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Review
. 2025 Apr 25;87(6):3800-3809.
doi: 10.1097/MS9.0000000000003329. eCollection 2025 Jun.

Safety, efficacy, and quality of life with cemiplimab treatment among non-small cell lung cancer patients: a systematic review and meta-analysis

Abhay Mane  1 , Rukesh Yadav  2
Affiliations
Review

Safety, efficacy, and quality of life with cemiplimab treatment among non-small cell lung cancer patients: a systematic review and meta-analysis

Abhay Mane et al. Ann Med Surg (Lond). .

Abstract

Background: Immune checkpoint inhibitors have shown promise in treating advanced non-small cell lung cancer and have a solid safety profile. Cemiplimab can be used as monotherapy or in combination with chemotherapy for both squamous and non-squamous cancers. We opted for a systematic review and meta-analysis to find out the efficacy outcome and safety profile along with quality-of-life data of cemiplimab for advanced non-small-cell lung cancer (NSCLC).

Methods: A rigorous search of literature on PubMed, Embase, and Google Scholar was done to find relevant published publications till December 1, 2023. Outcomes like objective response rate (ORR), overall survival (OS), progression-free survival (PFS), common side effects, and quality of life among the cemiplimab and the control group were used to conduct meta-analysis using the fixed/random effect model for combined odds ratio (OR), combined hazard ratio (HR) and mean difference at confidence interval (CI) of 95%.

Results: Two randomized clinical trials EMPOWER 1 and EMPOWER 3 with 1092 advanced NSCLC patients along with their follow-up studies were included. There was significantly higher OS (HR = 0.62 [0.54, 0.70], P < 0.0001) and PFS (HR = 0.54 [0.48, 0.60], P < 0.0001] in the treatment group. Similarly, the combined ORR was significantly higher in the treatment group as compared to the control group (2.63 [95% CI: 2.17-3.20, P ≤ 0.001]). Treatment-emergent adverse effects were not different between the groups. Finally, the quality-of-life scores between the two groups were nonsignificant.

Conclusion: With regard to OS, PFS, ORR, quality of life scores, and an acceptable safety profile in advanced non-small cell lung cancer, cemiplimab showed clinically relevant and statistically significant improvements making it standard of care for such patients.

Keywords: cemiplimab; chemotherapy; non-small cell lung cancer.

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Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. None to be disclosed by any author.

Figures

Figure 1.
Figure 1.
PRISMA diagram showing the selection process and final included studies.
Figure 2.
Figure 2.
Risk of bias summary: review authors’ judgments about each risk of bias item for each included trial (EMPOWER 1 and EMPOWER 3).
Figure 3.
Figure 3.
Forest plot showing pooled hazard ratio with 95% CI for OS.
Figure 4.
Figure 4.
Forest plot showing pooled hazard ratio with 95% CI for PFS.
Figure 5.
Figure 5.
Forest plot showing pooled odds ratio with 95% CI for ORR.
Figure 6.
Figure 6.
Forest plot showing pooled odds ratio with 95% CI for CR.
Figure 7.
Figure 7.
Forest plot showing pooled odds ratio with 95% CI for PR.
Figure 8.
Figure 8.
Forest plot showing pooled odds ratio with 95% CI for SD.
Figure 9.
Figure 9.
Forest plot showing pooled odds ratio with 95% CI for PD.
Figure 10.
Figure 10.
Forest plot showing pooled odds ratio with 95% CI for grade ≥3 TEAEs.
Figure 11.
Figure 11.
Forest plot showing pooled odds ratio with 95% CI for mortality.
Figure 12.
Figure 12.
Forest plot showing the mean difference with 95% CI for QLQ-C30 scores.
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