Table 3

Efficacy results of non-ocular melanoma patients (n=89)

Response statusAs % of ITT population (N=96)As % of efficacy population (N=89) who were evaluable for efficacy
Overall (N=89)Prior systemic therapy (n=16)*Prior radiation therapy (n=14)
PFS, median months (95% CI)12.4 (6.4 to 24.9)
ORR, n (%)45 (47)45 (51)10 (63)9 (64)
 CR18 (19)18 (20)5 (31)5 (36)
 PR27 (28)27 (30)5 (31)4 (29)
 SD17 (18)17 (19)2 (13)3 (21)
DCR62 (65)62 (70)12 (75)12 (86)
PD27 (28)27 (30)4 (25)2 (14)
PD-L1 status known (n/N, %)56/89 (63)
 Positive30/56 (54)
 Negative26/56 (46)
ORR (CR+PR; n/N, %)
 PD-L1 positive21/30 (70)
 PD-L1 negative12/26 (46)
DCR (CR+PR+SD; n/N, %)
 PD-L1 positive26/30 (87)
 PD-L1 negative16/26 (62)
  • *Includes BRAF inhibitors and IL-1.

  • BRAF, 8-rat proto-oncogene, serine/threonine kinase; CR, complete response; DCR, disease control rate; IL-1, interleukin-1; ITT, intention-to-treat; ORR, overall response rate; PD, progressive disease; PD-L1, Programmed Death-Ligand 1 ; PFS, progression-free survival; PR, partial response; SD, stable disease.