Ngomhlaka-11 Agasti, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) iveze ukuthi isicelo se-InxMed samaphilisi e-IN10018 siphakanyisiwe ukuze kunqunywe ukwelashwa okuphumelelayo, okuhloswe ukuthi kuhlanganiswe ne-D-1553 ukwelapha umdlavuza we-colorectal we-KRAS G12C othuthukisiwe noma osakazeke endaweni ethile (CRC) othole okungenani imigqa emibili yokwelashwa ngaphambili.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Mayelana ne-Ifebemtinib (IN10018)
I-Ifebemtinib (IN10018) iyi-molecule encane ekhetha kakhulu, enikezwa ngomlomo, evimbela i-FAK, enokubambisana okuphawulekayo ngezindlela eziningi zokwelapha. Ngokwezokwelapha, ibonise ukusebenzisana kokwelapha nge-chemotherapy, ukwelashwa okuqondiwe, kanye ne-immunotherapy. Kuze kube manje, iziguli ezingaphezu kuka-600 zelashwe ngephrofayili yokuphepha nokubekezeleleka okuhle.
Emhlanganweni Waminyaka Yonke we-ASCO ka-2025, kukhishwe idatha yakamuva yezokwelapha evela esivivinyweni sezokwelapha seSigaba Ib/II (NCT06166836; NCT05379946) ukuhlola ukusebenza kahle nokuphepha kwe-ibemtinib (IN10018), i-oral focal adhesion kinase (FAK) inhibitor ehlanganiswe ne-garsorasib (D-1533), i-oral KRAS G12C inhibitor, kuma-KRAS G12C mutant solid tumors.
Imininingwane yezokwelapha eyethulwe eMhlanganweni Waminyaka Yonke we-ASCO ka-2025 (Isifinyezo #8629 | Ibhodi Leposi #109) ifaka phakathi imiphumela evela emaqenjini amabili:
Idatha yokulandelela ukuqina kweqembu lengalo eyodwa ezigulini zomdlavuza wamaphaphu we-KRAS G12C-mutant non-small cell lung cancer (NSCLC) zomugqa wokuqala, kungakhathaliseki ukuthi i-PD-L1 iveza kanjani, ezathola ukwelashwa nge-ibebemtinib + garsorasib.
Iqembu elingahleliwe ezigulini ze-KRAS G12C-mutant colorectal cancer (CRC) eziphathwe ngaphambilini liqhathanisa i-ibemtinib+ garsorasib ne-garsorasib monotherapy.
Ku-NSCLC cohort, inhlanganisela ye-ibemtinib kanye ne-garsorasib, njengokwelashwa okubili, okungenawo amakhemikhali, ibonise inzuzo ethokozisayo yezokwelapha okuhlanganisa amazinga aphezulu okusabela kanye nokusebenza okuhlala isikhathi eside, kungakhathaliseki ukuthi i-PD-L1 iveza kanjani, kanye naku-CRC cohort, umphumela ubonise ukusebenza kahle okucacile kwe-ibemtinib uma kuqhathaniswa ne-KRAS inhibitor monotherapy.
Okuvelele Okubalulekile ku-NSCLC Yomugqa Wokuqala: Uhlelo Lokusebenzisa Imithi Emibili Lubonisa Ukusebenza Okuhlala Njalo kanye Nenzuzo Yokusinda Evelayo
Kusukela ngomhlaka-31 Mashi 2025, iziguli ezingu-33 zokuqala ze-NSCLC, kungakhathaliseki ukuthi zine-PD-L1 expression, zabhaliswa futhi zathola inhlanganisela ye-ibemtinib kanye ne-garsorasib, kanye nokulandelela okuphakathi kwezinyanga ezingu-16.0. Ngaphambilini inkampani ibike izinga le-Objective Response (ORR) elingu-90.3% (idatha eyethulwe ku-ESMO 2024). Idatha yokulandelela manje ifingqiwe kanje:
Ukusinda okungenalo ukuqhubekela phambili okuphakathi (mPFS): izinyanga ezingu-22.3
Ubude obuphakathi bempendulo i-DOR (mDOR): izinyanga ezingu-19.4
Ukusinda okuphelele okumaphakathi (mOS): akukafinyelelwa, ngejika lokusinda eliphakanyisiwe nelithambile elibonisa inzuzo ehlala isikhathi eside.
Okuphawulekayo ukuthi ukwelashwa kubonise ukusebenza kahle okuqhubekayo kungakhathaliseki isimo sokubonakaliswa kwe-PD-L1.
Okutholakele Okubalulekile ku-CRC Eyelashwa Ngaphambilini: Isivivinyo Esingahleliwe Siqinisekisa Ukusebenzisana ne-KRAS G12Ci
Kusukela ngomhlaka-21 Ephreli 2025, iziguli ezingu-36 ze-CRC ezazelashwe ngaphambilini zanikezwa inhlanganisela ye-ibebemtinib + garsorasib noma i-garsorasib yodwa. Zonke iziguli zahlolwa ngemisebe futhi izimpendulo zokulwa nomdlavuza zahlolwa futhi zafingqwa kanje:
I-ORR: 44.4% (inhlanganisela) uma kuqhathaniswa no-16.7% (i-mono)
Izinga lokulawula izifo (DCR): 100.0% (inhlanganisela) vs. 77.8% (i-mono)
i-mPFS: izinyanga ezingu-7.7 (inhlanganisela) uma kuqhathaniswa nezinyanga ezingu-4.0 (i-mono)
i-mOS: akukafinyelelwa engalweni ehlanganisiwe; ukuhlukana kwasekuqaleni kubonwe kuma-survival curves
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Agasti-13-2025