Ku ya 17 Nyakanga 2025 – Innovent Biologics yatangaje ko Nature Medicine yasohoye ibyavuye mu bushakashatsi bwa Icyiciro cya 1 ku buvuzi bwa IBI343, umuti urwanya CLDN18.2 ADC, wo kuvura indwara y’agakoko gatera indwara mu nda/gastroesophageal (G/GEJ). Isohoka ryasohotse muri iki kinyamakuru mpuzamahanga cy’ubushakashatsi rigaragaza ko uburyo bwo kuvura buzwi cyane kandi ko ari intambwe ikomeye mu iterambere ry’Ubushinwa mu guteza imbere imiti mishya irwanya kanseri. Hashingiwe ku byavuye mu bushakashatsi, igerageza ry’ikizamini cya gatatu mu turere twinshi (G-HOPE-001, NCT06238843) ryatangijwe mu 2024 kugira ngo hakorwe isuzuma rya IBI343 nk'uburyo bwiza kandi bwizewe bwo kuvura abarwayi bafite G/GEJ AC iteye imbere.
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.
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Kanseri yo mu gifu ikomeje kuba imwe mu ndwara zikunze kugaragara cyane ku isi. Dukurikije imibare ya GLOBOCAN 2022, iza ku mwanya wa gatanu mu ndwara zikunze kugaragara cyane ndetse ikaba n'iya gatanu mu ndwara zitera impfu zikomoka kuri kanseri ku isi, aho abantu bashya bagera ku 970.000 bandura n'abapfa 660.000 buri mwaka. Buri mwaka, Ubushinwa butangaza ko abantu bashya 359.000 bandura n'abapfa 260.000 bazize kanseri y'igifu, bangana na 37.0% na 39.4% by'abantu bose ku isi, ibi bikaba bigaragaza ko hari ikibazo gikomeye kidakemutse mu buvuzi.
CLDN 18.2 ni poroteyine ifatanye cyane igaragara mu tunyangingo tw’inyuma tw’igifu mu buryo busanzwe. Ubushakashatsi bwakozwe mbere bwagaragaje ko Claudin18.2 igaragara cyane mu bwoko butandukanye bwa kanseri, harimo kanseri y’igifu (60-80%), kanseri ya pancreas (50%), kanseri y’umuhogo (30-50%), na kanseri y’ibihaha (40-60%). Kwibanda kuri CLDN18.2 hifashishijwe antibodies za monoclonal (mAbs) na ADCs ni uburyo bushya bwiza bwo kuvura kanseri y’igifu.
Ubu bushakashatsi bwasohotse ni igerageza ry’ubuvuzi ku rwego rw’isi, ry’icyiciro cya mbere cy’ibizamini (ClinicalTrial.gov identifier: NCT05458219) ryagenewe gusuzuma umutekano, kwihanganira ingaruka mbi n’ubushobozi bw’ibanze bwa IBI343 ku barwayi bafite ibibyimba bikomeye. Hagati ya 26 Ukwakira 2022, na 30 Kamena 2024, abantu 116 bafite G/GEJ adenocarcinoma bashyizwe mu byiciro kugira ngo bahabwe IBI343 monotherapy (8 bari mu kwiyongera naho 108 bari mu kwiyongera).
Ku bijyanye na IBI343 (Anti CLDN18.2 ADC)
IBI343 ni umuti uhuza imiti irwanya CLDN18.2 monoclonal antibody-drug conjugate (ADC) wakozwe na Innovent Biologics. Uhuza by'umwihariko n'uturemangingo twa kanseri tugaragaza CLDN18.2, bigatera ADC gushyirwa mu buryo bwa CLDN18.2. Iyo umaze kwinjira mu turemangingo, umutwaro wa cytotoxic urarekurwa, bigatera kwangirika kwa ADN ndetse amaherezo utuma uturemangingo twa kanseri tubura. Umuti urekurwa ushobora no gukwirakwira mu membrane ya plasma kugira ngo ugere ku turemangingo twegeranye kandi wice, bigatuma "umuntu wica".
Nk'umuti ugezweho wa TOPO1i ADC, IBI343 yagaragaje umutekano wihanganirwa kandi itera imbaraga ibimenyetso by'imikorere muri ubu bushakashatsi bwakozwe mu cyiciro cya 1. Ubu hari ubushakashatsi ku bushobozi bwa IBI343 mu kuvura kanseri y'igifu na kanseri y'agakoko gatera.
Igerageza rya IIBI343 ryo mu cyiciro cya gatatu cy’igerageza ry’indwara y’igifu n’agakoko gatera indwara y’igifu rikorwa mu turere twinshi ubu ririmo gushaka abarwayi (G-HOPE-001, NCT06238843). Ikimenyetso cy’ingenzi cyatanzwe na NMPA yo mu Bushinwa ni Breakthrough Therapy Designation (BTD).
