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PCI-32765 · 6 trials · 5 indications
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (\>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by \>=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | PLACEBO_COMPARATOR | Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo. |
| Treatment Arm B | EXPERIMENTAL | Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib). |
| PCI-32765 (Ibrutinib) | EXPERIMENTAL | - |
| PCI-32765 | EXPERIMENTAL | During Period 1, all patients will receive PCI-32765 560 mg administered by mouth (Treatment A). In Periods 2 and 3, patients will receive PCI-32765 560 mg administered by mouth without grapefruit juice (Treatment B) and PCI-32765 140 mg administered by mouth with grapefruit juice (Treatment C) according to a randomization schedule. An intravenous dose of 13C6 PCI-32765 will be administered 2 hours after each oral dose for reference purposes. |
| PCI-32765 + Rifampin | EXPERIMENTAL | Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13. |
| Patients with mild hepatic function | EXPERIMENTAL | Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1. |
| Patients with moderate hepatic function | EXPERIMENTAL | Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1. |
| Patients with severe hepatic function | EXPERIMENTAL | Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1. |
| Patients with normal hepatic function | EXPERIMENTAL | Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1. |
| Name | Type | Description |
|---|---|---|
| Bendamustine | DRUG | 90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6. |
| Rituximab | DRUG | 375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Cyclophosphamide | DRUG | 750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Doxorubicin | DRUG | 50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Vincristine | DRUG | 1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6. |
| Prednisone | DRUG | 100 mg administered orally on Days 1 to 5 of Cycles 1 to 6. |
| PCI-32765 (Ibrutinib) | DRUG | 560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1. |
| Placebo | DRUG | Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1. |
| PCI-32765 (Treatment A) | DRUG | 560 mg capsules administered by mouth on Day 1, Period 1 |
| PCI-32765 (Treatment B) | DRUG | 560 mg capsules administered by mouth (without grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule |
| PCI-32765 (Treatment C) | DRUG | 140 mg capsule administered by mouth (with grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule |
| 13C6 PCI-32765 (reference) | DRUG | 100 mcg administered intravenously 2 h after study drug |
| PCI-32765 | DRUG | PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 |
| Rifampin | DRUG | Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765. |
Inclusion Criteria: * Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation *...
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PCI-32765 is an investigational small molecule being studied in healthy volunteers, in participants with hepatic impairment, and in patients with lymphoma, including recurrent mature B-cell neoplasms and refractory follicular lymphoma. It has also been evaluated in combination with other agents in previously treated indolent non-Hodgkin lymphoma.
PCI-32765 is a small molecule that targets Bruton's tyrosine kinase (BTK). It is being developed by Johnson & Johnson (JNJ) for the treatment of B-cell malignancies, including lymphoma.
PCI-32765 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The drug is also known as ibrutinib.
PCI-32765 has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. All trials listed are completed, with no active trials ongoing. The drug remains investigational and is not approved for any indication.
PCI-32765 has been studied in four completed trials: NCT01767948 (hepatic impairment, Phase 1), NCT01779791 (refractory follicular lymphoma, Phase 2), NCT01866033 (healthy volunteers, bioavailability, Phase 1), and NCT01974440 (combination therapy in indolent non-Hodgkin lymphoma, Phase 3).
Yes, PCI-32765 is also known as ibrutinib. Clinical trial NCT01779791 explicitly refers to PCI-32765 (Ibrutinib) in its title, confirming that the two names refer to the same drug.