Phase 2
N=67
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse, Large B-Cell, Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02391116 ↗Enrolled (actual)
67
Serious AEs
65.7%
Results posted
Jan 2018
Primary outcome: Primary: Objective Response Rate (ORR) in Total Population Based on Investigator Assessment — 19.4; 25.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Copanlisib (Aliqopa, BAY80-6946) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) in Total Population Based on Investigator Assessment |
19.4; 25.0 | — |
| PRIMARY ORR by CD79b Status Based on Investigator Assessment |
22.2; 20.0; 15.4; 25.0; 25.0 | — |
| PRIMARY ORR by DLBCL/COO Subtype Based on Investigator Assessment |
31.6; 13.3; 33.3; 13.3; 37.5; 13.6 | — |
| SECONDARY Duration of Response (DOR) in Total Population |
132 | — |
| SECONDARY DOR by CD79b Status |
516; 113; 113 | — |
| SECONDARY DOR by DLBCL/COO Subtype |
193; 183; 52; 113 | — |
| SECONDARY Progression-free Survival (PFS) in Total Population |
54 | — |
| SECONDARY PFS by CD79b Status |
73; 52; 56 | — |
| SECONDARY PFS by DLBCL/COO Subtype |
73; 52; 84; 51 | — |
| SECONDARY Overall Survival (OS) in Total Population |
224 | — |
| SECONDARY OS by CD79b Status |
178; 242; 224 | — |
| SECONDARY OS by DLBCL/COO Subtype |
210; 287; 164; 160 | — |
| SECONDARY Duration of Stable Disease (DOSD) in Total Population |
106 | — |
| SECONDARY Disease Control Rate (DCR) in Total Population |
40.3 | — |
| SECONDARY DCR by CD79b Status |
55.6; 40.0; 30.8 | — |
| SECONDARY DCR by DLBCL/COO Subtype |
52.6; 40.0; 33.3; 26.7 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
65; 44 | — |
Summary
To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
- Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
- Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
- Patients must have measurable disease.
- Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy (HDC) and stem cell transplant (SCT).
- A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
- Adequate bone marrow, liver and renal function.
Exclusion Criteria
- Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
- Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
- Current central nervous system (CNS) involvement by lymphoma.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
- Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
- New York Heart Association (NYHA) class III or IV heart disease.
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
- Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.
Data sourced from ClinicalTrials.gov (NCT02391116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.