NMPA yemeye NDA kandi itanga uburenganzira bwo gusuzuma ishyirwa mu bikorwa ry’inyongera rya Innovent's Ipilimumab injection, umuti wa mbere wo mu gihugu cy’Ubushinwa witwa CTLA-4 inhibitor, hamwe na Sintilimab nk’uburyo bwo kuvura kanseri y’inkondo y’umura

Ku ya 22 Gashyantare 2025, Porogaramu nshya y’imiti (NDA) yo gutera inshinge za ipilimumab (anti-CTLA-4 monoclonal antibody; Kode y’ubushakashatsi n’iterambere: IBI310) yemejwe n’Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe imiti y’ubuvuzi mu Bushinwa (NMPA) kandi gihabwa izina rya Priority Review hamwe na sintilimab nk’uburyo bwo kuvura kanseri y’amara idashobora kuvurwa (MSI-H) cyangwa kanseri y’amara idahuye (dMMR).

Iyi ni yo miti ya mbere ya NDA mu Bushinwa ku muti wo mu rugo wa CTLA-4 ibuza kanseri, ikaba n'ikindi gikorwa gikomeye cyo kongera umwanya w'ubuyobozi bwa sintilimab mu kuvura kanseri. Ubuvuzi bwo gukumira ubudahangarwa bw'umubiri (ICB) bwibanda kuri PD-1 na CTLA-4 bwahinduye uburyo bwo kuvura kanseri, ipilimumab hamwe na sintilimab nk'uburyo bwo kuvura kanseri bushobora kongera igipimo cyo gucibwamo kwa R0, bukanatanga igisubizo cyuzuye cy'indwara, kandi bukagabanya umubare munini w'abarwayi bafite ibibazo bya chemotherapy. Ubu buryo bushya kandi bwitezweho kugabanya igipimo cyo kongera kurwara no kunoza imiterere y'indwara mu gihe kirekire, byitezwe ko buzagirira akamaro abarwayi ba kanseri y'inkondo y'umura ya MSI-H/dMMR iyo NDA yemereye.

Kwemerwa kwa NDA no Gusuzuma Isuzuma ry’Icyiciro cya 3 bishingiye ku byavuye mu igerageza ry’ubuvuzi ryakozwe mu cyiciro cya 3 (NeoShot, NCT05890742) ryasuzumye umutekano n’ubushobozi bwa ipilimumab hamwe na sintilimab nk’ubuvuzi bwa neoadjuvant ndetse no mu kubaga kanseri y’amara ya MSI-H/dMMR. Impanuka z’ibanze ni igipimo cy’ingaruka z’indwara (pCR) hamwe n’ubuzima buzira ingaruka (EFS). Isesengura ry’agateganyo ryakozwe na Komite Yigenga Ishinzwe Gukurikirana Amakuru (IDMC) ryagaragaje ko igerageza rya NeoShot ryujuje intego yaryo y’ibanze.

