Iarratas trialach cliniciúil ríthábhachtach le haghaidh lorlatinib in ailse scamhóg chun cinn neamh-bheag cille ROS1-dearfach ceadaithe sa tSín

Ar 4 Eanáir, d'fhógair an chuideachta nuálaíoch cógaisíochta atá bunaithe i Hong Cong, CStone Pharmaceuticals (02616.HK) go bhfuil an t-iarratas ar thriail chliniciúil (IND) de lorlatinib le haghaidh ailse scamhóg chun cinn neamh-bheag cille (NSCLC) ROS1-dearfach ceadaithe ag an Náisiúnta. Riarachán Táirgí Leighis na Síne. Údarás (NMPA) ceadaithe. Is é seo an chéad staidéar lárnach ar domhan&ar lorlatinib i NSCLC ROS1-dearfach.

Tuigtear go bhfuil sé mar aidhm ag an staidéar meastóireacht a dhéanamh ar ghníomhaíocht antitumor agus sábháilteacht lorlatinib in othair le NSCLC chun cinn ROS1-dearfach, agus go gcláróidh sé othair le NSCLC chun cinn ROS1-dearfach ar theip orthu ceimiteiripe agus teiripe cruinneas. Is é críochphointe príomhúil an staidéir athbhreithniú neamhspleách ar ráta oibiachtúil freagartha (ORR) arna mheasúnú ag an gCoiste.

Léiríonn staitisticí go ndéantar níos mó ná 670,000 cás NSCLC a dhiagnóisiú sa tSín gach bliain, a bhfuil thart ar 2% -3% díobh de bharr athshocrú géine ROS1, le scála de thart ar 20,000 duine. Is adenocarcinomas scamhóg óg, neamh-tobac nó tobac a chaitheamh éadrom an chuid is mó díobh. in othair. Mar choscóir tyrosine kinase tríú glúin ALK/ROS1, féadfaidh lorlatinib rogha cóireála nua a sholáthar d'othair a bhfuil ailse scamhóg ardchealla neamh-bheag acu ROS1-dearfach.

Lorlatinib is a third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) with potent and selective inhibitory activity and is able to penetrate the blood-brain barrier. With its excellent clinical data, lorlatinib has been approved in more than 50 countries worldwide for the treatment of adult patients with ALK-positive metastatic NSCLC. In a previous phase I/II study, lorlatinib improved both ORR and intracranial ORR in TKI-naïve or TKI-failed patients with ROS1-positive advanced NSCLC. For patients with positive brain metastases, lorlatinib achieved high response rates and durable response times.

In this regard, Dr. Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said that there is currently no effective treatment for ROS1-positive NSCLC patients after they develop drug resistance. "We are delighted that lorlatinib has been approved for pivotal studies in patients with ROS1-positive NSCLC in China. We will accelerate the clinical study of lorlatinib and bring more treatment options to patients as soon as possible."

Is fiú a thabhairt faoi deara gur doimhniú breise é an staidéar seo ar an gcomhar straitéiseach idir CStone agus Pfizer. I mí Mheán Fómhair 2020, chuaigh CStone agus Pfizer isteach i gcomhar straitéiseach, a chuimsíonn creat comhair don dá pháirtí níos mó táirgí oinceolaíochta a thabhairt isteach i réigiún Mhórcheantar na Síne. I mí an Mheithimh 2021, d'fhógair CStone agus Pfizer go comhpháirteach go bhforbróidh an dá pháirtí lorlatinib i réigiún Mhórcheantar na Síne i gcomhpháirt agus go ndéanfaidh siad taighde ar NSCLC ROS1-dearfach, ag tabhairt roghanna cóireála níos mó d'fhormhór na n-othar i réimse na hailse.

The approval of lorlatinib for pivotal clinical studies is another piece of good news recently obtained by CStone. At the end of last month, the potential best-in-class PD-L1 antibody drug Zejiemei? (Sugalimumab injection) was approved by NMPA for marketing, and the clinical trial application of the potential best-in-class drug CS5001 (ROR1 ADC) in the world was approved by FDA for clinical research. CStone's advantages in precision therapy and immunotherapy are further highlighted.