I-Limertinib Iphumelele Imvume E-China Ye-EGFR T790M+ NSCLC

Ngomhla we-16 kweyoMqungu, ngowama-2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile isicelo esitsha se-limertinib (NDA) sokunyanga izigulane zabantu abadala ezine-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ephucukileyo okanye eguqukileyo.

Malunga neLimertinib

I-Limertinib yi-EGFR TKI yesizukulwana sesithathu elawulwa ngomlomo, enamalungelo obunini, evunyiwe yi-NMPA yaseTshayina yokunyanga izigulane zabantu abadala abane-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ephuculweyo okanye eguquliweyo. I-NDA yesibini iphantsi kovavanyo lwe-NMPA lokunyanga izigulane zabantu abadala abane-NSCLC ephuculweyo okanye eguquliweyo ephethe i-EGFR exon 19 deletions okanye i-exon 21 L858R mutations.

Eli yeza libonakalise impumelelo kuvavanyo lweklinikhi lweSigaba sesi-3 oluneziko ezininzi, olucwangcisiweyo, olungaboni kabini, olulawulwayo oluthelekisa ukusebenza kwalo kunye nokhuseleko lwe-gefitinib kunyango lokuqala lwezigulane ezine-NSCLC ephucukileyo okanye eguqukileyo egcina i-EGFR mutations. Xa isiphelo sokuqala sifezekisiwe, iziphumo ziya kuboniswa kwiingqungquthela zemfundo ezizayo okanye zipapashwe kwiijenali zemfundo.

Isigqibo solawulo sixhaswe yidatha evela kuvavanyo olubalulekileyo lwesigaba sesi-2b (NCT03502850), Olu luphononongo lwesigaba sesi-2b olunengalo enye, oluvulelekileyo, olwenziwe kwizibhedlele ezingama-62 kulo lonke iRiphabliki yaseTshayina. Izigulane ezine-NSCLC ephucukileyo okanye eguqukileyo ene-EGFR T790M mutations eqinisekisiweyo phakathi kwizicubu zethumba okanye kwiplasma yegazi ezaqhubekeka emva kokuba i-EGFR tyrosine kinase inhibitors yesizukulwana sokuqala okanye sesibini okanye ezine-EGFR T790M mutations eziphambili zibhalisiwe.

Ukususela nge-16 kaJulayi 2019, ukuya kwi-10 kaMatshi 2021, izigulane ezingama-301 zizonke zabhaliswa zaza zaqala unyango lwe-limertinib. Zonke izigulane zingene kwiseti epheleleyo yohlalutyo kunye neseti yokhuseleko. Ngomhla wokuphela kwedatha nge-9 kaSeptemba 2021, ama-76 (25.2%) ahlala kunyango. Ixesha eliphakathi lokulandelela yayiziinyanga ezili-10.4. Ngokusekelwe kwiseti epheleleyo yohlalutyo, ikomiti yokuhlaziya ezimeleyo ehlolwe yi-ORR yayiyi-68.8% kwaye izinga lokulawula izifo yayiyi-92.4%. I-PFS ephakathi yayiziinyanga ezili-11.0, i-DoR ephakathi yayiziinyanga ezili-11.1, kwaye i-OS ephakathi ayizange ifikelelwe. Iimpendulo zeenjongo zifezekisiwe kuwo onke amaqela amancinci achazwe kwangaphambili. Kwizigulane ezingama-99 (32.9%) ezine-metastases yenkqubo ye-nervous system (CNS), i-ORR yayiyi-64.6%, i-PFS ephakathi yayiyi-9.7 iinyanga (95% CI: 5.9–11.6), kwaye i-DoR ephakathi yayiyi-9.6 iinyanga. Kwizigulane ezingama-41 ezazine-CNS lesion evavanywayo, i-CNS-ORR eqinisekisiweyo yayiyi-56.1% kwaye i-CNS-PFS ephakathi yayiyi-10.6 iinyanga.

Kwiseti yokhuseleko, izigulane ezingama-289 (96.0%) zenze ubuncinci isiganeko esinye esibi esinxulumene nonyango (TRAE), apho esona sixhaphakileyo sisirhudo (81.7%), i-anemia (32.6%), irhashalala (29.9%), kunye ne-anorexia (28.2%). Ii-TRAE zebanga ≥3 zenzeke kwizigulane ezili-104 (34.6%), apho ezona zixhaphakileyo ziquka irhashalala (13.0%), i-hypokalemia (4.3%), i-anemia (4.0%), kunye nerhashalala (3.3%). Ii-TRAE ezikhokelela ekuphazamisekeni kwedosi kunye nokuyeka idosi zenzeke kwizigulane ezingama-24.6% kunye nezi-2% ngokwahlukeneyo. Akukho TRAE ekhokelele ekufeni.

Izigqibo

I-Limertinib (ASK120067) ifunyenwe inamandla athembisayo kunye neprofayili yokhuseleko eyamkelekileyo kunyango lwezigulane ezine-NSCLC ye-EGFR T790M eguquliweyo okanye eguquliweyo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

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.I-Innovent kunye ne-ASK Pharm zibhengeza ngokudibeneyo ukuVunywa kwe-NMPA kwe-Limertinib, i-EGFR TKI yesizukulwana sesithathu yoNyango loMhlaza weMiphunga (prnewswire.com)

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