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▎Clinical problems:
The efficacy and safety of trepilimab in combination with chemotherapy as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) is unclear
.
A study from J Clin Oncol showed that trepilimab combined with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS)
in patients with late-treatment-naïve NSCLC.
▎Research protocol:
Patients with treatment-new, late-stage NSCLC (N=465) without EGFR/ALK mutations were randomized 2:1 to receive 240 mg of trepilimab (n=309) or placebo (n=156) every 3 weeks, in combination with chemotherapy for 4 to 6 cycles, followed by teruplimab or placebo maintenance therapy every 3 weeks plus standard care
.
Stratifying factors included ligand-1 expression status, histology, and smoking status
.
The primary endpoint was PFS
as determined by the investigators based on RECIST v1.
1.
Secondary endpoints included OS and security
.
▎Key findings:
1) At the time of final PFS analysis, PFS was significantly longer in the trepilimab treatment group compared with the placebo group (median PFS 8.
4 vs 5.
6 months, HR = 0.
49, 95% CI 0.
39-0.
61; bilateral P<0.
0001).
<b20>
2) At the time of interim OS analysis, OS was significantly longer in the trepilimab treatment group compared with the placebo group (median OS did not reach vs 17.
1 months, HR = 0.
69, 95% CI 0.
53-0.
92; bilateral P=0.
0099).
3) The incidence of grade 3 adverse events ≥ similar
in both groups.
Treatment effect was similar
regardless of the status of programmed death ligand-1.
4) Genome analysis of whole exome sequencing of 394 tumor samples showed that PFS was significantly prolonged in patients with high tumor mutation burden in the trepilimab treatment group (median PFS 13.
1 vs 5.
5 months, P=0.
026).
5) Patients with mutations in the PI3K-Akt signaling pathway received significantly better PFS and OS (P≤0.
001)
in the trepilimab treatment group.
▎Outlook:
Trepilimab combined with chemotherapy can significantly improve PFS and OS in patients with treatment-naïve advanced NSCLC, and its drug safety is controllable
.
References: [1] https://ascopubs.
org/doi/full/10.
1200/JCO.
22.
00727
of clinical literature Top Journal Essentials Assistant is online 👇
1.
Scan the QR code below to jump to "Top Journal Essentials.
" H5 page
2.
Click "Download Now"
3.
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J Clin Oncol: Trepilimab in combination with chemotherapy significantly improves PFS and OS in patients with treatment-naïve advanced non-small cell lung cancer
▎Clinical problems:
The efficacy and safety of trepilimab in combination with chemotherapy as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) is unclear
.
A study from J Clin Oncol showed that trepilimab combined with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS)
in patients with late-treatment-naïve NSCLC.
▎Research protocol:
Patients with treatment-new, late-stage NSCLC (N=465) without EGFR/ALK mutations were randomized 2:1 to receive 240 mg of trepilimab (n=309) or placebo (n=156) every 3 weeks, in combination with chemotherapy for 4 to 6 cycles, followed by teruplimab or placebo maintenance therapy every 3 weeks plus standard care
.
Stratifying factors included ligand-1 expression status, histology, and smoking status
.
The primary endpoint was PFS
as determined by the investigators based on RECIST v1.
1.
Secondary endpoints included OS and security
.
▎Key findings:
1) At the time of final PFS analysis, PFS was significantly longer in the trepilimab treatment group compared with the placebo group (median PFS 8.
4 vs 5.
6 months, HR = 0.
49, 95% CI 0.
39-0.
61; bilateral P<0.
0001).
<b20>
2) At the time of interim OS analysis, OS was significantly longer in the trepilimab treatment group compared with the placebo group (median OS did not reach vs 17.
1 months, HR = 0.
69, 95% CI 0.
53-0.
92; bilateral P=0.
0099).
3) The incidence of grade 3 adverse events ≥ similar
in both groups.
Treatment effect was similar
regardless of the status of programmed death ligand-1.
4) Genome analysis of whole exome sequencing of 394 tumor samples showed that PFS was significantly prolonged in patients with high tumor mutation burden in the trepilimab treatment group (median PFS 13.
1 vs 5.
5 months, P=0.
026).
5) Patients with mutations in the PI3K-Akt signaling pathway received significantly better PFS and OS (P≤0.
001)
in the trepilimab treatment group.
▎Outlook:
Trepilimab combined with chemotherapy can significantly improve PFS and OS in patients with treatment-naïve advanced NSCLC, and its drug safety is controllable
.
References: [1] https://ascopubs.
org/doi/full/10.
1200/JCO.
22.
00727
of clinical literature Top Journal Essentials Assistant is online 👇
1.
Scan the QR code below to jump to "Top Journal Essentials.
" H5 page
2.
Click "Download Now"
3.
Open the Doctor Station App and click the column
4.
Find the "top journal essentials" in clinical medication
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