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On July 23, the official website of CDE showed that Betta Pharmaceuticals' new indications for the new indications of Ensatinib, an ALK inhibitor, are planned to be reviewed as the first-line treatment for ALK-positive NSCLC
Ensatinib Hydrochloride (X-396) is a new molecular entity compound with completely independent intellectual property rights jointly developed by Betta Pharmaceuticals and its subsidiary Xcovery Holdings, Inc.
In December 2018, Betta submitted its first listing application for Ensatinib.
At the WCLC Presidential Symposium in August 2020, the global multicenter phase III clinical (eXalt3) results of Ensatinib for the first-line treatment of ALK-positive NSCLC patients were announced for the first time
eXalt3 is a randomized, open-label, global multicenter phase 3 clinical trial that includes patients with stage IIIB/IV NSCLC who have not previously received treatment, and they are divided 1:1 into the Ensatinib group and the Crizotinib group
The results showed that among the 290 ALK-positive NSCLC patients enrolled, the complete remission rate of ensatinib was 14% (vs crizotinib 6%), and the total effective rate was 75% (vs crizotinib 67%) ), the median PFS was 25.
From: WCLC Presidential Symposium
After that, Betta updated the data again
From: 2020WCLC
In the previous Betta 2020 performance meeting, Betta stated that it will advance the preparations for the Sino-US dual report of Ensatinib based on the positive results of the global phase 3 clinical eXalt3.
