Na ụbọchị iri na otu nke ọnwa Ọgọstụ, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) gosiri na a tụrụ aro ka InxMed tinye ọgwụ IN10018 maka nhazi ọgwụgwọ ọhụrụ, nke e mere maka ijikọta ya na D-1553 iji gwọọ ọrịa kansa eriri afọ KRAS G12C nke gbagoro agbagoro ma ọ bụ nke gbawara agbawa (CRC) nke natara ma ọ dịkarịa ala usoro ọgwụgwọ abụọ gara aga.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Banyere Ifebemtinib (IN10018)
Ifebemtinib (IN10018) bụ ọgwụ na-egbochi obere molekul nke ukwuu, nke a na-enye n'ọnụ, megide FAK, nke nwere njikọ dị ukwuu na ọtụtụ usoro ọgwụgwọ. N'ụlọ ọgwụ, o gosipụtala njikọ ọgwụgwọ na chemotherapy, ọgwụgwọ ezubere iche, na ọgwụ mgbochi ọrịa. Ruo ugbu a, a gwọọla ihe karịrị ndị ọrịa 600 na nchekwa dị mma na nnabata.
Na Nzukọ Kwa Afọ nke ASCO nke afọ 2025, ewepụtara data ahụike kachasị ọhụrụ site na nnwale ahụike Phase Ib/II (NCT06166836; NCT05379946) iji nyochaa irè na nchekwa nke ifebemtinib (IN10018), ihe mgbochi focal adhesion kinase (FAK) ọnụ na njikọta ya na garsorasib (D-1533), ihe mgbochi KRAS G12C ọnụ, na KRAS G12C mutant solid tumors.
Data ahụike e gosipụtara na Nzukọ Kwa Afọ nke ASCO nke afọ 2025 (Nchịkọta #8629 | Boọdụ Poster #109) gụnyere nsonaazụ sitere na otu abụọ:
Data nleba anya ogologo oge nke otu aka na ndị ọrịa KRAS G12C-mutant non-small cell pulmonary cancer (NSCLC) nke mbụ, n'agbanyeghị ngosipụta PD-L1, ndị natara ọgwụgwọ ifebemtinib + garsorasib.
Otu ìgwè mmadụ a na-enweghị usoro na-eme n'ime ndị ọrịa KRAS G12C-mutant colorectal cancer (CRC) a gwọrọla mbụ na-atụnyere ifebemtinib+ garsorasib na garsorasib monotherapy.
N'ime otu NSCLC, njikọta nke ifebemtinib na garsorasib, dị ka usoro abụọ-ọnụ, nke na-enweghị chemotherapy, gosipụtara uru ahụike dị egwu gụnyere ọnụego nzaghachi dị elu na arụmọrụ na-adịgide adịgide, n'agbanyeghị ngosipụta PD-L1, na na otu CRC, nsonaazụ ya gosipụtara arụmọrụ mgbakwunye doro anya site na ifebemtinib ma e jiri ya tụnyere otu ọgwụgwọ inhibitor KRAS.
Isi ihe dị mkpa na NSCLC nke mbụ: Usoro ọnụ abụọ na-egosi arụmọrụ na-adịgide adịgide na uru ndụ na-apụta
Ruo Maachị 31, 2025, e debanyere aha ndị ọrịa NSCLC 33, n'agbanyeghị mmetụta PD-L1, ma nata njikọta nke ifebemtinib na garsorasib, yana nyocha nke etiti nke ọnwa 16.0. Na mbụ, ụlọ ọrụ ahụ akọpụtala ọnụego nzaghachi ebumnuche (ORR) nke 90.3% (data egosiri na ESMO 2024). Ugbu a, a chịkọtara data nsochi ahụ dị ka ndị a:
Nlanarị nke etiti na-enweghị ọganihu (mPFS): ọnwa 22.3
Ogologo oge nzaghachi DOR (mDOR): ọnwa 19.4
Nlanarị etiti (mOS): erutebeghị aka, yana nnukwu usoro ndụ na-ewuli elu ma na-adị larịị nke na-egosi uru na-adịgide adịgide.
Ihe dị mkpa bụ na ọgwụgwọ ahụ gosipụtara irè ya n'agbanyeghị ọnọdụ ngosipụta PD-L1.
Nchọpụta Ndị Dị Mkpa na CRC E Jiworo Mee Ihe Na Mbụ: Nnwale A Na-eme Ka Mmekọrịta Ya na KRAS G12Ci Sikwuo Ike
Dịka ọ dị na Eprel 21, 2025, e nyere ndị ọrịa CRC 36 e nyere ọgwụgwọ n'oge gara aga usoro nhazi 1:1 iji nweta ngwakọta nke ifebemtinib + garsorasib ma ọ bụ garsorasib naanị. E nyochachara ndị ọrịa niile site na redio ma nyochaa ma chịkọta azịza mgbochi etuto ahụ dịka ndị a:
ORR: 44.4% (njikọta) megide 16.7% (mono)
Ọnụego njikwa ọrịa (DCR): 100.0% (njikọta) megide 77.8% (mono)
mPFS: ọnwa 7.7 (njikọta) vs. ọnwa 4.0 (mono)
mOS: erutebeghị aka njikọta ahụ; a hụrụ nkewa mbụ n'ime usoro nlanarị
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Oge ozi: Ọgọst-13-2025