Therapy Detail
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| Therapy Name | Copanlisib |
| Synonyms | |
| Therapy Description |
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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Copanlisib | Aliqopa | BAY80-6946 | PIK3CA inhibitor 16 PIK3CD inhibitor 25 | 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E542K | endometrial adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in stable disease in 2 patients with serous endometrial adenocarcinoma harboring PIK3CA E542K (PMID: 31934607). | 31934607 |
| 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, PMID: 28633365; NCT01660451). | 28633365 28976790 |
| 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 |
| PIK3CA mutant | Advanced Solid Tumor | predicted - sensitive | Copanlisib | Phase II | Actionable | In a Phase II trial (NCI MATCH EAY131-Z1F), Aliqopa (copanlisib) treatment resulted in an objective response rate of 11% (3/28, 3 partial response) and a clinical benefit rate of 32% (9/28) in patients with advanced solid tumors harboring PIK3CA mutations (J Clin Oncol 38: 2020 (suppl; abstr 3506); NCT02465060). | detail... |
| PIK3CA mutant | endometrial carcinoma | no benefit | Copanlisib | Phase II | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in stable disease as best response in 54.5% (6/11) of patients with endometrial carcinoma harboring PIK3CA mutations, with a median progression-free survival of 2.8 months and a median overall survival of 15.2 months (PMID: 31934607). | 31934607 |
| ETV6 - RUNX1 | acute lymphoblastic leukemia | not applicable | Copanlisib | Preclinical - Cell culture | Emerging | In a preclinical study, knockout of ETV6-RUNX1 in acute lymphocytic leukemia cells combined with Aliqopa (copanlisib) resulted in greater decreased cell viability and phosphorylation of Akt and Mtor compared to knockdown alone in culture (PMID: 31952221). | 31952221 |
| PIK3CA act mut | breast cancer | sensitive | Copanlisib | Phase I | Actionable | In a Phase I clinical trial, treatment with Aliqopa (copanlisib) resulted in partial response in one and stable disease in another patient with breast cancer harboring activating PIK3CA mutations (PMID: 27672108; NCT00962611). | 27672108 |
| PIK3CA act mut | 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 |
| PIK3CA H1047X | endometrial mixed adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in progressive disease in a patient with endometrial mixed adenocarcinoma harboring a PIK3CA H1047 mutation (PMID: 31934607). | 31934607 |
| PIK3CA Q546X | endometrial adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in 1 stable disease and 1 progressive disease in 2 patients with endometrioid adenocarcinoma harboring PIK3CA Q546 mutations, and stable disease in a patient with serous endometrial adenocarcinoma harboring a PIK3CA Q546 mutation (PMID: 31934607). | 31934607 |
| 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 |
| 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 |
| PIK3CA N345K | endometrial mixed adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in stable disease in a patient with endometrial mixed adenocarcinoma harboring PIK3CA N345K (PMID: 31934607). | 31934607 |
| PIK3CA mutant | liposarcoma | predicted - sensitive | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II trial (NCI MATCH EAY131-Z1F), Aliqopa (copanlisib) treatment resulted in a partial response in a patient with liposarcoma harboring PIK3CA mutation (J Clin Oncol 38: 2020 (suppl; abstr 3506); NCT02465060). | detail... |
| 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... 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 | 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 |
| PIK3CA E545X | endometrial adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in progressive disease in a patient with endometrioid adenocarcinoma harboring a PIK3CA E545 mutation, and progressive disease in a patient with serous endometrial adenocarcinoma harboring a PIK3CA E545 mutation (PMID: 31934607). | 31934607 |
| PIK3CA mutant | uterine cancer | predicted - sensitive | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II trial (NCI MATCH EAY131-Z1F), Aliqopa (copanlisib) treatment resulted in a partial response in a patient with uterine cancer harboring PIK3CA mutation (J Clin Oncol 38: 2020 (suppl; abstr 3506); NCT02465060). | detail... |
| 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 |
| PIK3CA H1047X | endometrial adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in progressive disease in a patient with endometrioid adenocarcinoma harboring a PIK3CA H1047 mutation (PMID: 31934607). | 31934607 |
| 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 |
| PIK3CA M1043I | endometrial adenocarcinoma | no benefit | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II (NRG-GY008) trial, Aliqopa (copanlisib) was well tolerated but demonstrated limited efficacy, resulted in stable disease in a patient with endometrioid adenocarcinoma harboring PIK3CA M1043I (PMID: 31934607). | 31934607 |
| PIK3CA mutant | clear cell adenocarcinoma | predicted - sensitive | Copanlisib | Case Reports/Case Series | Actionable | In a Phase II trial (NCI MATCH EAY131-Z1F), Aliqopa (copanlisib) treatment resulted in a partial response in a patient with clear cell carcinoma of anterior abdominal wall harboring PIK3CA mutation (J Clin Oncol 38: 2020 (suppl; abstr 3506); NCT02465060). | detail... |
| ERBB2 amp PIK3CA mut | Her2-receptor positive breast cancer | sensitive | Copanlisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Aliqopa (copanlisib) promoted tumor regression in xenograft models of a human ERBB2 (HER2)-amplified breast cancer cell line harboring a PIK3CA activating mutation (PMID: 24170767). | 24170767 |
| 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 | 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT02253420 | Phase I | Copanlisib Itraconazole | COPANLISIB (BAY80-6946) Drug-drug Interaction Study in Advanced Solid Tumor Patients | Completed |
| NCT02728258 | Phase II | Copanlisib | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Active, not 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 |
| NCT02391116 | Phase II | Copanlisib | Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) | Completed |
| 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) | Active, not recruiting |
| NCT02369016 | Phase III | Copanlisib | Phase III Copanlisib in Rituximab-refractory iNHL | Active, not recruiting |
| NCT02155582 | Phase I | Copanlisib | Copanlisib Pharmacodynamic Study | Completed |
| 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 |
| NCT02465060 | Phase II | Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Recruiting |
| NCT02367040 | Phase III | Rituximab Copanlisib | Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) | Active, not recruiting |
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