Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
CompletedPhase 2Results postedLast updated 17 July 2024
What this trial tests
Phase 2 trial testing Copanlisib (Aliqopa, BAY80-6946) in Lymphoma, Non-Hodgkin in 227 participants. Completed in 18 May 2023.
18 and older, any sex, with Lymphoma, Non-Hodgkin. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) Based on Independent Review-Part APrimary· Baseline up to the last patient has completed the 16 weeks of treatment
Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.
Group
Value
95% CI
Part A: Indolent NHL/CLL
43.75
28.73 – 59.68
Part A: Aggressive NHL
27.08
16.83 – 39.57
ORR Based on Independent Review-Part BPrimary· Baseline up to the last patient has completed the 16 weeks of treatment
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
Group
Value
95% CI
Part B: Indolent NHL
59.15
50.60 – 67.32
ORR Based on Investigator Assessment-Part APrimary· Baseline up to the last patient has completed the 16 weeks of treatment
Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.
Group
Value
95% CI
Part A: Indolent NHL/CLL
46.88
31.54 – 62.66
Part A: Aggressive NHL
31.25
20.35 – 43.97
ORR Based on Investigator Assessment-Part BPrimary· Baseline up to the last patient has completed the 16 weeks of treatment
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
Group
Value
95% CI
Part B: Indolent NHL
51.41
42.88 – 59.87
Duration of Response (DOR) Based on Independent Review-Part ASecondary· Baseline up to approximately 6 years
DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \[PD\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of
Group
Value
95% CI
Part A: Indolent NHL/CLL
322
61 – NA
Part A: Aggressive NHL
NA
61 – NA
DOR Based on Independent Review-Part BSecondary· Baseline up to approximately 9 years 7 months
DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \[PD\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of
Group
Value
95% CI
Part B: Indolent NHL
14.9
9.2 – 22.6
DOR Based on Investigator Assessment-Part ASecondary· Baseline up to approximately 6 years
DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \[PD\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of
Group
Value
95% CI
Part A: Indolent NHL/CLL
189
56 – 574
Part A: Aggressive NHL
190
112 – NA
DOR Based on Investigator Assessment-Part BSecondary· Baseline up to approximately 9 years 7 months
DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \[PD\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of
Group
Value
95% CI
Part B: Indolent NHL
11.5
9.2 – 16.1
Progression Free Survival (PFS) Based on Independent Review-Part ASecondary· Baseline up to approximately 6 years
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Group
Value
95% CI
Part A: Indolent NHL/CLL
223
147 – 546
Part A: Aggressive NHL
70
47 – 115
PFS Based on Independent Review-Part BSecondary· Baseline up to approximately 9 years 7 months
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Group
Value
95% CI
Part B: Indolent NHL
11.3
8.1 – 17.6
PFS Based on Investigator Assessment-Part ASecondary· Baseline up to approximately 6 years
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Group
Value
95% CI
Part A: Indolent NHL/CLL
224
172 – 419
Part A: Aggressive NHL
70
47 – 115
PFS Based on Investigator Assessment-Part BSecondary· Baseline up to approximately 9 years 7 months
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Group
Value
95% CI
Part B: Indolent NHL
10.8
7.2 – 12.8
Adverse events — posted to ClinicalTrials.gov
Time frame: After the first study intervention up to 35 days after the end of study intervention, Part A: approximately 6 years. Part B: approximately 9 years 7 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, Part A: approximately 6 years. Part B: approximately 9 years 7 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.
In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.
After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).
Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.
The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03655301 — Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
· Phase 1
· completed
NCT03498430 — Copanlisib Chinese PK Study
· Phase 1
· completed
NCT02367040 — Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
· Phase 3
· completed
NCT02391116 — Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
· Phase 2
· completed
NCT00962611 — BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 17 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01660451.