NMPA nabatara NDA ma nye onyinye maka Nhọpụta Ndokwa Mbụ maka Ọgwụ Ipilimumab nke Innovent, Ọgwụ CTLA-4 mbụ nke China, na njikọta ya na Sintilimab dị ka Ọgwụgwọ Neoadjuvant maka Ọrịa Kansa Afọ

Na Febụwarị 22, 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) anabatala ojiji ọgwụ ọhụrụ (NDA) maka ịgba ọgwụ ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) ma nye ya aha Priority Review yana sintilimab dị ka ọgwụgwọ neoadjuvant maka ọrịa kansa eriri afọ nke a na-ewepụ (MSI-H) ma ọ bụ nke na-adịghị arụ ọrụ nke ọma (dMMR).

Nke a bụ NDA mbụ nke China maka ọgwụ mgbochi CTLA-4 n'ime ụlọ na ihe ọzọ dị mkpa na-eme ka ọnọdụ ndu nke sintilimab sikwuo ike na ọgwụgwọ mgbochi kansa. Ọgwụgwọ mgbochi mgbochi ahụ ike (ICB) nke na-elekwasị anya na PD-1 na CTLA-4 agbanweela ọgwụgwọ oncology, ipilimumab na sintilimab dị ka ọgwụgwọ neoadjuvant nwere ike ịbawanye ọnụego mwepụta R0, nweta nzaghachi zuru oke na ọrịa, ma belata ọtụtụ ndị ọrịa site na ibu ọgwụ chemotherapy adjuvant. A na-atụkwa anya na ọgwụgwọ ọhụrụ a ga-ebelata ọnụego nlọghachi azụ ma melite amụma ogologo oge, nke a na-atụ anya na ọ ga-abara ndị ọrịa kansa eriri afọ MSI-H/dMMR uru mgbe NDA kwadoro.

Nkwenye nnabata na NDA na Nyocha Mbụ dabere na nsonaazụ sitere na nnwale ahụike nke usoro atọ (NeoShot, NCT05890742) nke nyochachara nchekwa na irè nke ipilimumab jikọtara ya na sintilimab dị ka ọgwụgwọ neoadjuvant yana ma e jiri ya tụnyere ịwa ahụ radical kpọmkwem maka kansa eriri afọ MSI-H/dMMR. Isi ihe njedebe bụ ọnụego nzaghachi zuru oke (pCR) na ndụ na-enweghị ihe omume (EFS). Nyocha nwa oge nke Kọmitii Nlekota Data Onwe (IDMC) gosiri na nnwale NeoShot erutela isi njedebe ya.

Dịka ọ dị na Febụwarị 4, 2024, e debara aha mmadụ 101 (ndị ikom: 55.4%, afọ etiti: afọ 56, ECOG PS 1: 54.5%, ihe egwu dị elu: 76.2%) ma tinye ya n'ime ogwe aka A (n = 52) na ogwe aka B (n = 49). N'aka A, mmadụ 1 kwụsịrị ọgwụgwọ n'oge (ịkwụsị). N'aka B, mmadụ 4 kwụsịrị ọgwụgwọ n'oge (otu mwepụ, otu nwụrụ, mmadụ 2 gara n'ihu na neoadjuvant sintilimab). E mere mwepụ ọgwụgwọ nke oge a na-eme atụmatụ na 51 (98.1%) na ogwe aka A na 45 (91.8%) na ogwe aka B. Nyocha mgbe a wachara ahụ gosiri na ọ naghị arụ ọrụ nke ọma (pMMR) na 1 pt nke ọ bụla na ogwe aka A na ogwe aka B. Ọnụego pCR ahụ bụ 80.0% (40/50, 95%CI: 66.3-90.0) na ogwe aka A megide 47.7% (21/44, 95%CI: 32.5-63.3) na ogwe aka B (p = 0.0007). Ndị niile e mere ịwa ahụ nwere mwepụ R0. Oge etiti n'etiti ọgwụ mbụ nke ọgwụgwọ neoadjuvant na ịwa ahụ bụ ụbọchị 47 (oke: 35-82). Nkwụsị ịwa ahụ mere na 3, gụnyere 2 pts na ogwe aka A n'ihi hypothyroidism nke ọkwa 2 (nkwụsị ụbọchị 2) na hyperthyroidism nke ọkwa 1 (nkwụsị ụbọchị 13), na 1 pts na ogwe aka B maka ihe ọzọ (nkwụsị ụbọchị 26). Ihe omume ndị na-adịghị mma nke ọgwụgwọ (TEAEs) mere na 46 pts (88.5%, ≥3 na 13 pts) na ogwe aka A na 39 pts (79.6%, ≥3 na 9 pts) na ogwe aka B. Ihe omume ndị na-adịghị mma nke metụtara ahụ ike (irAEs) mere na 22 pts (42.3%) na ogwe aka A na 18 pts (36.7%) na ogwe aka B. ≥3 irAEs mere na 3 pts na ogwe aka A, gụnyere myocarditis nke na-akwalite ahụ ike, ileus na enteritis, na 4 pts na ogwe aka B, gụnyere mmụba alanine aminotransferase, ihe ọkụ ọkụ, hypothyroidism na myocarditis. Ọrịa TRAE siri ike mere na 4 (7.7%) na ogwe aka A na 3 (6.1%) na ogwe aka B. TRAE butere ọnwụ na 1 pt na ogwe aka B (myocarditis).

Banyere Ipilimumab

Ipilimumab (koodu R&D: IBI310) bụ ọgwụ mgbochi monoclonal zuru oke nke Innovent mepụtara n'onwe ya. Ipilimumab nwere ike ijikọ antigen 4 (CTLA-4) nke metụtara cytotoxic T lymphocyte, si otú a gbochie mgbochi mkpụrụ ndụ T nke CTLA-4, na-akwalite mkpali na mmụba nke mkpụrụ ndụ T, na-eme ka nzaghachi ahụ ji alụso ọrịa ọgụ dịkwuo mma, ma na-enweta mmetụta mgbochi nke tumor.

NDA maka ipilimumab yana sintilimab dị ka ọgwụgwọ neoadjuvant maka ọrịa kansa eriri afọ nke a na-akpọ reseptable microsatellite-high insability (MSI-H) ma ọ bụ nke na-adịghị mma maka ndozi (dMMR) dị n'okpuru nyocha NMPA ma enyela ya aha Priority Review.

Banyere Sintilimab

Sintilimab, nke a na-ere dị ka TYVYT (ọgwụ injection sintilimab) na China, bụ ọgwụ mgbochi PD-1 immunoglobulin G4 monoclonal nke Innovent na Eli Lilly and Company mepụtara. Sintilimab bụ ụdị ọgwụ mgbochi immunoglobulin G4 monoclonal, nke na-ejikọ na molekul PD-1 n'elu mkpụrụ ndụ T, na-egbochi ụzọ PD-1 / PD-Ligand 1 (PD-L1), ma na-emegharị mkpụrụ ndụ T iji gbuo mkpụrụ ndụ kansa.

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

Email：myimmnet@163.com

Ntụaka

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

2.Ọgwụgwọ ọhụrụ nke IBI310 (antibody anti-CTLA-4) tinyere sintilimab (anti-PD-1 antibody) n'ime ndị ọrịa nwere microsatellite anọghịzi ike - kansa eriri afọ nke nwere ndozi/enweghị nguzozi: Nsonaazụ sitere na ọmụmụ ihe Ib nke usoro enweghị usoro, nke e dere aha ya nke ọma. | Journal of Clinical Oncology (ascopubs.org)

3.信达生物 (innoventbio.com)