Clinical Data Key highlights of KEYNOTE-695 include:

• Of the first 54 out of 100 planned patients evaluated by investigator-assessed RECIST v1.1:
• ORR was 30% (95%CI [18.0%, 43.6%]) (16/54)
• Complete response rate was 6% (3/54)
• All responses were confirmed by scans taken no earlier than after 6 months on study
• 9% (5/54) patients had 100% reduction of target lesions
• ORR was 35% (n=6/17) in patients with Stage IV M1c/M1d disease
• ORR was 40% (n=6/15) in patients with prior exposure to ipilimumab
• Median duration of response (mDOR) is currently 12.2 months (95% CI, 5.6-NE)
• Median study follow-up was 13.5 months
• Excellent safety profile resulting from intramural treatment approach
• Only 5.4% Grade 3 treatment-related AEs
• No grade 4/5 treatment-related AEs
• This study enrolled rapidly progressing patients with a short interval of 1.2 months (median) between the last dose of anti-PD-1 and study treatment