Table 5.
PF-06647263 |
PF-06647263 |
|
---|---|---|
Part 1 |
Part 2 |
|
Best overall response, n (%) | Dose escalation N = 481 |
Expansion cohort 0.015 mg/kg QW N= 12 |
CR | 0 | 0 |
PR | 5 (10.4) | 1 (8.3) |
uPR | 0 | 1 (8.3) |
SD ≥126 days | 8 (16.7) | 1 (8.3) |
SD <126 days | 12 (25.0) | 1 (8.3) |
Disease progression | 8 (16.7) | 6 (50.0) |
Symptomatic deterioration | 0 | 1 (8.3) |
Early death | 2 (4.2) | 0 |
Indeterminate | 6 (12.5) | 1 (8.3) |
ORR (CR + PR) | 5 (10.4) | 1 (8.3) [95% exact CI 0.2–38.5] |
CBR rate (CR + PR + uPR + SD ≥ 126 days) | 13 (27.1) | 3 (25.0) [95% exact CI 5.5–57.2] |
Seven (14.6%) patients had no measurable disease at baseline.
Abbreviations: CBR, clinical benefit response rate; CI, confidence interval; CR, complete response; ORR, objective response rate; PR, partial response; QW, weekly; SD, stable disease; uPR, unconfirmed PR.