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
Results:
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.
Conclusion:
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.
Commentary:
Adding pegilodecakin to pembrolizumab did not lead to improvement in ORR, PFS, or OS, in 1L advanced NSCLC with high PD-L1 expression
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