ADC Sac-TMT ya Kelun-Biotech yahawe urwego rwo kuvura mu Bushinwa

Ku ya 11 Kamena, Kelun-Biotech yatangaje ko ikigo cyakoze imiti ya TROP2 ADC sac-TMT (佳泰莱) cyigenga, hamwe na antibody ya PD-L1 monoclonal tagitanlimab (科泰莱), cyahawe isura ya Breakthrough Therapy (BTD) n'Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyo mu Bushinwa mu rwego rwo kuvura abarwayi ba kanseri y'ibihaha idasanzwe cyangwa idafite imiterere y'uturemangingo duto (NSCLC) badafite imiterere y'uturemangingo.

Sac-TMT, igikoresho cy'ingenzi cy'iyi sosiyete, ni TROP2 ADC nshya y'umuntu aho iyi sosiyete ifite uburenganzira ku mutungo bwite mu by'ubwenge, yibanda ku bibyimba bikomeye nka NSCLC, kanseri y'ibere (BC), kanseri y'igifu (GC), ibibyimba by'abagore, n'ibindi. Sac-TMT yakozwe ifite uburyo bushya bwo guhuza umutwaro, inhibitor ya topoisomerase I ikomoka kuri belotecan ifite ikigereranyo cya antibody (DAR) cya 7.4. Sac-TMT imenya by'umwihariko TROP2 ku buso bw'uturemangingo tw'ibibyimba binyuze mu budahangarwa bwa monoclonal buhuza anti-TROP2, hanyuma ikemurwa n'uturemangingo tw'ibibyimba hanyuma ikarekura KL610023 mu ngirabuzima fatizo. KL610023, nk'inzitizi ya topoisomerase I, itera kwangirika kwa ADN ku turemangingo tw'ibibyimba, bigatuma uturemangingo tw'uturemangingo duhagarara kandi tukagira apoptosis. Byongeye kandi, inarekura KL610023 mu bidukikije by'ibibyimba. Bitewe nuko KL610023 ishobora kwinjira mu ruhu, ishobora gutuma habaho ingaruka zo kureba inyuma, cyangwa mu yandi magambo kwica uturemangingo twa kanseri twegeranye.

Iyi gahunda yo kuvura indwara ishingiye ku mibare y’ubushobozi n’umutekano yavuye mu itsinda ritari irya squamous ry’inyigo ya Phase II OptiTROP-Lung01.

Ibisubizo by’ubushakashatsi bwa OptiTROP-Lung01 Phase II, bwasuzumye sac-TMT hamwe na KL-A167 (antibody monoclonal anti-PD-L1) nk’uburyo bwa mbere bwo kuvura abarwayi ba NSCLC bakuze badafite gene y’umushoferi, byagaragajwe mu nama ngarukamwaka ya CSCO yo mu 2024.

Ibyavuye mu bushakashatsi byagaragaje ko: Ku itsinda rya 1A, ikurikirana ry’igihembwe ryari amezi 14.0, aho igipimo cy’ubutabazi (ORR) cya 48.6% (18/37, abarwayi 2 bategereje kwemezwa), igipimo cyo kurwanya indwara (DCR) cya 94.6%, igipimo cy’igihembwe cyo kubaho kidashingiye ku iterambere (PFS) cya mezi 15.4 (95% CI: 6.7, NE), n’igipimo cya PFS cy’amezi 6 cya 69.2%; ku itsinda rya 1B, ikurikirana ry’igihembwe ryari amezi 6.9, aho ORR ya 77.6% (45/58, abarwayi 5 bategereje kwemezwa), DCR ya 100.0%, igipimo cya PFS cy’igihembwe kitaragera, n’igipimo cya PFS cy’amezi 6 cya 84.6%.

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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