Therapy Detail

Therapy Name Copanlisib
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Copanlisib Aliqopa BAY80-6946 PIK3CA inhibitor 14 PIK3CD inhibitor 24 Aliqopa (copanlisib) is a selective PIK3CA and PIK3CD inhibitor that prevents activation of Akt, resulting in inhibition of cell cycle progression and increased apoptosis (PMID: 24013662, PMID: 25528022). Aliqopa (copanlisib) is FDA approved for adult patients with follicular lymphoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Advanced Solid Tumor not applicable Copanlisib Phase I Actionable In a Phase I trial, Aliqopa (copanlisib) treatment resulted in no complete or partial response (0/10) and a disese control rate of 40% in patients with advanced solid tumors (PMID: 27915408). 27915408
Unknown unknown Advanced Solid Tumor not applicable Copanlisib Phase I Actionable In a Phase I clinical trial, treatment with Aliqopa (copanlisib) was well-tolerated and demonstrated preliminary activity in patients with advanced solid tumors, with complete response in 2% (1/48), partial response in 4% (2/48), and stable disease in 31% (15/48) of patients (PMID: 27672108). 27672108
ERBB2 positive Her2-receptor positive breast cancer sensitive Copanlisib Preclinical Actionable In a preclinical study, breast cancer cell lines with a PIK3CA activating mutation and/or ERBB2 (HER2)-over expression demonstrated increased sensitivity to inhibition of proliferation by Aliqopa (copanlisib) in culture, compared to ERBB2 (HER2)-negative and wild-type PIK3CA cell lines (PMID: 24170767). 24170767
KRAS amp MET del exon14 non-small cell lung carcinoma predicted - sensitive Copanlisib Preclinical - Patient cell culture Actionable In a preclinical study, non-small cell carcinoma patient-derived cells with KRAS amplification and a MET exon 14 splice site mutation demonstrated some apoptotic activity and inhibition of proliferation in culture when treated with Aliqopa (copanlisib) (PMID: 30072474). 30072474
Unknown unknown diffuse large B-cell lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in complete response in 6% (1/17), partial response in 6% (1/17) and stable disease in 41% (7/17) of patients with diffuse large B-cell lymphoma (PMID: 24852792). 24852792
Unknown unknown chronic lymphocytic leukemia not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in partial response in 67% (6/9) and stable disease in 22% (2/9) of patients with chronic lymphocytic leukemia (PMID: 24852792). 24852792
Unknown unknown follicular lymphoma not applicable Copanlisib FDA approved Actionable In a Phase II trial that supported FDA approval, Aliqopa (copanlisib) treatment in patients with follicular lymphoma resulted in an objective tumor response rate of 58.7% (61/104) including 14.4% (15/61) patients experiencing a complete response and 44.2% (46/61) patients experiencing a partial response, stable disease in 33.7% (35/104) of patients, and a duration of response of 370 days (Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 7535-7535; NCT01660451). detail...
Unknown unknown follicular lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in complete response in 20% (2/10), partial response in 20% (2/10) and stable disease in 60% (6/10) of patients with follicular lymphoma (PMID: 24852792). 24852792
Unknown unknown peripheral T-cell lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in partial response in 50% (2/4) of patients with peripheral T-cell lymphoma (PMID: 24852792). 24852792
Unknown unknown mantle cell lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in complete response in 17% (1/6) and partial response in 67% (4/6) of patients with mantle cell lymphoma (PMID: 24852792). 24852792
Unknown unknown lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, Aliqopa (copanlisib) treatment resulted in partial response in 20% (1/5) and stable disease in 40% (2/5) of patients with transformed lymphoma (PMID: 24852792). 24852792
Unknown unknown lymphoma not applicable Copanlisib Phase II Actionable In a Phase II trial, treatment with Aliqopa (copanlisib) in patients with indolent lymphoma resulted in an objective response rate of 59% (84/142), including a complete response in 12%, and demonstrated a median duration of response of 22.6 months and a median progression-free survival of 11.2 months (PMID: 28976790; NCT01660451). 28633365 28976790
Clinical Trial Phase Therapies Title Recruitment Status
NCT02253420 Phase I Copanlisib Itraconazole COPANLISIB (BAY80-6946) Drug-drug Interaction Study in Advanced Solid Tumor Patients Active, not recruiting
NCT02626455 Phase III Vincristine Prednisone Aldoxorubicin +Cyclophosphamide + Prednisone + Rituximab + Vincristine Copanlisib Bendamustine + Rituximab Rituximab Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) Recruiting
NCT02728258 Phase II Copanlisib Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer Suspended
NCT02155582 Phase I Copanlisib Copanlisib Pharmacodynamic Study Completed
NCT02391116 Phase II Copanlisib Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Completed
NCT02369016 Phase III Copanlisib Phase III Copanlisib in Rituximab-refractory iNHL Active, not recruiting
NCT03458728 Phase Ib/II Copanlisib Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients Recruiting
NCT02455297 Phase II Copanlisib Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL) Terminated
NCT02367040 Phase III Rituximab Copanlisib Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) Recruiting
NCT01660451 Phase II Copanlisib Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas Active, not recruiting