Cemiplimab monotherapy can improve long-term survival outcomes, when compared with chemotherapy, in patients with newly diagnosed, advanced non-small cell lung cancer (NSCLC), according to research presented at ESMO Congress 2022.
Updated results from the EMPOWER-Lung 1 study showed that cemiplimab can improve progression-free survival (PFS) and overall survival (OS) at 3 years.
These results support the use of cemiplimab as a first-line, chemotherapy-free treatment option for advanced NSCLC, said study presenter Mustafa Özgüroğlu, MD, of İstanbul University-Cerrahpaşa in Turkey.
In this phase 3 study (ClinicalTrials.gov Identifier: NCT03088540), Dr Özgüroğlu and colleagues analyzed 712 patients with treatment-naïve, advanced NSCLC. The patients were randomly assigned to receive cemiplimab (n=357) or investigator’s choice of chemotherapy (n=355). Baseline characteristics were well balanced between the treatment arms.
Cemiplimab was given at 350 mg every 3 weeks for 108 weeks or until disease progression. Chemotherapy was given for 4 to 6 cycles.
If their disease progressed, patients in the chemotherapy arm could cross over to receive cemiplimab, and patients in the cemiplimab arm could receive cemiplimab plus chemotherapy. Ultimately, 75% of patients in the chemotherapy arm crossed over to receive cemiplimab, and 18% of patients in the cemiplimab arm went on to receive cemiplimab plus chemotherapy.
At the data cutoff of March 4, 2022, the median OS was 23.4 months in the cemiplimab arm and 13.7 months in the chemotherapy arm (hazard ratio [HR], 0.63; 95% CI, 0.52-0.77; P =.0001). The median PFS was 6.3 months and 5.3 months, respectively (HR, 0.56; 95% CI, 0.47-0.67; P =.0001).
The overall response rate (ORR) was 42.3% in the cemiplimab arm and 21.4% in the chemotherapy arm (odds ratio [OR], 2.691; 95% CI, 1.936-3.740; P <.0001). The complete response (CR) rates were 8.1% and 2.0%, respectively.
In the subset of patients with PD-L1 expression of 50% or greater (cemiplimab, n=284; chemotherapy, n=281), cemiplimab was associated with improved outcomes. The ORR was 46.5% in the cemiplimab arm and 21.0% in the chemotherapy arm (OR, 3.264; 95% CI, 2.255-4.724; P <.0001). The CR rates were 8.1% and 2.1%, respectively.
In this PD-L1-high subgroup, the median OS was 26.1 months in the cemiplimab arm and 13.3 months in the chemotherapy arm (HR, 0.57; 95% CI, 0.46-0.71; P =.0001). The median PFS was 8.1 months and 5.3 months, respectively (HR, 0.51; 95% CI, 0.42-0.62; P =.0001).
The researchers also looked at outcomes in the 64 patients from the cemiplimab arm who received cemiplimab plus chemotherapy after progression. These patients achieved an ORR of 31.3%, and 3 patients achieved a CR. The median OS was 27.4 months for the pre- and post-progression periods together and 15.1 months for the post-progression period only.
The safety results in this updated analysis were consistent with the previous analysis, according to Dr Özgüroğlu.
Disclosures: This research was supported by Regeneron Pharmaceuticals, Inc., and Sanofi. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for a full list of disclosures.
Özgüroğlu M, Kilickap S, Sezer A, et al. Three years survival outcome and continued cemiplimab (CEMI) beyond progression with the addition of chemotherapy (chemo) for patients (pts) with advanced non-small cell lung cancer (NSCLC): The EMPOWER-Lung 1 trial. Presented at ESMO 2022; September 9-13, 2022. Abstract LBA54.