Limertinib meriri nkwenye na China maka EGFR T790M+ NSCLC

Na Jenụwarị 16, 2025, Ụlọ Ọrụ Nlekọta Ngwaahịa Ahụike Mba nke China (NMPA) akwadola ojiji ọgwụ ọhụrụ (NDA) nke limertinib maka ọgwụgwọ ndị okenye nwere ọrịa kansa akpa ume EGFR T790M nke a na-akpọ NSCLC nke nwere ike ime ka ọ dị njọ ma ọ bụ nke na-agbanwe agbanwe.

Banyere Limertinib

Limertinib bụ ọgwụ EGFR TKI nke a na-enye site n'ọnụ, nke ọgbọ nke atọ nwere ikike nke aka ya, nke NMPA nke China kwadoro maka ọgwụgwọ ndị ọrịa toro eto nwere ọrịa kansa akpa ume nke EGFR T790M nke a na-akpọ "notle cell lung cancer" (NSCLC) ma ọ bụ nke a na-akpọ "metastatic". NDA nke abụọ dị n'okpuru nyocha NMPA maka ọgwụgwọ mbụ nke ndị ọrịa toro eto nwere NSCLC nke dị elu ma ọ bụ nke nwere metastatic bu EGFR exon 19 deletions ma ọ bụ exon 21 L858R mutations.

Ọgwụ a gosiri ihe ịga nke ọma n'ọmụmụ ihe ahụike nke usoro nke atọ nke nwere ọtụtụ etiti, nke a na-achịkwaghị achịkwa, nke e ji usoro nhazi mee, ma e jiri ya tụnyere irè ya na nchekwa ya na gefitinib n'ọgwụgwọ mbụ nke ndị ọrịa nwere NSCLC dị elu ma ọ bụ nke nwere mgbanwe EGFR. Mgbe emechara ihe ndị bụ isi, a ga-egosi nsonaazụ ya na ogbako agụmakwụkwọ na-abịa ma ọ bụ bipụta ya na akwụkwọ akụkọ agụmakwụkwọ.

Mkpebi iwu ahụ ka e ji data sitere na nnwale nke usoro 2b dị mkpa (NCT03502850) kwado ya. Nke a bụ ọmụmụ otu aka, nke mepere emepe, nke usoro 2b emere n'ụlọ ọgwụ 62 dị iche iche na mba China. Ndị ọrịa nwere NSCLC dị elu ma ọ bụ nke gbasaara n'ógbè ahụ nwere mgbanwe EGFR T790M n'ime anụ ahụ ma ọ bụ plasma ọbara nke a kwadoro n'etiti ndị gara n'ihu mgbe e mechara ihe mgbochi EGFR tyrosine kinase nke ọgbọ mbụ ma ọ bụ nke abụọ ma ọ bụ ndị nwere mgbanwe EGFR T790M mbụ.

Site na Julaị 16, 2019, ruo Maachị 10, 2021, e debanyere aha ndị ọrịa 301 ma malite ọgwụgwọ limertinib. Ndị ọrịa niile banyere na nhazi nyocha zuru oke na nchekwa. Mgbe ụbọchị njedebe data gasịrị na Septemba 9, 2021, mmadụ 76 (25.2%) nọgidere na-agwọ ọrịa. Oge nleba anya etiti bụ ọnwa 10.4. Dabere na nhazi nyocha zuru oke, ORR nke kọmitii nyocha onwe ya tụlere bụ 68.8% yana ọnụego njikwa ọrịa bụ 92.4%. PFS etiti bụ ọnwa 11.0, DoR etiti bụ ọnwa 11.1, a ruteghịkwa OS etiti. E nwetara azịza ebumnuche n'ofe obere ngalaba niile akọwapụtara. Maka ndị ọrịa 99 (32.9%) nwere nsogbu sistemụ akwara etiti (CNS), ORR bụ 64.6%, PFS etiti bụ ọnwa 9.7 (95% CI: 5.9–11.6), ebe DoR etiti bụ ọnwa 9.6. Maka ndị ọrịa 41 nwere mmerụ ahụ CNS a na-enyocha, CNS-ORR akwadoro bụ 56.1% na CNS-PFS etiti bụ ọnwa 10.6.

N'ime nchekwa, ndị ọrịa 289 (96.0%) nwetara opekata mpe otu ihe ọjọọ metụtara ọgwụgwọ (TRAE), nke kachasị bụ afọ ọsịsa (81.7%), ọbara ọgbụgba (32.6%), ọkụ ọkụ (29.9%), na anorexia (28.2%). Ọkwa ≥3 TRAE mere na ndị ọrịa 104 (34.6%), nke kachasị gụnyere afọ ọsịsa (13.0%), hypokalemia (4.3%), ọbara ọgbụgba (4.0%), na ọkụ ọkụ (3.3%). TRAE butere nkwụsị dose na ịkwụsị dose mere na 24.6% na 2% nke ndị ọrịa, n'otu n'otu. Enweghị TRAE butere ọnwụ.

Mmechi

A chọpụtara na Limertinib (ASK120067) nwere irè dị mma ma dịkwa mma maka ọgwụgwọ ndị ọrịa nwere NSCLC nke nwere mgbanwe EGFR T790M ma ọ bụ nke nwere nnukwu nsogbu.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

Nọmba ekwentị: 4008803716

Email：myimmnet@163.com

Ntụaka

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.Innovent na ASK Pharm kwupụtara nkwado NMPA maka Limertinib, ọgwụ EGFR nke ọgbọ nke atọ maka ọgwụgwọ ọrịa kansa akpa ume (prnewswire.com)

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