Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCI-32765 · 7 trials · 15 indications
The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria
The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a \>/= 50% decrease in the sum of the product of diameters of the target lesions, and \>/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2
Number of participants who had experienced at least one treatment emergent AEs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | PCI-32765 420 mg per day |
| Cohort 2 | EXPERIMENTAL | PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week |
| Cohort 3 | EXPERIMENTAL | PCI-32765 840 mg per day |
| Cohort 4 | EXPERIMENTAL | PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week |
| Participants received PCI-32765 560 mg daily | EXPERIMENTAL | Participants were enrolled and received 560 mg/day dose, stratified into 2 groups based on prior bortezomib exposure. |
| PCI-32765 | EXPERIMENTAL | - |
| PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR) | EXPERIMENTAL | - |
| PCI-32765 plus bendamustine/rituximab (BR) | EXPERIMENTAL | - |
| Group 1 | EXPERIMENTAL | In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing |
| Group 2 | EXPERIMENTAL | In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1) |
| Group 3 | EXPERIMENTAL | In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily |
| Name | Type | Description |
|---|---|---|
| PCI-32765 | DRUG | - |
| Dexamethasone | DRUG | - |
| ofatumumab | DRUG | per package insert as an IV infusion |
Inclusion Criteria: * Diagnosis of symptomatic MM with measurable disease, defined here as having at least one of the following: 1. Serum monoclonal protein (M-protein) ≥0.5 g/dL as determined by serum protein electrophoresis (SPEP) 2. Urine M-protein ≥200 mg/24 hrs 3. Serum free light chain...
PCI-32765 is an investigational small molecule being studied for use in multiple myeloma, B-cell lymphoma, B-cell chronic lymphocytic leukemia, and mantle cell lymphoma. It is being developed by AbbVie Inc. (ABBV) and has completed four clinical trials in these oncology indications.
PCI-32765 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in the oncology therapeutic area, studied for B-cell malignancies including chronic lymphocytic leukemia and mantle cell lymphoma.
PCI-32765 has completed Phase 1 and Phase 2 clinical trials. The completed trials include Phase 1 studies in B-cell lymphoma, chronic lymphocytic leukemia, and combination regimens, as well as a Phase 2 study in mantle cell lymphoma. It remains investigational and is not FDA approved.
PCI-32765 has completed four clinical trials: NCT00849654 in recurrent B-cell lymphoma, NCT01105247 in chronic lymphocytic leukemia, NCT01236391 in relapsed/refractory mantle cell lymphoma, and NCT01292135 combining PCI-32765 with FCR or BR regimens in chronic lymphocytic leukemia. All trials are completed.
PCI-32765 is the investigational name for the drug that is also known as ibrutinib. It is being developed by AbbVie Inc. (ABBV) for B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, and B-cell lymphoma. The drug has completed Phase 1 and Phase 2 trials.