Ua ʻae ʻo NMPA i ka NDA a hāʻawi i ka Priority Review Designation i ka Innovent's Ipilimumab Injection, ka mea pale CTLA-4 kūloko mua loa o Kina, i hui pū ʻia me Sintilimab ma ke ʻano he Neoadjuvant Treatment no ka maʻi ʻaʻai colon.

Ma ka lā 22 o Pepeluali, 2025, ua ʻae ʻia ka New Drug Application (NDA) no ka inikini ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) e ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) o Kina a ua hāʻawi ʻia i ka hoʻolālā Priority Review i hui pū ʻia me ka sintilimab ma ke ʻano he lāʻau neoadjuvant no ka maʻi ʻaʻai colon microsatellite instability-high (MSI-H) a i ʻole mismatch repair deficient (dMMR).

ʻO kēia ka NDA mua a Kina no kahi mea hoʻopaʻa CTLA-4 kūloko a me kahi hanana koʻikoʻi e hoʻoikaika ana i ke kūlana alakaʻi o sintilimab i ka immunotherapy kanesa. Ua hoʻololi ka lāʻau lapaʻau pale pale (ICB) e pili ana iā PD-1 a me CTLA-4 i ka mālama ʻana i ka oncology, hiki i ka ipilimumab me ka sintilimab ma ke ʻano he lāʻau neoadjuvant ke hoʻonui i ka helu resection R0, hoʻokō i ka pane piha pathological, a hoʻomaha i ka hapa nui o nā maʻi mai nā kaumaha chemotherapy adjuvant. Manaʻo ʻia hoʻi kēia lāʻau lapaʻau hou e hōʻemi i ka helu hoʻi hou a hoʻomaikaʻi i ka prognosis lōʻihi, i manaʻo ʻia e pōmaikaʻi i nā maʻi maʻi kanesa colon MSI-H/dMMR ma hope o ka ʻae ʻia ʻana o NDA.

Hoʻokumu ʻia ka ʻae ʻana o ka NDA a me ka hoʻolālā Priority Review ma nā hopena mai kahi hoʻokolohua lapaʻau randomized, controlled, multicenter, pivotal Phase 3 (NeoShot, NCT05890742) nāna i loiloi i ka palekana a me ka pono o ka ipilimumab i hui pū ʻia me ka sintilimab ma ke ʻano he neoadjuvant therapy a i hoʻohālikelike ʻia me ke ʻoki radical pololei no ka maʻi ʻaʻai colon MSI-H/dMMR. ʻO nā hopena mua ka helu pane piha pathologic (pCR) a me ke ola ʻole hanana (EFS). Ua hōʻike ka loiloi waena e ke Kōmike Nānā ʻIkepili Kūʻokoʻa (IDMC) ua hoʻokō ka hoʻokolohua NeoShot i kona hopena mua.