Ku ya 4 Gashyantare 2024, abantu 101 biyandikishije (abagabo: 55.4%, imyaka isanzwe: imyaka 56, ECOG PS 1: 54.5%, ibyago byinshi: 76.2%) kandi byashyizwe mu buryo butaziguye mu kuboko A (n = 52) no mu kuboko B (n = 49). Mu kuboko A, umuntu 1 yavuye mu kuboko (withdrawal). Mu kuboko B, abantu 4 bavuye mu kuboko hakiri kare (umuntu 1 yavuye mu kuboko, 1 yapfuye, 2 bakomeje kuvurwa na sintilimab). Gucamo ibice byagenwe byakozwe mu byiciro 51 (98.1%) mu kuboko A na 45 (91.8%) mu kuboko B. Isuzuma rya nyuma yo kubagwa ryagaragaje ko hari umuhanga mu gusana (pMMR) utari uhuye neza muri 1 pt buri kimwe mu kuboko A na B. Igipimo cya pCR cyari 80.0% (40/50, 95%CI: 66.3-90.0) mu kuboko A ugereranije na 47.7% (21/44, 95%CI: 32.5-63.3) mu kuboko B (p = 0.0007). Ibipimo byose byakoreweho kubagwa byakozwe mu byiciro R0. Igihe cyo hagati hagati y’igipimo cya mbere cy’ubuvuzi bwa neoadjuvant n’ikibagwa cyari iminsi 47 (intera: 35-82). Gutinda kubagwa byabaye mu byiciro 3 harimo amanota 2 mu kuboko A bitewe na hypothyroidism yo mu cyiciro cya 2 (gutinda iminsi 2) na hyperthyroidism yo mu cyiciro cya 1 (gutinda iminsi 13), na pt 1 mu kuboko B ku zindi mpamvu (gutinda iminsi 26). Ingaruka mbi zigaragara mu kuvura (TEAEs) zabaye mu byiciro 46 (88.5%, grade ≥3 mu byiciro 13) mu kuboko A na 39 (79.6%, grade ≥3 mu byiciro 9) mu kuboko B. Ingaruka mbi zijyanye n'ubudahangarwa bw'umubiri (irAEs) zabaye mu byiciro 22 (42.3%) mu kuboko A na 18 (36.7%) mu kuboko B. Ingaruka mbi ≥3 zabaye mu byiciro 3 mu kuboko A, harimo myocarditis iterwa n'ubudahangarwa, ileus na enteritis, no mu byiciro 4 mu kuboko B, harimo alanine aminotransferase yiyongera, ibisebe, hypothyroidism na myocarditis. TRAE zikomeye zabaye ku manota 4 (7.7%) mu kuboko kwa A na 3 (6.1%) mu kuboko kwa B. TRAE yatumye umuntu apfa yabayeho ku manota 1 mu kuboko kwa B (myocarditis).

Ibyerekeye Ipilimumab

Ipilimumab (kode y’ubushakashatsi n’iterambere: IBI310) ni inshinge y’umubiri w’umuntu yakozwe na Innovent ku giti cye. Ipilimumab ishobora gufata antigen 4 (CTLA-4) ifitanye isano na cytotoxic cytotoxic T lymphocyte), bityo ikabuza CTLA-4 gukumira T cells, igatuma T cells T zikora neza kandi zigakwirakwira, ikongera ubushobozi bw’ubudahangarwa bw’umubiri, kandi ikagera ku ngaruka zo kurwanya kanseri.

NDA yo kuvura kanseri y’inkondo y’umura (ipilimumab) hamwe na sintilimab nk’uburyo bwo kuvura kanseri y’inkondo y’umura (allergies) ishobora kuvurwa (MSI-H) cyangwa kanseri y’inkondo y’umura idahuye (dMMR) iri mu isuzuma rya NMPA kandi yahawe isuzuma ry’ibanze.

Ku bijyanye na Sintilimab

Sintilimab, yagurishijwe nka TYVYT (sintilimab injection) mu Bushinwa, ni antibody ya PD-1 immunoglobulin G4 monoclonal yakozwe na Innovent na Eli Lilly and Company. Sintilimab ni ubwoko bwa antibody ya immunoglobulin G4 monoclonal, ifatana na molekile za PD-1 ku buso bwa T-cells, igafunga inzira ya PD-1 / PD-Ligand 1 (PD-L1), kandi ikongera gukora T-cells kugira ngo yica uturemangingo twa kanseri.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

Nimero ya Terefone: 4008803716

Email：myimmnet@163.com

Amareferensi

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

2.Uburyo bwo kuvura IBI310 (anti-CTLA-4 antibody) hamwe na sintilimab (anti-PD-1 antibody) mu barwayi ba microsatellite idakora neza-kurwanya kanseri y'inkondo y'umura idakora neza: Ibisubizo bivuye mu bushakashatsi bwakozwe ku buryo bwa Ib. | Ikinyamakuru cya Clinical Oncology (ascopubs.org)

3.信达生物 (innoventbio.com)