Limertinib Tau Txais Kev Pom Zoo Hauv Suav Teb Rau EGFR T790M+ NSCLC

Thaum Lub Ib Hlis 16, 2025, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo Daim Ntawv Thov Tshuaj Tshiab (NDA) ntawm limertinib rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav EGFR T790M-mutated non-small cell lung cancer (NSCLC) uas tau nce mus rau theem siab lossis kis mus rau lwm qhov.

Txog Limertinib

Limertinib yog ib hom tshuaj EGFR TKI tiam peb uas muab los ntawm qhov ncauj thiab muaj cai tshwj xeeb, thiab tau txais kev pom zoo los ntawm NMPA hauv Suav teb rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav EGFR T790M uas hloov pauv tsis yog qog nqaij hlav me me (NSCLC) uas tau kis mus rau lwm qhov chaw. NDA thib ob tab tom raug tshuaj xyuas los ntawm NMPA rau kev kho mob thawj kab rau cov neeg laus uas muaj mob qog nqaij hlav NSCLC uas tau kis mus rau lwm qhov chaw uas muaj EGFR exon 19 deletions lossis exon 21 L858R mutations.

Cov tshuaj no tau ua tiav hauv kev sim tshuaj theem 3 uas muaj ntau lub chaw, randomized, ob chav dig muag, thiab tswj tau los ntawm kev sib piv nws cov txiaj ntsig thiab kev nyab xeeb ntawm gefitinib hauv kev kho mob thawj zaug rau cov neeg mob uas muaj NSCLC uas tau kis mus rau lwm qhov lossis kis mus rau lwm qhov uas muaj EGFR mutations. Thaum ua tiav qhov kawg tseem ceeb, cov txiaj ntsig yuav raug nthuav tawm ntawm cov rooj sib tham txog kev kawm tom ntej lossis luam tawm hauv cov ntawv xov xwm kev kawm.

Qhov kev txiav txim siab ntawm txoj cai tau txais kev txhawb nqa los ntawm cov ntaub ntawv los ntawm kev sim theem 2b tseem ceeb (NCT03502850), Qhov no yog ib txoj kev tshawb fawb qhib, qhib daim ntawv lo, theem 2b uas tau ua nyob rau ntawm 62 lub tsev kho mob thoob plaws lub tebchaws Suav. Cov neeg mob uas muaj NSCLC hauv zos lossis metastatic nrog EGFR T790M mutations uas tau lees paub hauv nruab nrab hauv cov nqaij mob qog lossis cov ntshav plasma uas tau nce qib tom qab thawj- lossis thib ob-tiam EGFR tyrosine kinase inhibitors lossis nrog thawj EGFR T790M mutations tau raug sau npe.

Txij li thaum Lub Xya Hli 16, 2019, txog rau Lub Peb Hlis 10, 2021, tag nrho muaj 301 tus neeg mob tau sau npe thiab pib kho mob nrog limertinib. Tag nrho cov neeg mob tau nkag mus rau hauv cov txheej txheem tshuaj xyuas tag nrho thiab cov txheej txheem kev nyab xeeb. Los ntawm hnub kawg ntawm cov ntaub ntawv rau lub Cuaj Hlis 9, 2021, 76 (25.2%) tseem kho mob. Lub sijhawm nruab nrab ntawm kev saib xyuas yog 10.4 lub hlis. Raws li cov txheej txheem tshuaj xyuas tag nrho, pawg neeg saib xyuas kev ywj pheej tau soj ntsuam ORR yog 68.8% thiab tus nqi tswj kab mob yog 92.4%. PFS nruab nrab yog 11.0 lub hlis, DoR nruab nrab yog 11.1 lub hlis, thiab OS nruab nrab tsis tau mus txog. Cov lus teb tau ua tiav thoob plaws txhua pawg me me uas tau teev tseg. Rau 99 tus neeg mob (32.9%) uas muaj cov qog nqaij hlav hauv lub paj hlwb (CNS) metastases, ORR yog 64.6%, PFS nruab nrab yog 9.7 lub hlis (95% CI: 5.9–11.6), thiab DoR nruab nrab yog 9.6 lub hlis. Rau 41 tus neeg mob uas muaj CNS lesion uas tuaj yeem ntsuas tau, CNS-ORR uas tau lees paub yog 56.1% thiab CNS-PFS nruab nrab yog 10.6 lub hlis.

Hauv kev teeb tsa kev nyab xeeb, 289 tus neeg mob (96.0%) tau ntsib tsawg kawg ib qho kev tshwm sim tsis zoo ntsig txog kev kho mob (TRAE), nrog rau feem ntau yog raws plab (81.7%), ntshav tsis txaus (32.6%), pob khaus (29.9%), thiab anorexia (28.2%). Qib ≥3 TRAEs tau tshwm sim hauv 104 tus neeg mob (34.6%), nrog rau feem ntau suav nrog raws plab (13.0%), hypokalemia (4.3%), ntshav tsis txaus (4.0%), thiab pob khaus (3.3%). TRAEs ua rau kev cuam tshuam koob tshuaj thiab kev txiav koob tshuaj tau tshwm sim hauv 24.6% thiab 2% ntawm cov neeg mob, raws li. Tsis muaj TRAE ua rau tuag tau tshwm sim.

Cov Lus Xaus

Limertinib (ASK120067) tau pom tias muaj kev ua tau zoo thiab muaj kev nyab xeeb rau kev kho mob rau cov neeg mob uas muaj EGFR T790M-mutated NSCLC uas tau kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw.

Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

Xov Tooj: 4008803716

Email：myimmnet@163.com

Cov ntaub ntawv siv los ua piv txwv

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 thiab ASK Pharm Tshaj Tawm Ua Ke NMPA Kev Pom Zoo rau Limertinib, ib tiam thib peb EGFR TKI rau Kev Kho Mob Cancer Ntsws (prnewswire.com)

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