Igerageza rya Icyiciro cya 1 cy’isuzuma rya IBI343 mu turere twinshi rigamije kuvura adenocarcinoma yo mu miyoboro ya pancreas naryo ririmo kwakira abarwayi (NCT05458219). Iki kimenyetso cyahawe izina rya Fast Track Designation (FTD) riva muri Amerika FDA kandi ryahawe BTD na NMPA yo mu Bushinwa.
IBI343 yagaragaje ko itera inkunga uburyo ikibyimba gikira kandi ikagirira akamaro ubuzima.
Ubushakashatsi bwasesenguye amakuru y’imikorere y’abantu bapimwe bafite CLDN18.2 nyinshi (≥75% by’uturemangingo twa kanseri dufite ubukana bw’ibara ry’uruti rw’umura ≥2+ na IHC), mu matsinda abiri ya dose ya 6 mg/kg na 8 mg/kg.
Ku gipimo cya 6 mg/kg (N=31), abarwayi 15 bagaragaje ibisubizo by'igice (PR) barimo abarwayi 9 bafite PR zemejwe n'umurwayi 1 utegereje kwemezwa. ORR yemejwe yari 29.0% (95% CI: 14.2-48.0) naho igipimo cyo kurwanya indwara (DCR) cyari 90.3% (95% CI: 74.2-98.0). Mu barwayi 9 bafite ibisubizo byemejwe, igihe cyo hagati cy'igisubizo (DoR) cyari amezi 5.6 (95% CI: 2.8-7.0). Ikurikirana ry'ikigereranyo ryari amezi 10.6 (95% CI: 9.7-11.5) kuri PFS na OS. Igereranya rya PFS ryari amezi 5.5 (95% CI: 4.1-7.0). Amakuru ya OS ntabwo yari yakuze ukurikije igereranya rya OS ry'amezi 10.8 (95% CI: 6.8-NC). Nyuma yo gusiba amakuru, igisubizo cy'umurwayi umwe usigaye cyemejwe ku ya 26 Nyakanga 2024 maze ORR yemejwe ivugururwa igera kuri 32.3% (95% CI: 16.7-51.4).
Ku gipimo cya 8 mg/kg (N=17), abarwayi 17 bafite CLDN 18.2 yo hejuru ni bo bapimwe. Muri bo, abarwayi 9 bari bafite PR harimo abarwayi 8 bari bemeje PR. ORR yemejwe yari 47.1% (95% CI: 23.0-72.2), naho DCR yari 88.2% (95% CI: 63.6-98.5). Mu barwayi umunani bemejwe ko basubije, igipimo cya DoR cyari amezi 5.7 (95% CI: 2.7-NC). Mu barwayi bose ba G/GEJ adenocarcinoma bafite igipimo cya CLDN18.2 cyo hejuru bavuwe kuri 8 mg/kg (N=19, harimo umurwayi 1 wongeyeho dose n'abarwayi 18 bongerewe dose), igipimo cyakurikiranywe cyari amezi 8.1 (95% CI: 7.6-8.5) kuri PFS na OS. Igipimo cya PFS cyari amezi 6.8 (95% CI: 2.8-7.5), kandi igipimo cya OS nticyagezweho, kandi habayeho ibibazo ku barwayi 36.8%.
IBI343 yanagaragaje umutekano uhanitse
Mu barwayi bose bafite G/GEJ adenocarcinoma (n=116, harimo abarwayi 8 barwaye kanseri y'igifu kuva mu cyiciro cyo kongera igipimo), abarwayi 66.4% (77/116) bari bafite TEAE zo mu cyiciro cya ≥3. TEAE zo mu cyiciro cya ≥3 zikunze kugaragara cyane (≥35%) ni umubare wa neutrophil wagabanutse (28.4%), umubare w'uturemangingo tw'umweru mu maraso waragabanutse (25.9%), na anemia (16.4%). Hari ingaruka nke cyane ku ndwara zo mu gifu zagaragaye mu cyiciro cya ≥3, harimo isesemi ya 1.7% gusa y'icyorezo cya ≥3. Nta ndwara y'ibihaha yo mu cyiciro icyo ari cyo cyose yagaragaye. Uburozi buterwa no kuvurwa bwagabanutse hakoreshejwe uburyo buhagije bwo kuvura, kandi umutekano muri rusange wari wihanganirwa.
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
Indangamuntu ya WeChat: 17801183037
Imeri:myimmnet@163.com
Igihe cyo kohereza: 22 Nyakanga-2025