Cemiplimab 350mg/7ml solution for infusion vials

BackgroundNon-small cell lung cancer (NSCLC) represents a significant challenge in oncology, characterized by its heterogeneous nature and poor prognosis, particularly in advanced stages. This study aimed to evaluate the efficacy of cemiplimab, administered intravenously at a dose of 350 mg every three weeks, in patients with advanced NSCLC, specifically focusing on its impact on prognostic biomarkers.MethodsFollowing PRISMA guidelines, we systematically searched Web of Science, PubMed, EMBASE, and Cochrane Library from inception to 31 May 2026. We included randomized controlled trials (RCTs) evaluating intravenous cemiplimab (350 mg every three weeks) in adult patients with advanced NSCLC. Comparators were placebo or standard of care. Eligible studies reported overall survival (OS), progression-free survival (PFS), or objective response rate (ORR). Two reviewers independently screened records, extracted data, and assessed risk of bias using the RoB2 tool. A random-effects meta-analysis was performed to pool risk ratios (RR) for response outcomes, with heterogeneity evaluated using I2 statistics. Publication bias was examined via funnel plots and Egger's test.ResultsAmong the eight studies reviewed, significant survival benefits were observed in OS and PFS for patients receiving cemiplimab treatment. Notably, patients without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) alterations demonstrated superior efficacy, particularly those with programmed cell death ligand 1 (PD-L1) expression levels ≥50%. The RR reported by Gogishvili et al. [2022] at 1.9 [95% confidence interval (CI): 1.39-2.62], Baramidze et al. [2024] at 2.11 (95% CI: 1.45-3.06), and Ricciuti et al. [2024] at 1.5 (95% CI: 1.22-1.84) underscore the consistency of cemiplimab's therapeutic effects across studies. Furthermore, five studies (71.4%) were classified as having low risk of bias, indicating robust methodological quality and enhancing confidence in the reported outcomes. Sensitivity analysis revealed an increased treatment effect (RR: 1.98788; 95% CI: 1.04653-3.77596; P=0.047) upon removal of Ricciuti et al. [2024], suggesting its significant influence on the overall effect size.ConclusionsThese findings advocate for cemiplimab as a viable treatment option in advanced NSCLC, warranting further investigations to elucidate its mechanisms and optimize treatment strategies for diverse patient populations.

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BackgroundImmune checkpoint inhibitors (ICIs) are the standard first-line care for advanced non-small cell lung cancer (NSCLC). However, optimal therapeutic choices for patients with brain metastases remain unclear due to a lack of direct comparisons. We conducted a systematic review and Bayesian network meta-analysis to evaluate the comparative efficacy of first-line ICI regimens stratified by brain metastasis status.MethodsWe searched PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) of first-line ICI regimens in advanced NSCLC. We performed a Bayesian network meta-analysis to estimate hazard ratios (HRs) and 95% credible intervals (CrIs) for overall survival (OS) and progression-free survival (PFS). Models were stratified by brain metastasis status to rank treatment efficacy using the CINeMA system for quality assessment. The protocol is registered with PROSPERO (CRD420251236228).ResultsWe synthesized data from 12 RCTs (n=7, 122) evaluating 14 ICI regimens. In patients with brain metastases, ICI plus chemotherapy significantly improved OS versus chemotherapy alone (HR = 0.57; 95% CrI: 0.45-0.72), while both monotherapy (HR = 0.50; 95% CrI: 0.30-0.85) and combination therapy (HR = 0.42; 95% CrI: 0.31-0.55) prolonged PFS. For patients without brain metastases, both strategies yielded superior OS and PFS. Bayesian ranking indicated that for brain metastases, cemiplimab plus chemotherapy conferred the greatest OS benefit (HR = 0.29; 95% CrI: 0.11-0.76; rank 1 probability: 41.66%). Regarding PFS in this subgroup, sugemalimab plus chemotherapy showed the strongest relative effect (HR = 0.30; 95% CrI: 0.15-0.59), whereas camrelizumab plus chemotherapy achieved the highest probability of ranking first (35.85%). In the non-brain metastasis cohort, pembrolizumab plus chemotherapy (HR = 0.58; 95% CrI: 0.46-0.73) and sintilimab plus chemotherapy (HR = 0.49; 95% CrI: 0.37-0.64) were the leading regimens for OS and PFS, respectively.ConclusionsICI plus chemotherapy provides a survival advantage over chemotherapy alone in advanced NSCLC, irrespective of brain metastasis status. Bayesian rankings favor cemiplimab, sugemalimab, or camrelizumab plus chemotherapy for patients with brain metastases, and pembrolizumab or sintilimab plus chemotherapy for those without. These findings, currently limited by low-certainty indirect evidence, warrant validation in adequately powered, head-to-head trials.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD420251236228.

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BackgroundCutaneous squamous-cell carcinoma (cSCC) is cured with surgery with or without radiotherapy in most cases, but patients with high-risk features remain prone to recurrence. Until recently, no systemic adjuvant therapy was available. Recently, two phase III trials assessed post-operative anti-programmed cell death protein 1 (PD-1): C-POST (cemiplimab), which met its primary endpoint, and KEYNOTE-630 (pembrolizumab), which did not.MethodsWe compared the eligibility criteria and risk definitions of both trials. Published disease-free survival (DFS) curves were digitized, and individual patient data (IPD) were reconstructed with validated algorithms. DFS was analyzed using Kaplan-Meier estimates, log-rank tests, Cox models, and restricted mean survival time. Subgroup analyses considered nodal high-risk patients in the two studies. Hazard ratios (HRs) informed a meta-analysis with the generic inverse variance method.ResultsThe placebo arms showed no DFS difference. Although no direct comparisons can be made across trials and in spite of the different eligibility criteria of the two studies, cemiplimab achieved superior DFS versus pembrolizumab. Pooling experimental arms confirmed a DFS benefit with PD-1 therapy [HR 0.53, 95% confidence interval (CI) 0.40-0.71]. Cemiplimab (HR 0.36) and pembrolizumab (HR 0.44) consistently reduced recurrence risk in nodal high-risk patients, yielding a combined HR of 0.40 (95% CI 0.26-0.62) with no heterogeneity.ConclusionAdjuvant PD-1 blockade significantly improves DFS in high-risk cSCC. With the caveats of indirect comparisons and the pending full publication of one of the two trials, these post hoc findings are hypothesis generating and may help inform the selection of high-risk patients deserving adjuvant therapy.

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