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Recently, Professor Wu Yilong and Professor Leora Horn from Guangdong Provincial People’s Hospital , as co-corresponding authors , published a Phase III randomized clinical trial on the efficacy and safety of Ensatinib vs.
Recently, Professor Wu Yilong and Professor Leora Horn from Guangdong Provincial People’s Hospital , as co-corresponding authors , published a Phase III randomized clinical trial on the efficacy and safety of Ensatinib vs.
This is an open-label, multi-center, randomized phase III clinical study conducted in 120 centers in 21 countries around the world
This is an open-label, multi-center, randomized phase III clinical study conducted in 120 centers in 21 countries around the world
From July 25, 2015 to November 12, 2018, a total of 290 patients were enrolled, including 143 cases of Ensatinib and 147 cases of Crizotinib
As of July 1, 2020, the overall intent population (ITT, n=290) mPFS in the ensatinib group was better than that in the crizotinib group, which were 25.
The objective response rate (ORR) was 74% (95% CI, 66%-81%) in the Ensatinib group and 67% (95% CI, 58%-74%) in the Crizotinib group
In the revised intention population (mITT of ALK-positive patients confirmed by the central laboratory, n=247 cases, of which 121 cases of Ensatinib
PFS in mITT population
Among patients without brain metastases in the mITT population, the median PFS of the Ensatinib group and the crizotinib group were NR (25.
Among patients without brain metastases in the mITT population, the median PFS of the Ensatinib group and the crizotinib group were NR (25.
PFS in mITT population without brain metastasis
The median OS of the two groups was not reached, and the 2-year OS rates were 78% (95% CI, 69%-84%) and 78% (95% CI, 70%-85%), respectively
The median OS of the two groups was not reached, and the 2-year OS rates were 78% (95% CI, 69%-84%) and 78% (95% CI, 70%-85%), respectively
OS in mITT population
Incidence of treatment-related serious adverse events (Ensatinib: 7.
7% vs Crizotinib: 6.
1%), dose reduction (Ensatinib: 23.
8% vs Crizotinib: 19.
9%) or withdrawal (Ensatinib: 23.
8% vs Crizotinib: 19.
9%) Satinib: 9.
1% vs Crizotinib: 6.
8%) Similar
.
7% vs Crizotinib: 6.
1%), dose reduction (Ensatinib: 23.
8% vs Crizotinib: 19.
9%) or withdrawal (Ensatinib: 23.
8% vs Crizotinib: 19.
9%) Satinib: 9.
1% vs Crizotinib: 6.
8%) Similar
.
In summary, the study shows that Ensatinib is better than crizotinib and can be used as a first-line treatment for ALK-positive NSCLC patients
.
.
This study shows that Ensatinib is better than Crizotinib and can be used as the first-line treatment for ALK-positive NSCLC patients
.
This study shows that Ensatinib is better than Crizotinib and can be used as the first-line treatment for ALK-positive NSCLC patients
.
NSCLC
Original source:
Original source:Horn L, Wang Z, Wu G, et al.
Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial.
JAMA Oncol.
2021 Sep 2.
doi: 10.
1001/jamaoncol.
2021.
3523.
Epub ahead of print.
PMID: 34473194.
Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial.
JAMA Oncol.
2021 Sep 2.
doi: 10.
1001/jamaoncol.
2021.
3523.
Epub ahead of print.
PMID: 34473194.
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