Randomized phase II study of pembrolizumab (P) alone versus pegilodecakin (PEG) in combination with P as first-line (1L) therapy in patients (pts) with stage IV non-small cell lung cancer (NSCLC) with high PD-L1 expression (CYPRESS 1).
Abstract No : 9563
Abstract Type : Poster Session
Indication : PD-L1 selected NSCLC
Intervention : Pembrolizumab (P) alone versus pegilodecakin (PEG) in combination with P
Company : Eli Lilly and Company
Technology : Monoclonal antibody
As of Dec 6, 2019, 101 pts were randomized to PEG+P (n=51) or P (n=50). Median follow-up time was 10.0 months (95% CI [8.4, 11.1]). Results for PEG+P versus P were: ORR per investigator was 47% v. 44% (p=0.76), ORR per BICR was 53% v. 46%(p=0.78), mPFS per investigator was 6.3 v. 6.1 months with HR = 0.94 (95% CI [0.54, 1.63];p=0.82), mPFS per BICR was 6.4 v. 7.2 months with HR = 1.10 (95%CI [0.62, 1.96]; p=0.74), and mOS was 16.3 months v. not reached with HR = 1.36 (95% CI [0.66, 2.77]; pvalue=0.40). Gr $3 treatment related adverse events (TRAEs) were 62% for PEG+P versus 19% for P. Gr $3 TRAEs with $10% incidence included anemia (20% vs. 0%) and thrombocytopenia (12% vs.2%). Biomarker data on immunostimulatory signals of the IL-10R pathway will be included.
Adding PEG to P did not lead to improvement in ORR, PFS, or OS, in 1L advanced NSCLC with high PD-L1 expression. PEG+P arm demonstrated expected safety profile but overall higher toxicity compared to pembrolizumab alone.
Adding pegilodecakin to pembrolizumab did not lead to improvement in ORR, PFS, or OS, in 1L advanced NSCLC with high PD-L1 expression