Limertinib yemerewe mu Bushinwa gukoresha EGFR T790M+ NSCLC

Ku ya 16 Mutarama 2025, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje Porogaramu Nshya y’Imiti ya Limertinib (NDA) mu kuvura abarwayi bakuru bafite kanseri y’ibihaha idakomeye cyangwa isanzwe ya EGFR T790M (NSCLC) yahinduwe mu gace runaka.

Ku bijyanye na Limertinib

Limertinib ni umuti wa EGFR TKI wo mu gisekuru cya gatatu utangwa mu kanwa, ufite uburenganzira ku mutungo bwite, wemejwe na NMPA yo mu Bushinwa mu kuvura abarwayi bakuru bafite kanseri y’ibihaha ya EGFR T790M yahinduwe mu gace runaka cyangwa isanzwe (NSCLC). Indi NDA iri mu isuzuma rya NMPA ku barwayi bakuru bafite NSCLC yahinduwe mu gace runaka cyangwa isanzwe ifite EGFR exon 19 deletions cyangwa exon 21 L858R mutations.

Uyu muti wagaragaje ko watsinze mu igerageza ryakozwe mu byiciro byinshi, ryakozwe ku buryo butaziguye, ritagaragara ku ruhu, kandi rigenzurwa mu cyiciro cya 3, rigereranya akamaro kawo n'umutekano wa gefitinib mu kuvura abarwayi bafite NSCLC yateye imbere cyangwa ifata EGFR mu buryo bwa kera. Iyo iherezo ry'ibanze ribonetse, ibisubizo bizagaragazwa mu nama z'ubushakashatsi ziri imbere cyangwa bigatangazwa mu binyamakuru by'ubushakashatsi.

Umwanzuro w’amategeko washyigikiwe n’amakuru yavuye mu igerageza ry’ingenzi rya phase 2b (NCT03502850). Ubu ni ubushakashatsi bwa phase 2b bwakozwe mu bitaro 62 hirya no hino mu gihugu cy’Ubushinwa. Abarwayi bafite NSCLC yateye imbere cyangwa yanduye bafite impinduka za EGFR T790M mu turemangingo twa kanseri cyangwa mu maraso byakomeje kwiyongera nyuma y’uko EGFR tyrosine kinase inhibitors yo mu gisekuru cya mbere cyangwa icya kabiri cyangwa bafite impinduka za EGFR T790M z’ibanze zashyizwe mu byiciro.

Kuva ku ya 16 Nyakanga 2019, kugeza ku ya 10 Werurwe 2021, abarwayi 301 bose hamwe nibo biyandikishije kandi batangiye kuvurwa na limertinib. Abarwayi bose binjiye mu isesengura ryuzuye n'umutekano. Ku itariki yo gusoza amakuru ku ya 9 Nzeri 2021, 76 (25.2%) bakomeje kuvurwa. Igihe cyo gukurikirana cyari amezi 10.4. Hashingiwe ku isesengura ryuzuye, komite yigenga yagenzuye ORR yari 68.8% naho igipimo cyo kurwanya indwara cyari 92.4%. Igipimo cya PFS cyari amezi 11.0, igipimo cya DoR cyari amezi 11.1, naho igipimo cya OS nticyagezweho. Ibisubizo by'intego byagezweho mu matsinda yose yagenwe mbere. Ku barwayi 99 (32.9%) bafite indwara ya metastases mu mitsi yo mu mutwe (CNS), ORR yari 64.6%, PFS yari 9.7% (95% CI: 5.9–11.6), naho DoR yari 9.6%. Ku barwayi 41 bari bafite ibisebe bya CNS bishobora gupimwa, CNS-ORR yemejwe yari 56.1% naho CNS-PFS yari 10.6%.

Mu rwego rw’umutekano, abarwayi 289 (96.0%) bahuye n’ingaruka mbi imwe ijyanye n’ubuvuzi (TRAE), aho ikunze kugaragara cyane ari impiswi (81.7%), amaraso make (32.6%), ibibyimba (29.9%), na anorexia (28.2%). Indwara za TRAE zo mu rwego rwa ≥3 zabaye ku barwayi 104 (34.6%), aho inyinshi muri zo zigaragara harimo impiswi (13.0%), hypokalemia (4.3%), amaraso make (4.0%), na ibibyimba (3.3%). TRAE zatumye dose ihagarara kandi dose igahagarara zabaye kuri 24.6% na 2% by’abarwayi, uko bikurikirana. Nta TRAE yateye urupfu.

Umwanzuro

Limertinib (ASK120067) yagaragaye ko ifite ubushobozi bwo kuvura abarwayi bafite EGFR T790M-mutated NSCLC yateye imbere cyangwa yanduye.

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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Amareferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) (ask-pharm.com)

3.Innovant na ASK Pharm bahuriye hamwe batangaza ko NMPA yemeye Limertinib, umuti wa EGFR TKI wo mu gisekuru cya gatatu mu kuvura kanseri y'ibihaha (prnewswire.com)

4.https: //www.jto.org/article/S1556-0864 (22) 00267-2 / inyandiko yuzuye