I-Limertinib Ithole Imvume EShayina Ye-EGFR T790M+ NSCLC

Ngomhlaka-16 Januwari 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) ye-limertinib yokwelapha iziguli ezindala ezine-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ethuthukisiwe noma esakazeke endaweni.

Mayelana ne-Limertinib

I-Limertinib iyi-EGFR TKI yesizukulwane sesithathu enikezwa ngomlomo, enamalungelo obunikazi, evunyiwe yi-NMPA yaseShayina yokwelapha iziguli ezindala ezine-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ethuthukisiwe noma eguquliwe endaweni ethile. I-NDA yesibili ingaphansi kokubuyekezwa kwe-NMPA yokwelashwa kokuqala kweziguli ezindala ezine-NSCLC ethuthukisiwe noma eguquliwe endaweni ethile ene-EGFR exon 19 deletions noma i-exon 21 L858R mutations.

Lo muthi ubonise impumelelo esivivinyweni somtholampilo seSigaba sesi-3 esinezikhungo eziningi, esingahleliwe, esingaboni kabili, esilawulwayo esiqhathanisa ukusebenza kahle nokuphepha kwawo kwe-gefitinib ekwelashweni kokuqala kweziguli ezine-NSCLC ethuthukisiwe noma esakazeke kakhulu enezinguquko ze-EGFR. Uma isiphetho esiyinhloko sifinyelelwe, imiphumela izokwethulwa emihlanganweni yezemfundo ezayo noma ishicilelwe kumajenali ezemfundo.

Isinqumo sokulawula sisekelwe yidatha evela esivivinyweni esibalulekile sesigaba sesi-2b (NCT03502850), Lolu ucwaningo lwesigaba sesi-2b olunengalo eyodwa, oluvulekile, olwenziwe ezibhedlela ezingu-62 kulo lonke elase-People's Republic of China. Iziguli ezine-NSCLC ethuthukisiwe noma esakazeke kakhulu endaweni enezinguquko ze-EGFR T790M eziqinisekisiwe phakathi nendawo ezicutshini zesimila noma i-plasma yegazi ezathuthuka ngemuva kokubhaliswa kwe-EGFR tyrosine kinase inhibitors yesizukulwane sokuqala noma sesibili noma ezinezinguquko ze-EGFR T790M eziyinhloko.

Kusukela ngoJulayi 16, 2019, kuya kuMashi 10, 2021, iziguli ezingu-301 zabhaliswa futhi zaqala ukwelashwa nge-limertinib. Zonke iziguli zangena kusethi ephelele yokuhlaziya kanye nesethi yokuphepha. Ngosuku lokuphelelwa kwedatha ngoSepthemba 9, 2021, abangu-76 (25.2%) basala bethola ukwelashwa. Isikhathi sokulandelela esimaphakathi sasiyizinyanga ezingu-10.4. Ngokusekelwe kusethi ephelele yokuhlaziya, i-ORR ehlolwe yikomidi elizimele lokubuyekeza yayingama-68.8% kanti izinga lokulawula izifo lalingama-92.4%. I-PFS emaphakathi yayingama-11.0 izinyanga, i-DoR emaphakathi yayingama-11.1 izinyanga, kanti i-OS emaphakathi ayizange ifinyelelwe. Izimpendulo zenhloso zafezwa kuwo wonke amaqembu amancane achazwe kusengaphambili. Ezigulini ezingu-99 (32.9%) ezine-metastases yesistimu yezinzwa ephakathi (CNS), i-ORR yayingu-64.6%, i-PFS ephakathi yayiyizinyanga ezingu-9.7 (95% CI: 5.9–11.6), kanti i-DoR ephakathi yayiyizinyanga ezingu-9.6. Ezigulini ezingu-41 ezazine-CNS lesion ehlolwayo, i-CNS-ORR eqinisekisiwe yayingu-56.1% kanti i-CNS-PFS ephakathi yayiyizinyanga ezingu-10.6.

Ngokwesethi yokuphepha, iziguli ezingu-289 (96.0%) zithole okungenani isenzakalo esisodwa esibi esihlobene nokwelashwa (i-TRAE), esivame kakhulu kube isifo sohudo (81.7%), i-anemia (32.6%), ukuqubuka (29.9%), kanye ne-anorexia (28.2%). Ibanga ≥3 Ama-TRAE enzeka ezigulini ezingu-104 (34.6%), kanti esivame kakhulu sihlanganisa isifo sohudo (13.0%), i-hypokalemia (4.3%), i-anemia (4.0%), kanye nokuqubuka (3.3%). Ama-TRAE aholela ekuphazamisekeni komthamo kanye nokuyekiswa komthamo kwenzeke kuziguli ezingu-24.6% kanye no-2% ngokulandelana. Akukho TRAE eholele ekufeni okwenzekayo.

Iziphetho

I-Limertinib (ASK120067) itholakale inamandla athembisayo kanye nephrofayili yokuphepha eyamukelekayo ekwelapheni iziguli ezine-NSCLC eguquliwe ye-EGFR T790M endaweni noma eguquliwe.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

1.国家药品监督管理局 (nmpa.gov.cn)

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

3.I-Innovent ne-ASK Pharm Bamemezela Ngokubambisana Ukuvunyelwa kwe-NMPA kwe-Limertinib, i-EGFR TKI yesizukulwane sesithathu yokwelapha umdlavuza wamaphaphu (prnewswire.com)

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