Data Results from the Phase IA Study of PCI-32765
The study enrolled 56 relapsed or refractory patients with a variety of B cell malignancies to this multi-cohort dose-escalation trial. Forty-eight of these patients are evaluable for response. The response by disease is captured below in the table.
The Phase IA study enrolled patients with multiple disease histologies including CLL/SLL, follicular lymphoma, mantle cell lymphoma, DLBCL, Marginal/Malt and Waldenstrom. The progression-free survival varies by histology. We have described the time on study results by histology. Please refer to our website at http://ir.pharmacyclics.com/events.cfm to review the slides presented by Dr. Nathan Fowler at the 2010 Annual Meeting of the American Society of Hematology.
N | CR | PR | SD | PD | NE* | TETE* | ORR % of ITT** | ORR % of Eval** | ASCO 2010 ORR% of Eval** | ||
Chronic/Small Lymphocytic Leukemia (CLL/SLL) | 16 | 1 | 8** | 2 | 0 | 2 | 1 | 56%** (9/16) | 69%** (9/13) | 82%** (9/11) | |
Follicular Lymphoma (FL) | 16 | 1 | 3 | 5 | 4 | 3 | 25% (4/16) | 31% (4/13) | 27% (3/11) | ||
Mantle Cell Lymphoma (MCL) | 9 | 3 | 4 | 1 | 1 | 78% (7/9) | 78% (7/9) | 75% (3/4) | |||
Diffuse Large B Cell Lymphoma (DLBCL) | 7 | 2 | 1 | 4 | 29% (2/7) | 29% (2/7) | 17% (1/6) | ||||
Marginal / Malt | 4 | 1 | 1 | 1 | 1 | 25% (1/4) | 33% (1/3) | 33% (1/3) | |||
Waldenstrom | 4 | 2 | 1 | 0 | 1 | 50% (2/4) | 67% (2/3) | N/A | |||
Total | 56 | 5 | 20** | 11 | 10 | 6 | 2 | 45% (25/56)** | 52% (25/48)** | 49% (17/35)** | |
* Too Early Too Evaluate (TETE), are patients who are currently on study and have not had their tumor assessment. Not evaluable (NE) are patients who have not completed two cycles of treatment and/or had a least one tumor assessment done. Other abbreviations: Complete response (CR); Partial response (PR); Stable disease (SD); Progressive disease (PD)
**2 additional evaluable patients had a nodal response with lymphocytosis and are excluded in the response categories listed in this ASH table above but were included in the totals from ASCO 2010 (far right column)
With longer-term follow-up of this Phase I trial, PCI-32765 continues to be well tolerated. As reported previously, only two patients of the enrolled 56 patients have experienced a dose limiting toxicity (DLT) on this trial (drug hypersensitivity and delay in dosing due to neutropenia for 7 days). The overall rate of grade >3 adverse events continues to be low, and significant hematologic toxicities have be
