NMPA Ta Amince Da Nadin NDA Kuma Ta Ba Da Shawarar Bitar Muhimmanci Ga Allurar Ipilimumab Ta Innovent, Maganin CTLA-4 Na Farko Na Cikin Gida Na Kasar China, Tare Da Sintilimab A Matsayin Maganin Neoadjuvant Ga Ciwon Daji Na Marasa Lafiya

A ranar 22 ga Fabrairu, 2025, Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Ƙasa (NMPA) ta karɓi Sabon Amfani da Magani (NDA) don allurar ipilimumab (anti-CTLA-4 monoclonal antibody; Lambar R&D: IBI310) kuma an ba ta izinin yin amfani da Priority Review tare da haɗin gwiwar sintilimab a matsayin maganin neoadjuvant don ciwon daji na hanji wanda za a iya cirewa (MSI-H) ko kuma wanda ba shi da daidaito wajen gyarawa (dMMR).

Wannan shine NDA na farko da kasar Sin ta yi amfani da shi wajen hana CTLA-4 a cikin gida, kuma wani muhimmin ci gaba ne da ke karfafa matsayin jagoranci na Sintilimab a fannin maganin rigakafi na cutar kansa. Maganin toshewar garkuwar jiki (ICB) da aka yi niyya ga PD-1 da CTLA-4 ya sauya maganin cutar kansa, ipilimumab tare da sintilimab a matsayin maganin neoadjuvant zai iya kara yawan cire R0, ya cimma cikakkiyar amsawar cututtuka, da kuma rage yawancin marasa lafiya daga nauyin maganin chemotherapy. Ana kuma sa ran wannan sabon magani zai rage yawan sake dawowa da kuma inganta hasashen dogon lokaci, wanda ake sa ran zai amfanar da marasa lafiya da ke fama da cutar kansar hanji ta MSI-H/dMMR idan NDA ta amince da shi.

Amincewa da kuma Bitar Fifiko na NDA ya dogara ne akan sakamakon gwajin asibiti na Mataki na 3 wanda aka tsara bazuwar, wanda aka sarrafa, mai cibiya da yawa, wanda aka tsara shi (NeoShot, NCT05890742) wanda ya kimanta aminci da ingancin ipilimumab tare da sintilimab a matsayin maganin neoadjuvant da kuma idan aka kwatanta da tiyata kai tsaye don ciwon daji na hanji na MSI-H/dMMR. Babban maƙasudin ƙarshen shine ƙimar amsawar cutar (pCR) da kuma rayuwa ba tare da wani abu ba (EFS). Binciken wucin gadi da Kwamitin Kula da Bayanai Mai Zaman Kansa (IDMC) ya yi ya nuna cewa gwajin NeoShot ya cika babban maƙasudinsa.

Ya zuwa ranar 4 ga Fabrairu, 2024, an yi rijistar maki 101 (maza: 55.4%, matsakaicin shekaru: shekaru 56, ECOG PS 1: 54.5%, babban haɗari: 76.2%) kuma an bazu zuwa ga hannu A (n = 52) da hannu B (n = 49). A hannu A, maki 1 ya ƙare da wuri na magani (janyewa). A hannu B, maki 4 sun ƙare da wuri na magani (janyewa 1, 1 ya mutu, 2 sun ci gaba da neoadjuvant sintilimab). An yi tiyatar cirewa da aka tsara a hannu mai maki 51 (98.1%) a hannu mai maki 45 (91.8%) a hannu mai maki 45 a hannu mai maki 91.8. Binciken bayan tiyata ya nuna rashin daidaiton gyaran (pMMR) a hannu mai maki 1 kowanne a hannu mai maki A da hannu mai maki B. Yawan pCR ya kasance 80.0% (40/50, 95%CI: 66.3-90.0) a hannu mai maki A idan aka kwatanta da 47.7% (21/44, 95%CI: 32.5-63.3) a hannu mai maki B (p = 0.0007). Duk wadanda aka yi wa tiyata an yi musu tiyatar cirewa ta R0. Matsakaicin lokacin da ke tsakanin allurar farko ta maganin neoadjuvant da tiyata shine kwanaki 47 (tsakanin: 35-82). Jinkirin tiyata ya faru a cikin maki 3, ciki har da maki 2 a hannu A saboda hypothyroidism na aji 2 (jinkirin kwana 2) da hyperthyroidism na aji 1 (jinkirin kwana 13), da maki 1 a hannu B saboda wani dalili (jinkirin kwana 26). Abubuwan da suka faru na rashin lafiya da suka faru a lokacin jiyya (TEAEs) sun faru a cikin maki 46 (88.5%, maki ≥3 a cikin maki 13) a hannu A da maki 39 (79.6%, maki ≥3 a cikin maki 9) a hannu B. Abubuwan da suka faru na rashin lafiya da suka shafi garkuwar jiki (irAEs) sun faru a cikin maki 22 (42.3%) a hannu A da maki 18 (36.7%) a hannu B. An sami raguwar rashin lafiya da kashi ≥3 a cikin maki 3 a hannu A, gami da myocarditis mai haifar da garkuwar jiki, ileus da enteritis, da kuma maki 4 a hannu B, gami da ƙaruwar alanine aminotransferase, kurji, hypothyroidism da myocarditis. TRAEs masu tsanani sun faru a maki 4 (7.7%) a hannu A da maki 3 (6.1%) a hannu B. TRAE wanda ya haifar da mutuwa ya faru a maki 1 a hannu B (myocarditis).

Game da Ipilimumab

Ipilimumab (Lambar R&D: IBI310) allurar rigakafi ce ta ɗan adam wacce Innovent ya haɓaka ta daban. Ipilimumab na iya ɗaure takamaiman antigen 4 (CTLA-4) mai alaƙa da cytotoxic na lymphocyte, ta haka yana toshe hana ƙwayoyin T da ke shiga tsakani na CTLA-4, yana haɓaka kunnawa da haɓaka ƙwayoyin T, inganta amsawar garkuwar jiki ga ƙari, da kuma cimma tasirin hana ƙari.

NDA don ipilimumab tare da sintilimab a matsayin maganin neoadjuvant don ciwon daji na hanji wanda za a iya cirewa (MSI-H) ko kuma wanda ba shi da isasshen gyara (dMMR) yana ƙarƙashin bitar NMPA kuma an ba shi izinin Bitar Fifiko.

Game da Sintilimab

Sintilimab, wanda aka tallata shi a matsayin TYVYT (allurar sintilimab) a ƙasar Sin, wani nau'in rigakafi ne na PD-1 immunoglobulin G4 monoclonal antibody wanda Innovent da Eli Lilly and Company suka haɓaka tare. Sintilimab wani nau'in rigakafi ne na immunoglobulin G4 monoclonal antibody, wanda ke ɗaure da ƙwayoyin PD-1 a saman ƙwayoyin T, yana toshe hanyar PD-1 / PD-Ligand 1 (PD-L1), kuma yana sake kunna ƙwayoyin T don kashe ƙwayoyin cutar kansa.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

Lambar Waya: 4008803716

Email：myimmnet@163.com

Nassoshi

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

2.Maganin da aka yi wa IBI310 (anti-CTLA-4 antibody) tare da sintilimab (anti-PD-1 antibody) a cikin marasa lafiya da ke fama da rashin kwanciyar hankali na microsatellite-ciwon daji mai ƙarancin gyara/rashin daidaito: Sakamakon wani bincike na mataki na Ib wanda aka yi wa lakabi da bazuwar, wanda aka buɗe. | Mujallar Oncology ta Asibiti (ascopubs.org)

3.信达生物 (innoventbio.com)