Phase 3
N=458
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
Lymphoma,Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT02367040 ↗Enrolled (actual)
458
Serious AEs
42.6%
Results posted
Jan 2022
Primary outcome: Primary: Progression Free Survival (PFS) Based on Independent Central Review. — 21.5; 13.8; 23.2; 13.8 Months — p=0.000002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Copanlisib (Aliqopa, BAY80-6946) (Drug); Placebo (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Based on Independent Central Review. |
21.5; 13.8; 23.2; 13.8; 22.4; 14.0 | 0.000002 sig |
| SECONDARY Objective Response Rate (ORR) |
80.8; 47.7; 80.5; 49.7 | <0.000001 sig |
| SECONDARY Complete Response Rate (CRR) |
33.9; 14.6; 34.2; 15.2 | <0.000001 sig |
| SECONDARY Duration of Response (DOR) |
20.4; 17.3; 25.9; 15.2 | 0.030371 sig |
| SECONDARY Disease Control Rate (DCR) |
89.3; 84.8; 89.3; 84.8 | 0.097339 |
| SECONDARY Time to Progression (TTP) |
22.3; 13.8; 27.7; 13.8 | <.000001 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.436458 |
| SECONDARY Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. |
5.5; 5.5; 5.5; 5.5 | 0.692610 |
| SECONDARY Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. |
NA; NA; 38.5; 35.7 | 0.510038 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date. |
307; 134; 293; 95; 218; 92 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date. |
307; 137; 295; 98; 218; 93 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis |
307; 137; 295; 98; 218; 93 | — |
Summary
The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients, with histological subtype limited to:
- Follicular lymphoma(FL) grade1-2-3a
- Small lymphocytic lymphoma(SLL) with absolute lymphocyte count 8.5% at Screening
- Known history of human immunodeficiency virus (HIV) infection
- Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
- Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors.
- Prior treatment with copanlisib
- Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.
Data sourced from ClinicalTrials.gov (NCT02367040). 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.