Table 4.
NE | NR | PR | CR | Overall response (PR + CR), n (%) | |
---|---|---|---|---|---|
Part A (n = 12) | 1* | 4† | 3‡ | 4 | 7 (58) |
Part B (n = 4)† | 2 | 1 | 1 | 2 (50) | |
Part A + B ORR | 9 (75) | ||||
95% CI, % | 42.8-94.5 |
NE, not evaluable; NR, no response.
NE due to patient decision to withdraw from study after 4 cycles because of gastrointestinal toxicity.
Four patients from part A who had NR entered part B combination idasanutlin + IFN-α.
Residual splenomegaly likely resulting from known portal vein thrombosis in 1 patient, likely a CR (n = 1).