EMPOWER-Lung 1: Phase 3 first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%

Abstract No : Abstract LBA52

Indication : Non-small cell lung cancer

Intervention : PD-1/PD-L1 inhibitor

Company : Regeneron

Technology : PD-1/PD-L1 inhibitor

Results:

The late-breaking ESMO presentation expands on topline results shared in April. In the overall trial population (n=710), the median follow-up was 13 months for both Libtayo (n=356; range: <1-32 months) and chemotherapy (n=354; range: <1-32 months).

Among these patients, Libtayo demonstrated the following results compared to chemotherapy:

32% reduced risk of death (hazard ratio HR=0.68; 95% confidence interval CI: 0.53-0.87; p=0.0022).
22-month median overall survival (OS; 95% CI: 18 months to not yet evaluable) compared to 14 months (95% CI: 12-19 months).
41% reduced risk of disease progression (HR=0.59; 95% CI: 0.49-0.72; p<0.0001). The median progression-free survival (PFS) was 6.2 months (95% CI: 4.5-8.3 months) compared to 5.6 months (95% CI: 4.5-6.1 months).
37% objective response rate (ORR; 95% CI: 32-42%; 3% complete response CR and 33% partial response PR rate) compared to 21% ORR (95% CI: 17-25%; 1% CR and 20% PR rate).

A prespecified analysis of data from patients whose cancers had confirmed PD-L1 expression ≥50% (n=563) was also conducted. In this group, the median follow-up was 11 months for both Libtayo (n=283; range: <1-32 months) and chemotherapy (n=280; range: <1-30 months), and Libtayo demonstrated the following results compared to chemotherapy:

43% reduced risk of death (HR=0.57; 95% CI: 0.42-0.77; p=0.0002).
Median OS was not yet reached (95% CI: 18 months to not yet evaluable) compared to 14 months (95% CI: 11-18 months).
46% reduced risk of disease progression (HR=0.54; 95% CI: 0.43-0.68; p<0.0001). The median PFS was 8 months (95% CI: 6-9 months) compared to 6 months (95% CI: 5-6 months).
39% ORR (95% CI: 34-45%; 2% CR and 37% PR rate) compared to 20% ORR (95% CI: 16-26%; 1% CR and 19% PR rate).

Conclusion:

Results from EMPOWER-Lung 1 trial showed that Libtayo (cemiplimab) as a monotherapy increases overall survival and could reduced the risk of death by 43% compared to chemotherapy in first-line advanced NSCLC patients whose cancer had confirmed PD-L1 expression of 50% or greater. These results support Libtayo as a potential new option for anti-PD-1 monotherapy in first-line advanced NSCLC patients with PD-L1≥50%.