Ma ka lā 4 o Pepeluali, 2024, ua kākau inoa ʻia he 101 mau helu (kāne: 55.4%, makahiki waena: 56 mau makahiki, ECOG PS 1: 54.5%, pilikia kiʻekiʻe: 76.2%) a ua hoʻokaʻawale ʻia i loko o ka lima A (n = 52) a me ka lima B (n = 49). Ma ka lima A, ua hoʻopau mua ʻia ka lāʻau lapaʻau e 1 pt (withdrawal). Ma ka lima B, ua hoʻopau mua ʻia ka lāʻau lapaʻau e 4 pt (1 i haʻalele, 1 i make, 2 i hoʻomau i ka neoadjuvant sintilimab). Ua hana ʻia ka ʻoki hoʻōla i hoʻonohonoho ʻia ma 51 (98.1%) mau pts ma ka lima A a me 45 (91.8%) mau pts ma ka lima B. Ua hōʻike ka loiloi postoperative i ka mismatch repair-proficient (pMMR) ma 1 pt pākahi ma ka lima A a me ka lima B. ʻO nā helu pCR he 80.0% (40/50, 95%CI: 66.3-90.0) ma ka lima A vs 47.7% (21/44, 95%CI: 32.5-63.3) ma ka lima B (p = 0.0007). ʻO nā pts a pau i loaʻa i ke ʻoki ʻana he R0 resection. ʻO ka manawa waena ma waena o ka mahele mua o ka mālama ʻana neoadjuvant a me ke ʻoki ʻana he 47 mau lā (pae: 35-82). Ua lohi ke ʻoki kino ma 3 mau pts me 2 mau pts ma ka lima A ma muli o ka hypothyroidism papa 2 (2 mau lā lohi) a me ka hyperthyroidism papa 1 (13 mau lā lohi), a me 1 pt ma ka lima B no kekahi kumu ʻē aʻe (26 mau lā lohi). Ua loaʻa nā hanana ʻino emergency treatment (TEAEs) ma 46 mau pts (88.5%, grade≥3 ma 13 pts) ma ka lima A a me 39 pts (79.6%, grade≥3 ma 9 pts) ma ka lima B. Ua loaʻa nā hanana ʻino e pili ana i ka pale ʻana (irAEs) ma 22 mau pts (42.3%) ma ka lima A a me 18 pts (36.7%) ma ka lima B. Ua loaʻa nā irAE papa ≥3 ma 3 mau pts ma ka lima A, me ka myocarditis immune-mediated, ileus a me enteritis, a ma 4 mau pts ma ka lima B, me ka hoʻonui ʻia o ka alanine aminotransferase, ka ʻulaʻula, ka hypothyroidism a me ka myocarditis. Ua loaʻa nā TRAE koʻikoʻi ma 4 (7.7%) mau pts ma ka lima A a me 3 (6.1%) mau pts ma ka lima B. ʻO TRAE i alakaʻi ai i ka make ua loaʻa ma 1 pt ma ka lima B (myocarditis).

E pili ana iā Ipilimumab

ʻO Ipilimumab (R&D code: IBI310) kahi inikini antibody monoclonal kanaka piha i hoʻomohala kūʻokoʻa ʻia e Innovent. Hiki iā Ipilimumab ke hoʻopaʻa pono i ka cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a laila e pale ana i ka pale ʻana o nā cell T i hoʻopili ʻia e CTLA-4, e paipai ana i ka hoʻāla ʻana a me ka hoʻonui ʻana o nā cell T, e hoʻomaikaʻi ana i ka pane pale ʻana o ka maʻi puʻupuʻu, a me ka hoʻokō ʻana i nā hopena anti-tumor.

ʻO ka NDA no ka ipilimumab i hui pū ʻia me ka sintilimab ma ke ʻano he lāʻau neoadjuvant no ka resectable microsatellite instability-high (MSI-H) a i ʻole mismatch repair deficient (dMMR) colon cancer aia ma lalo o ka loiloi NMPA a ua hāʻawi ʻia i ka Priority Review designation.

E pili ana iā Sintilimab

ʻO Sintilimab, i kūʻai ʻia aku ma ke ʻano he TYVYT (sintilimab injection) ma Kina, he PD-1 immunoglobulin G4 monoclonal antibody i hoʻomohala pū ʻia e Innovent lāua ʻo Eli Lilly and Company. ʻO Sintilimab kahi ʻano immunoglobulin G4 monoclonal antibody, kahi e hoʻopaʻa ai i nā molekala PD-1 ma luna o ka ʻili o nā T-cell, e ālai ana i ke ala PD-1 / PD-Ligand 1 (PD-L1), a hoʻāla hou i nā T-cell e pepehi i nā cell kanesa.

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

Email：myimmnet@163.com

Nā Kuhikuhi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.ʻO ka lāʻau lapaʻau Neoadjuvant o IBI310 (antibodi anti-CTLA-4) me sintilimab (antibodi anti-PD-1) i nā poʻe maʻi me ka maʻi kanesa colorectal microsatellite instability-high/mismatch repair-deficient: Nā hopena mai kahi noiʻi randomized, open-labeled, phase Ib. | Journal of Clinical Oncology (ascopubs.org)

3.信达生物 (innoventbio.com)