Survival Outcomes in Advanced NSCLC Improved With Use of Cemiplimab

Durable and significant improvements in survival outcomes were seen at 5 years of follow-up among patients with non-small cell lung cancer (NSCLC) using cemiplimab plus chemotherapy, according to results presented during the World Conference on Lung Cancer, held in Barcelona, Spain, from September 6 to September 9, 2025.¹ The survival rate was more than double the rate of survival with chemotherapy alone.

These results came from the phase 3 EMPOWER-Lung 3 trial (NCT03409614) conducted in adults with locally advanced or metastatic NSCLC. These patients had no EGFR, ALK, or ROS1 aberrations. These data add to results presented at the World Conference on Lung Cancer in 2024 from the EMPOWER-Lung 1 trial, which found cemiplimab alone was an effective therapy for advanced NSCLC with survival benefits.

The initial results of the EMPOWER-Lung 3 trial were published in Nature Medicine in 2022.² There were 466 patients who had stage III or IV advanced NSCLC without any genomic tumor aberrations. Baseline characteristics of the participants indicated that they would be difficult to treat, with 43% having a tumor with squamous histology and 67% had tumors with PD-L1 expression lower than 30%. The participants were split 2:1 where 312 participants received cemiplimab 350 mg for up to 108 weeks with 4 cycles of platinum-doublet chemotherapy; 154 participants received a placebo with the platinum-doublet chemotherapy. The median overall survival (OS) was 21.9 months in those receiving cemiplimab compared with 13.0 months in those taking placebo with chemotherapy (HR, 0.71; 95% CI, 0.53-0.93).

The results presented in 2025 confirm the previous results after a median follow-up of 60.9 months.¹ The participants were consistent through the follow-up time, with data from all 466 original patients included in the follow-up results. OS remained strong in those taking cemiplimab with chemotherapy when compared with chemotherapy alone, with a 21.1-month median OS compared with 12.9 months, respectively (HR, 0.66; 95% CI, 0.53-0.83). Those who took cemiplimab with chemotherapy had a 19.4% probability of survival after 5 years compared with 8.8% in those receiving chemotherapy alone.

Progression-free survival (PFS) was also stronger in those taking cemiplimab. The median PFS was 8.2 months in those taking cemiplimab compared with a median of 5.5 months in those receiving chemotherapy alone (HR, 0.58; 95% CI, 0.47-0.72). Objective response rate was 43.6% in those taking cemiplimab compared with 22.1% for those on chemotherapy alone and the median duration of response was 16.4 months in those taking cemiplimab compared with 7.3 months in those receiving chemotherapy alone.

The safety profile was consistent with previous studies and 96.5% of those on cemiplimab experienced an adverse event of any grade compared with 95% in those on chemotherapy alone. The most common adverse events experienced by those on cemiplimab included anemia (46%), alopecia (38%), and nausea (25%) among others. A total of 30% of those taking cemiplimab had adverse events that were rated grade 3 or higher, which caused discontinuation in 4.5% of the population and death in 1% of the population; the chemotherapy arm had 18% who had grade 3 or higher adverse events, 1% of the patients discontinued, and 0.7% died.

“Collectively, these data underscore [cemiplimab]’s utility across a variety of patient types, both as a single agent and in combination with chemotherapy,” Ana Baramidze, MD, PhD, head of the Clinical Research Department at Todua Clinic, said in a statement.¹

References

1. 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. Regeneron. September 9, 2025. Accessed September 10, 2025. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years

2. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3. Nat Med. 2022;28(11):2374-2380. doi:10.1038/s41591-022-01977-y