob qog nqaij hlav siab heev. Kev tshawb fawb tseem ceeb thawj zaug ntawm IBI363 tau pib lawm, rau kev kho mob ntawm IO-naive mucosal lossis acral melanoma.
Ntxiv mus, IBI363 tau txais ob qho kev xaiv kho mob ceev ceev (FTD) los ntawm US FDA, rau kev kho mob melanoma thiab squamous NSCLC, raws li. IBI363 kuj tau txais kev kho mob tshiab los ntawm NMPA ntawm Tuam Tshoj rau kev kho mob melanoma.
Innovent Nthuav Qhia Theem 1 Cov Ntaub Ntawv Kho Mob ntawm PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) thawj zaug hauv Melanoma ntawm Lub Rooj Sib Tham Txhua Xyoo 2024 ASCO.
Muaj 67 tus neeg mob uas muaj mob melanoma uas kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw uas tsis tau lossis tsis kam rau kev kho mob tus qauv tau raug sau npe thiab tau txais IBI363 intravenously ntawm cov koob tshuaj ntawm 100 μg/kg QW thiab 2 mg/kg Q3W. 89.6% ntawm cov neeg mob tau txais kev kho mob tiv thaiv kab mob ua ntej, thiab 61.2% ntawm cov neeg mob tau ≥ 2 kab ntawm kev kho mob systemic ua ntej. 25.4% ntawm cov neeg mob tau kis mus rau lwm qhov chaw hauv siab thiab 70.1% ntawm cov neeg mob yog acral lossis mucosal subtypes.
Txij li thaum Lub Ib Hlis 11, 2024, muaj 57 tus neeg mob tau muaj tsawg kawg 1 qhov kev ntsuam xyuas qog tom qab pib. Qhov kev teb zoo tshaj plaws yog kev teb tiav (CR) hauv 1 tus neeg mob, kev teb ib nrab (PR) hauv 15 tus neeg mob feem. Qhov feem pua ntawm kev teb tag nrho (ORR) yog 28.1% (95% CI: 17.0-41.5) thiab DCR yog 71.9% (95% CI: 58.5-83.0). Hauv 25 tus neeg mob uas tau kho nrog kev kho mob tiv thaiv kab mob (IO) hauv 1mg / kg Q2W koob tshuaj pawg (n = 25), ORR yog 32.0% (95% CI: 14.9-53.5), DCR yog 80.0% (95% CI: 59.3-93.2).
Hais txog kev nyab xeeb, 16 tus neeg (23.9%) muaj cov teeb meem tshwm sim tsis zoo (TEAEs) qib ≥3 uas yog kev kho mob. Feem ntau cov teeb meem TEAEs yog mob pob qij txha (34.3%), mob hyperthyroidism (29.9%), thiab ntshav tsis txaus (25.4%). Cov teeb meem tshwm sim tsis zoo uas cuam tshuam nrog kev tiv thaiv kab mob qib ≥3 (irAEs) tau tshwm sim hauv 8 tus neeg (11.9%). Tsis muaj TRAE ua rau tuag taus.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Plaub Hlis-01-2025