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In patients with advanced epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer ( NSCLC ), acquired EGFR T790M mutation is responsible for the development of resistance after treatment with first- or second-generation tyrosine kinase inhibitors (TKIs) The most common cause of sex
.
Recent research has focused on identifying third-generation drugs that can selectively inhibit EGFR and T790M resistance mutations without inhibiting wild-type receptors
Lung cancer diagnosis and management of NSCLC
The primary endpoints of the study were safety and objective response rate (ORR)
.
Secondary endpoints included progression-free survival, overall survival, and intracranial ORR
The study included 78 patients who received lazertinib 240 mg, 76 of whom were T790M mutation-positive
Among T790M-positive patients (76, confirmed by tissue center), 1 (1.
Efficacy assessment
Efficacy assessmentAt data cutoff, 49 of 76 patients (64.
5%) progressed or died after a median follow-up of 20.
8 months (interquartile range [IQR], 17.
7 to 28.
8)
.
The median progression-free survival was 11.
At data cutoff, 49 of 76 patients (64.
PFS
PFSAfter a median follow-up of 22.
0 months, the median overall survival was not reached (IQR, 15.
4 to 28.
3)
.
Overall survival at 12 and 24 months was 89.
After a median follow-up of 22.
OS
OSThe confirmed intracranial ORR was 85.
7% (95% CI, 59.
8 100.
0%), and the intracranial disease control rate was 100.
0% (95% CI, 100.
0 100.
0%)
.
The median duration of intracranial response was 15.
The confirmed intracranial ORR was 85.
Intracranial PFS
Intracranial PFSThe most common treatment-acute adverse events were rash (37.
2%), pruritus (34.
6%), and paresthesia (33.
3%); most patients had mild to moderate disease
.
Serious drug-related adverse events (gastritis, pneumonia, pneumonitis) occurred in 3 patients
.
In conclusion, the study demonstrated that lazertinib 240 mg/day has a manageable safety profile and durable antitumor efficacy (including brain metastases) in patients with advanced T790m-positive NSCLC who have progressed on prior EGFR TKI therapy
.
.
The study demonstrated that lazertinib 240 mg/day had a manageable safety profile and durable antitumor efficacy (including brain metastases) in patients with advanced T790m-positive NSCLC who had progressed on prior EGFR TKI therapy
.
Original source:
Original source:Cho BC, Han JY, Kim SW, Lee KH, Cho EK, Lee YG, Kim DW, Kim JH, Lee GW, Lee JS, Shim BY, Kim JS, Chun SH, Lee SS, Kim HR, Hong MH, Ahn JS , Sun JM, Lee Y, Lee DH, Kang JA, Lee N, Kwon MJ, Espenschied C, Yablonovitch A, Ahn MJ.
A Phase 1/2 Study of Lazertinib 240 mg in Patients with Advanced EGFR T790M-Positive Non-Small Cell Lung Cancer After Prior EGFR Tyrosine Kinase Inhibitors.
J Thorac Oncol.
2021 Dec 24:S1556-0864(21)03403-1.
doi: 10.
1016/j.
jtho.
2021.
11.
025.
Epub ahead of print.
PMID: 34958928.