Iipilisi ze-IN10018 ezicetywayo zokuchonga unyango oluphuhlileyo eTshayina: Ukujolisa kwiKRAS G12C+ Umhlaza weColorectal ngokudibeneyo ne-D-1553, Uvavanyo lweKlinikhi oluqhubekayo kwiiteknoloji ezintsha zokulwa nomhlaza​

Ngomhla we-11 kweyeThupha, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libonise ukuba isicelo se-InxMed seethebhulethi ze-IN10018 sicetyisiwe ukuze kuchongwe unyango oluphucukileyo, olujoliswe ekudityanisweni ne-D-1553 ukunyanga umhlaza we-colorectal we-KRAS G12C ophucukileyo okanye osasazekileyo (i-CRC) oye wafumana ubuncinane iindlela ezimbini zonyango zangaphambili.

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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

I-ID ye-WeChat: 17801183037

Email:myimmnet@163.com

Malunga ne-Ifebemtinib (IN10018)

I-Ifebemtinib (IN10018) sisithinteli semolekyuli encinci esikhethwa kakhulu, esinikwa ngomlomo, esichasene ne-FAK, esinobudlelwane obubalulekileyo kunye neendlela ezahlukeneyo zonyango. Ngokwezonyango, ibonakalise ubudlelwane bonyango kunye ne-chemotherapy, unyango olujoliswe kuyo, kunye ne-immunotherapy. Ukuza kuthi ga ngoku, izigulane ezingaphezu kwama-600 zinyangwe ngendlela ekhuselekileyo nefanelekileyo.

KwiNtlanganiso yoNyaka ye-ASCO ka-2025, ikhuphe idatha yamva nje yeklinikhi evela kuvavanyo lweklinikhi lweSigaba se-Ib/II (NCT06166836; NCT05379946) ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-ibemtinib (IN10018), i-oral focal adhesion kinase (FAK) inhibitor kunye ne-garsorasib (D-1533), i-oral KRAS G12C inhibitor, kwi-KRAS G12C mutant solid tumors.

Idatha yeklinikhi evezwe kwiNtlanganiso yoNyaka ye-ASCO ka-2025 (Isishwankathelo #8629 | Ibhodi yePowusta #109) ibandakanya iziphumo ezivela kumaqela amabini:

Idatha yokulandelela ukuqina kweqela lengalo enye kwizigulane zomhlaza wamaphaphu ezingezizo ezincinci ze-KRAS G12C eziguqulweyo (i-NSCLC) zodidi lokuqala, nokuba zinjani na iimpawu ze-PD-L1, ezifumene unyango lwe-ibebemtinib + garsorasib.

Iqela elingacwangciswanga kwizigulane ze-KRAS G12C-mutant colorectal cancer (CRC) ezinyangwe ngaphambili zithelekisa i-ibemtinib+ garsorasib kunye ne-garsorasib monotherapy.

Kwiqela le-NSCLC, indibaniselwano ye-ibemtinib kunye ne-garsorasib, njengonyango olusetyenziswa ngomlomo kabini, olungenazo iichemotherapy, ibonakalise inzuzo enomdla yeklinikhi kubandakanya amazinga aphezulu okuphendula kunye nokusebenza okuhlala ixesha elide, nokuba i-PD-L1 ibonakaliswa njani, kwaye kwiqela le-CRC, isiphumo sibonise ukusebenza okucacileyo kokongeza yi-ibemtinib xa kuthelekiswa ne-KRAS inhibitor monotherapy.

Izinto Ezibalulekileyo Ezibalulekileyo Kwi-NSCLC Yomgca Wokuqala: I-Dual-Oral Regimen Ibonisa Ukusebenza Okuhlala Ixesha Elide kunye Nenzuzo Yokusinda Evelayo

Ukusukela nge-31 kaMatshi 2025, izigulane ezingama-33 ze-NSCLC zodidi lokuqala, nokuba zinjani na iimpawu ze-PD-L1, zabhaliswa zaza zafumana indibaniselwano ye-ibebemtinib kunye ne-garsorasib, kunye nokulandelelana okuphakathi kweenyanga ezili-16.0. Ngaphambili inkampani ibike izinga leNjongo yoMpendulo (ORR) le-90.3% (idatha evezwe kwi-ESMO 2024). Idatha yokulandelela ngoku ishwankathelwe ngolu hlobo lulandelayo:

Ukusinda okuphakathi okungenankqubela phambili (mPFS): iinyanga ezingama-22.3

Ubude obuphakathi bempendulo i-DOR (mDOR): Iinyanga ezili-19.4

Ukusinda okuqhelekileyo okuphakathi (mOS): akukafikelelwa, kunye negophe lokusinda eliphakamileyo nelithe tyaba elibonisa inzuzo ehlala ixesha elide.

Okubalulekileyo kukuba, unyango lubonakalise ukusebenza kakuhle rhoqo nokuba imeko yokubonakaliswa kwe-PD-L1 injani na.

Iziphumo eziphambili kwi-CRC eyayiphathwe ngaphambili: Uvavanyo oluNgacwangciswanga luqinisekisa ukusebenzisana ne-KRAS G12Ci

Ukusukela nge-21 ka-Epreli, ngo-2025, izigulane ezingama-36 ze-CRC ezazinyangwe ngaphambili zanikwa i-1:1 ngokungalinganiyo ukuze zifumane indibaniselwano ye-ibebemtinib + garsorasib okanye i-garsorasib yodwa. Zonke izigulane zavavanywa ngokwe-radiological kwaye iimpendulo zokulwa nomhlaza zavavanywa zaza zashwankathelwa ngolu hlobo lulandelayo:

I-ORR: 44.4% (i-combo) vs. 16.7% (i-mono)

Izinga lokulawula izifo (DCR): 100.0% (i-combo) vs. 77.8% (i-mono)

i-mPFS: iinyanga eziyi-7.7 (i-combo) xa kuthelekiswa neenyanga eziyi-4.0 (i-mono)

i-mOS: ayikafikelelwa kwingalo edibeneyo; ukwahlukana kwangethuba kubonwa kwiindlela zokusinda

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

I-ID ye-WeChat: 17801183037

Email:myimmnet@163.com

微信图片_20241115181717

 


Ixesha lokuthumela: Agasti-13-2025