Sacituzumab Tirumotecan (sac-TMT) Yemejwe kugurishwa mu buryo bwa kabiri na NMPA kuri EGFRm NSCLC

Ku ya 10 Werurwe 2025, Sichuan Kelun-Biotech yatangaje ko umuti wa trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, wahoze ari SKB264/MK-2870) wemewe kugurishwa n’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) nk’ikimenyetso cya kabiri, kikaba ari ukuvura abarwayi bakuru bafite kanseri y’ibihaha ya epidermal growth factor receptor (EGFR) mutant-positive localized advanced or metastatic non-squamous non-small cell cancer (NSCLC) nyuma yo gutera imbere mu kuvura EGFR-tyrosine kinase inhibitor (TKI) na platine-based chemotherapy. Uyu ni wo muti wa mbere wa TROP2 ADC wemejwe kugurishwa muri kanseri y’ibihaha ku isi yose. Ugereranyije n’uburyo busanzwe bwo kuvura, sac-TMT igabanya cyane inyungu rusange z’aba barwayi zo kurokoka.

Kwemeza gushingiye ku bushakashatsi bw’ingenzi bwakozwe mu byiciro byinshi, bukozwe mu buryo butaziguye, bugenzurwa, kandi bukorwa mu buryo bw’ingenzi (OptiTROP-Lung03) busuzuma imikorere n’umutekano wa sac-TMT monotherapy ya 5mg/kg buri cyumweru gikurikiyeho (Q2W) nk’urushinge rwo mu mitsi ugereranije na docetaxel yo kuvura abarwayi bafite NSCLC ya EGFR-mutant NSCLC yateye imbere cyangwa yangiritse nyuma yo kuvurwa na EGFR-TKI na platinum-based chemotherapy (ikoreshwa mu buryo bukurikiranye cyangwa mu buryo buvanze). Nk’uko byagaragajwe mu isesengura ry’agateganyo ryavuzwe mbere, sac-TMT monotherapy yagaragaje iterambere rikomeye kandi rifite akamaro mu buvuzi mu gipimo cy’ubutabazi bw’ibanze (ORR), kubaho kutagira iterambere (PFS) no kubaho muri rusange (OS) ugereranije na docetaxel.

Ku bijyanye na sac-TMT

Sac-TMT ni TROP2 ADC nshya y’umuntu aho ikigo gifite uburenganzira ku mutungo bwite mu by’ubwenge, kigamije ibibyimba 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 7.4 cy’umuti-ku-antibody (DAR). 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 imikorere y’uturemangingo ihagarara kandi ikanapfa. 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.

Mbere, NMPA yemeje ko sac-TMT igurishwa mu Bushinwa ku barwayi bakuru bafite kanseri y'ibere idakira cyangwa yanduye kanseri y'ibere (TNBC) ya kera, bakaba barahawe nibura imiti ibiri mbere (nibura imwe muri zo ikoreshwa mu kuvura kanseri cyangwa yanduye) kandi bakemera indi miti mishya (sNDA) isaba kwemezwa kwa sac-TMT monotherapy ku barwayi bafite EGFR-mutant NSCLC bananiwe nyuma yo kuvurwa na EGFR-TKI.

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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