Pa 31 Marichi, 2025, Innovent Biologics idalengeza kuti Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA) yapereka Breakthrough Therapy Designation (BTD) ya IBI363, puloteni yoyamba ya PD-1/IL-2α-bias bispecific antibody fusion protein, ngati monotherapy yochizira melanoma yosasinthika yomwe sinachiritsidwe m'deralo kapena metastatic mucosal kapena acral melanoma omwe sanalandire chithandizo cha systemic kale.
Zokhudza IBI363 (Puloteni yoyamba ya PD-1/IL-2α-bias bispecific antibody fusion protein)
IBI363 ndi mankhwala oyamba omwe amapangidwa paokha ndi Innovent Biologics. Ndi puloteni ya PD-1/IL-2 bispecific antibody fusion yopangidwa kuti iwonjezere magwiridwe antchito pomwe ikuchepetsa poizoni. IL-2 arm ya IBI363 yapangidwa kuti iwonjezere zotsatira zochizira ndi zotsatirapo zochepa, pomwe PD-1 binding arm imalola PD-1 blockade ndi kusankha IL-2. Mwa kuletsa nthawi yomweyo njira ya PD-1/PD-L1 ndikuyambitsa njira ya IL-2, IBI363 imathandizira kuyang'ana ndi kuyambitsa maselo a T enieni a chotupa. Kafukufuku woyambirira wasonyeza kuti IBI363 ikuwonetsa mphamvu yolimbana ndi chotupa m'mitundu yambiri yamankhwala yokhala ndi chotupa, kuphatikiza omwe amalimbana ndi zoletsa za PD-1 ndi mitundu yofalikira. Kuphatikiza apo, yawonetsa mbiri yabwino yotetezeka m'mitundu yoyambirira.
Mayeso azachipatala a IBI363 akuchitika ku China, United States, ndi Australia kuti awone chitetezo chake, kulekerera kwake, komanso momwe angathandizire anthu omwe ali ndi khansa yapamwamba. Kafukufuku woyamba wofunikira wa IBI363 wayambitsidwa, pochiza IO-naive mucosal kapena acral melanoma.
Kuphatikiza apo, IBI363 yalandira mayina awiri ofulumira (FTD) kuchokera ku US FDA, pochiza melanoma ndi squamous NSCLC, motsatana. IBI363 yalandiranso mayina otsogola kuchokera ku NMPA ya ku China pochiza melanoma.
Innovent Ikupereka Deta Yachipatala ya Gawo 1 ya PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) yoyamba mu Melanoma pa Msonkhano Wapachaka wa ASCO wa 2024.
Anthu 67 omwe ali ndi khansa ya melanoma yomwe yakula kwambiri m'deralo kapena yomwe yafalikira kwambiri omwe sanathe kapena osalolera chithandizo chamankhwala wamba adalembedwa ndipo adalandira IBI363 kudzera m'mitsempha pamlingo wa pakati pa 100 μg/kg QW ndi 2 mg/kg Q3W. 89.6% ya anthu omwe adalandirapo chithandizo cham'mbuyomu cha immunotherapy, ndipo 61.2% ya anthu omwe adalandirapo chithandizo cham'mbuyomu anali ndi mizere ≥ iwiri. 25.4% ya anthu omwe adalandirapo anali ndi khansa ya chiwindi ndipo 70.1% ya anthu omwe adalandirapo anali acral kapena mucosal subtypes.
Pofika pa Januware 11, 2024, anthu 57 adayesedwa kangapo kamodzi kokha pambuyo pa kafukufuku woyamba wa chotupa. Yankho labwino kwambiri linali yankho lathunthu (CR) mwa munthu m'modzi, yankho la gawo (PR) mwa anthu 15 motsatana. Chiŵerengero chonse cha mayankho (ORR) chinali 28.1% (95%CI: 17.0-41.5) ndipo DCR inali 71.9% (95%CI: 58.5-83.0). Mwa anthu 25 omwe adalandira chithandizo cha immunotherapy (IO) m'gulu la 1mg/kg Q2W dose (n=25), ORR inali 32.0% (95%CI: 14.9-53.5), DCR inali 80.0% (95%CI: 59.3-93.2).
Ponena za chitetezo, anthu 16 (23.9%) anali ndi zochitika zoyipa zomwe zachitika mwadzidzidzi (TEAEs) zomwe zidachitika mu giredi ≥3. Matenda ambiri a TEAE anali a arthralgia (34.3%), hyperthyroidism (29.9%), ndi kuchepa kwa magazi m'thupi (25.4%). Zochitika zoyipa zokhudzana ndi chitetezo chamthupi (irAEs) za giredi ≥3 zidachitika mwa anthu 8 (11.9%). Palibe TRAE yomwe idapangitsa kuti munthu afe.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Epulo-01-2025