Ma ʻAukake 11, ua hōʻike ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) ua hāpai ʻia ka noi a InxMed no nā papa IN10018 no ka hoʻolālā ʻana i ka breakthrough therapy, i manaʻo ʻia no ka hui pū ʻana me D-1553 e mālama i ka maʻi kanesa colorectal (CRC) KRAS G12C mutation-positive kūloko holomua a metastatic paha i loaʻa i ʻelua mau laina mua o ka therapy.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
E pili ana iā Ifebemtinib (IN10018)
ʻO Ifebemtinib (IN10018) kahi mea hoʻopaʻa mole liʻiliʻi koho nui ʻia, i hāʻawi ʻia ma ka waha, e kūʻē iā FAK, nona nā synergies koʻikoʻi me kahi ākea o nā ʻano therapeutic. Ma ke ʻano lapaʻau, ua hōʻike ʻia nā synergies therapeutic me ka chemotherapy, nā therapies i kuhikuhi ʻia, a me nā immunotherapy. A hiki i kēia lā, ua mālama ʻia ma mua o 600 mau maʻi me kahi ʻano palekana a me ka tolerability maikaʻi.
Ma ka Hālāwai Makahiki ASCO 2025, ua hoʻokuʻu ʻia nā ʻikepili lapaʻau hou loa mai kahi hoʻokolohua lapaʻau Phase Ib/II (NCT06166836; NCT05379946) e loiloi i ka pono a me ka palekana o ka ifebemtinib (IN10018), kahi mea hoʻopaʻa waha focal adhesion kinase (FAK) i hui pū ʻia me garsorasib (D-1533), kahi mea hoʻopaʻa waha KRAS G12C, ma nā ʻōpū paʻa mutant KRAS G12C.
ʻO ka ʻikepili lapaʻau i hōʻike ʻia ma ka Hālāwai Makahiki ASCO 2025 (Abstract #8629 | Poster Board #109) ua komo pū nā hopena mai nā hui ʻelua:
ʻO ka ʻikepili hahai i ka paʻa o ka cohort lima hoʻokahi i nā poʻe maʻi KRAS G12C-mutant non-small cell lung cancer (NSCLC) laina mua, me ka nānā ʻole i ka hōʻike ʻana o PD-L1, ka poʻe i loaʻa ka lāʻau ifebemtinib + garsorasib.
He hui koho randomized i nā poʻe maʻi maʻi kanesa colorectal KRAS G12C-mutant (CRC) i mālama mua ʻia e hoʻohālikelike ana i ka ifebemtinib + garsorasib versus garsorasib monotherapy.
Ma ka hui NSCLC, ʻo ka hui pū ʻana o ka ifebemtinib a me ka garsorasib, ma ke ʻano he regimen waha ʻelua, chemotherapy-free, ua hōʻike i ka pōmaikaʻi lapaʻau koʻikoʻi e pili ana i nā helu pane kiʻekiʻe a me ka pono paʻa, me ka nānā ʻole i ka hōʻike ʻana o PD-L1, a ma ka hui CRC, ua hōʻike ka hopena i ka pono add-on maopopo e ka ifebemtinib i hoʻohālikelike ʻia me ka monotherapy KRAS inhibitor.
Nā mea koʻikoʻi nui ma ka NSCLC laina mua: Hōʻike ka Dual-Oral Regimen i ka pono paʻa a me ka pōmaikaʻi ola hou
Ma Malaki 31, 2025, ua kākau inoa ʻia he 33 mau maʻi NSCLC laina mua, me ka nānā ʻole i ka hōʻike ʻana o PD-L1, a ua loaʻa iā lākou ka hui pū ʻana o ifebemtinib a me garsorasib, me ka nānā ʻana ma waena o 16.0 mau mahina. Ma mua, ua hōʻike ka hui i kahi Objective Response rate (ORR) o 90.3% (ʻikepili i hōʻike ʻia ma ESMO 2024). Ua hōʻuluʻulu ʻia nā ʻikepili nānā penei:
Ola waena me ka ʻole o ka holomua (mPFS): 22.3 mahina
Ka lōʻihi waena o ka pane ʻana o DOR (mDOR): 19.4 mahina
ʻO ke ola holoʻokoʻa waena (mOS): ʻaʻole i hiki i kēia manawa, me kahi piʻo ola hoʻokiʻekiʻe a hoʻopalahalaha nui e hōʻike ana i ka pōmaikaʻi mau loa.
ʻO ka mea nui, ua hōʻike ka lāʻau lapaʻau i ka hopena mau me ka nānā ʻole i ke kūlana o ka hōʻike ʻana o PD-L1.
Nā ʻIke Koʻikoʻi ma ka CRC i mālama mua ʻia: Hōʻoia ka hoʻokolohua Randomized i ka Synergy me KRAS G12Ci
Ma ʻApelila 21, 2025, ua hoʻokaʻawale ʻia he 36 mau maʻi CRC i mālama mua ʻia ma ka mahele 1:1 e loaʻa i ka hui pū ʻana o ifebemtinib + garsorasib a i ʻole garsorasib wale nō. Ua hiki ke loiloi ʻia nā maʻi āpau ma ke ʻano radiological a ua loiloi ʻia nā pane antitumor a ua hōʻuluʻulu ʻia penei:
ORR: 44.4% (hui pū) vs. 16.7% (mono)
Ka helu kaohi maʻi (DCR): 100.0% (hui pū) vs. 77.8% (mono)
mPFS: 7.7 mahina (hui pū) vs. 4.0 mahina (mono)
mOS: ʻaʻole i hiki i ka lima hui pū ʻia; ua ʻike ʻia ka hoʻokaʻawale mua ʻana ma nā piʻo ola
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Ka manawa hoʻouna: Aug-13-2025