Ku ya 18 Werurwe 2025, Alphamab Oncology yatangaje ko anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 yahawe Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA). Iki cyifuzo ni ukuvura kanseri y’intanga ngore isubira inyuma ya platine (PROC), kanseri y’intanga ngore y’ibanze, cyangwa kanseri y’imiyoboro y’inda, bitagarukira gusa ku rugero rwa HER2.
Gutanga uburyo bwo gutanga imiti ivura indwara ya Breakthrough Therapy Designation bishingiye ku isesengura ry’ubushakashatsi bubiri bw’ubuvuzi, JSKN003-101 na JSKN003-102. JSKN003-101 (NCT05494918) ni ubushakashatsi bw’icyiciro cya mbere cy’ivuriro bukozwe mu buryo bufunguye, butanga umusaruro mwinshi, kandi butanga umusaruro mwinshi bwakorewe muri Ositaraliya, bwandikisha abarwayi bafite ibibyimba bikomeye bya HER2 (IHC≥1+) cyangwa bafite impinduka za HER2. JSKN003-102 (NCT05744427) ni ubushakashatsi bw’icyiciro cya mbere/icya kabiri bwakorewe mu Bushinwa. Igice cya mbere cy’ivuriro cyerekanye abarwayi bafite ibimenyetso by’imiterere ya HER2 (IHC≥1+) cyangwa impinduka za HER2 zabaye ibibyimba bikomeye bya HER2. Igice cya kabiri cyerekanye abarwayi bafite ibibyimba bikomeye bya HER2 hatitawe ku miterere ya HER2 cyangwa uko ihinduka ryabyo rimeze.
Amakuru y’ibanze yavuye mu isesengura ry’ubu bushakashatsi bubiri yatanzwe mu nama y’Umuryango w’Uburayi wita ku ndwara za kanseri (ESMO) yo mu 2024.
Ku itariki ya 15 Nyakanga 2024, abarwayi 50 barwaye PROC bari bamaze guhabwa JSKN003 ku rugero rw'ibipimo bitanu, muri bo harimo abarwayi 2 ku gipimo cya 4.2mg/kg, abarwayi 2 ku gipimo cya 5.2mg/kg, abarwayi 44 ku gipimo cya 6.3mg/kg, umurwayi 1 ku gipimo cya 7.3mg/kg, n'umurwayi 1 ku gipimo cya 8.4mg/kg. Mu barwayi 50 biyandikishije hashingiwe ku isuzuma rya laboratwari, hari abarwayi 17 bafite HER2 expression (IHC 1+, 2+ na 3+) (abarwayi 2 gusa bafite HER2 IHC 3+), abarwayi 17 bafite IHC 0, n'abarwayi 16 nta bisubizo bya HER2 babonye kuko batari barapimwe kugeza ku ya 15 Nyakanga. Abarwayi 28 (56.0%) bari bafite nibura imirongo itatu mbere yo kuvurwa, abarwayi 37 (74.0%) bari barahawe imiti ya bevacizumab, naho abarwayi 28 (56.0%) bari barahawe imiti igabanya ubukana bwa PARP.
Igihe cy’ubuvuzi cyari ibyumweru 12.4 (igihe: ibyumweru 0.7 - 51.0), aho abarwayi 32 (64.0%) bakomeje kuvurwa kugeza ku itariki ntarengwa yo gutanga amakuru.
Umutekano: Mu barwayi 50 bose biyandikishije, abarwayi 3 barwaye indwara y’ibihaha (ILD)/pneumonia. Abarwayi 5 (10.0%) bahuye n’ingaruka mbi ziterwa n’ubuvuzi bwa TRAEs mu cyiciro cya 3, aho inyinshi muri zo ari impiswi (2.0%) na anemia (2.0%). Nta TRAEs zahitanye umuntu.
Ingufu: Mu barwayi 44 bapimwe neza bakorewe isuzuma ry’ingaruka z’ikibyimba nibura rimwe nyuma yo gusuzuma ikibyimba, igipimo cy’ingaruka z’ikibyimba (ORR) cyari 56.8%, aho abarwayi 39 (88.6%) bagaragaje ko ikibyimba cyagabanutse. ORR ku barwayi bafite HER2 IHC 0 na HER2 (IHC 1+, 2+ na 3+) yari 52.9% na 68.8%, uko bikurikirana. Ku barwayi 33 bahawe imiti ya bevacizumab mbere, ORR yari 54.5%, ku barwayi 26 bahawe imiti ya PARP mbere, ORR yari 46.2%.
Ibisubizo byakusanyijwe byagaragaje ko JSKN003 monotherapy ifite ubushobozi bwo kwihanganira no kurinda umutekano, ifite ibimenyetso bifatika ku barwayi bafite PROC ikomeye, kandi imikorere yayo yagaragaye ku barwayi bafite (IHC 1+/2+3+) cyangwa badafite (IHC 0) HER2, hamwe cyangwa badafite bevacizumab na PARP inhibitor mbere.
Ku bijyanye na JSKN003
JSKN003 ni umuti uhuza imiti ibiri ya anti-HER2 bispecific antibody-drug conjugate (bis-ADC), wakozwe mu buryo bwa Alphamab ukoresheje urubuga rwa Glycan-specific conjugation platform. JSKN003 ishobora gufata HER2 ku buso bw'uturemangingo twa kanseri hanyuma ikarekura imiti ibuza topoisomerase I (TOPIi) binyuze mu mikorere ya selile, bityo ikagira ingaruka zo kurwanya kanseri. Ugereranyije n'izindi selile za ADC, JSKN003 yagaragaje ko amaraso y'umuntu ahagaze neza kandi ikagira ingaruka zikomeye ku bantu bareba, ibyo bikaba byagura neza uburyo bwo kuvura.
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.https://www.alphamabonc.com/en/
Igihe cyo kohereza ubutumwa: Werurwe-18-2025