Table 2

Summary of tumor response and survival data

Study 001 (n=43)Study 012 (n=16)Full analysis set (N=59)
Confirmed BOR, n (%)
 CR3 (7.0)2 (12.5)5 (8.5)
 PR9 (20.9)4 (25.0)13 (22.0)
 SD6 (14.0)2 (12.5)8 (13.6)
 PD20 (46.5)7 (43.8)27 (45.8)
 Not evaluable5 (11.6)1 (6.3)6 (10.2)
 Delayed PR*3 (7.0)03 (5.1)
Confirmed ORR, n (%; 95% CI)12 (27.9; 15.3 to 43.7)6 (37.5; 15.2 to 64.6)18 (30.5; 19.2 to 43.9)
Disease control, n (%; 95% CI)†18 (41.9; 27.0 to 57.9)8 (50.0; 24.7 to 75.3)26 (44.1; 31.2 to 57.6)
Total clinical response rate, n (%; 95% CI)‡15 (34.9; 21.0 to 50.9)6 (37.5; 15.2 to 64.6)§21 (35.6; 23.6 to 49.1)§
Duration of response, median, months (95% CI)19.1 (4.2 to 27.4)NR (4.2 to NR)19.1 (9.6 to 27.4)
KM-estimated PFS, median, months (95% CI)2.8 (1.4 to 4.6)3.3 (1.4 to NR)2.8 (1.4 to 5.5)
KM-estimated PFS rate, % (95% CI)
 6 months31.0 (17.8 to 45.0)43.8 (19.8 to 65.6)34.2 (22.4 to 46.4)
 12 months26.2 (14.1 to 40.0)29.2 (9.6 to 52.3)27.0 (16.3 to 38.9)
 18 months23.3 (11.8 to 37.0)24.3 (13.8 to 36.4)
KM-estimated OS, median, months (95% CI)16.2 (7.1 to NR)NR (3.7 to NR)NR (8.6 to NR)
KM-estimated OS rate, % (95% CI)
 6 months73.7 (57.5 to 84.5)72.1 (41.5 to 88.6)73.1 (59.4 to 82.9)
 12 months56.5 (40.1 to 70.0)72.1 (41.5 to 88.6)58.8 (44.3 to 70.8)
 18 months48.8 (32.8 to 63.0)51.4 (36.5 to 64.3)
  • Data are according to investigator-assessed RECIST V.1.1.

  • *Due to confirmed PD before onset of response, these patients did not meet response criteria by RECIST V.1.1.

  • †CR plus PR plus SD.

  • ‡ORR per RECIST V.1.1 plus delayed PR after initial disease progression.

  • §One additional patient with a vulvar tumor had an unconfirmed CR.

  • BOR, best overall response; CR, complete response; HPV, human papillomavirus; KM, Kaplan-Meier; NR, not reached; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.