About the Trial
Trial Name: Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
ClinicalTrials.gov ID: NCT03409614
Sponsor: Regeneron Pharmaceuticals
Completion Date: February 27, 2025
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Cemiplimab With Chemotherapy Sustains OS at 5 Years for Patients With Advanced NSCLC
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Key Takeaways
- Cemiplimab combined with chemotherapy significantly improved overall survival in advanced NSCLC patients, with a median OS of 21.1 months versus 12.9 months for chemotherapy alone.
- The trial showed a 34% reduction in the risk of death with cemiplimab, with a 5-year survival probability of 19.4% compared to 8.8% for chemotherapy alone.
Cemiplimab was also superior in improving progression-free survival, objective response rate, and duration of response in patients with non–small cell lung cancer (NSCLC).
Researchers from Regeneron presented data showing that cemiplimab (Libtayo) alongside platinum-based chemotherapy sustained overall survival (OS) benefits at 5 years in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who had no EGFR, ALK, or ROS1 aberrations. The findings, which were from the phase 3 EMPOWER-Lung 3 trial (NCT03409614) and presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), showed that the cemiplimab combination regimen was superior to chemotherapy alone.1,2
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Cemiplimab is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells. By binding to it, cemiplimab has been previously shown to block cancer cells from utilizing that pathway to suppress T-cell activation. The agent has received approvals for certain adult patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, advanced NSCLC, and advanced cervical cancer.1
EMPOWER-Lung 3 is a randomized, multicenter phase 3 trial that investigated cemiplimab with platinum-doublet chemotherapy, compared with the latter alone, when treating patients within the first-line setting. The trial was 2 parts, and the primary objectives were to compare the OS of cemiplimab and chemotherapy compared with chemotherapy alone (part 1) and progression-free survival (PFS) and objective response rate (ORR; part 2), and key secondary end points were OS regardless of PD-L1 expression (part 1) and comparing the PFS and ORR in patients who had tumors expressing PD-L1 in less than 50% of tumor cells (part 2).1,2
Patients were randomly assigned to receive either 350 mg of cemiplimab (n = 312) or placebo (n = 154) administered intravenously every 3 weeks for a 108-week duration in addition to platinum-doublet chemotherapy administered every 3 weeks for 4 cycles.
Participating patients notably had a variety of baseline characteristics commonly considered “difficult-to-treat,” such as tumors with squamous histology (43%), tumors with less than 50% PD-L1 expression (67%), inoperable locally advanced disease not eligible for definitive chemoradiation (15%), and pretreated and clinically stable brain metastases (7%). Additionally, about 84% of patients had an ECOG 1 performance status.1,2
According to the findings, patients treated with the cemiplimab regimen achieved a superior median OS (21.1 months) compared with placebo and chemotherapy (12.9 months), representing a 34% reduction in the risk of death (hazard ratio [HR]: 0.66; 95% confidence interval [CI]: 0.53–0.83). The 5-year probability of survival was about 19.4% and 8.8% for these respective groups. Additionally, cemiplimab also demonstrated superior median PFS (8.2 months), ORR (43.6%), and median duration of response (DOR; 16.4 months) compared with chemotherapy (PFS: 5.5 months; ORR: 22.1%; DOR: 7.3 months). Notably, cemiplimab showed positive findings regardless of squamous histology and PD-L1 expression.1
The safety profile at 5 years remained consistent with previously reported data, according to a news release. The median duration of exposure was about 39 weeks to cemiplimab plus chemotherapy and 21 weeks to chemotherapy alone. Adverse events (AEs) of any grade had similar frequencies in both groups (cemiplimab: 96.5%; chemotherapy: 95%) and included anemia (46%), alopecia (38%), and nausea (25%), among others.1
“After more than 5 years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival—with an impressive overall survival probability of 19.4% at 5 years—when [cemiplimab] is added to chemotherapy in patients with advanced NSCLC,” Ana Baramidze, MD, PhD, head of clinical research department at Todua Clinic, Tbilisi, Georgia, said in a news release. “Long-term results across tumor histologies were also reported, including a notable 22.3-month median OS for [patients with squamous NSCLC]. Collectively, these data underscore [cemiplimab’s] utility across a variety of patient types, both as a single agent and in combination with chemotherapy.”1
REFERENCES
1. Regeneron. Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer. News release. September 9, 2025. Accessed September 16, 2025. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years
2. Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer. ClinicalTrials.gov identifier: NCT03409614. Updated March 13, 2025. Accessed September 16, 2025. https://clinicaltrials.gov/study/NCT03409614
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