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|BAY806946 | PIK3CA inhibitor 24 PIK3CD inhibitor 27 | 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 H1047R | bone ameloblastoma | 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 and progression-free survival of 24.6 months and an overall survival of 25.8 months in a patient with ameloblastoma of the mandible harboring PIK3CA H1047R (PMID: 35133871; NCT02465060). | 35133871 |
| PIK3CA E542K | endometrial serous 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 and progression-free survival of 5.4 months and an overall survival of 8.2 months in a patient with endometrial serous adenocarcinoma harboring PIK3CA E542K (PMID: 35133871; NCT02465060). | 35133871 |
| 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 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 |
| 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 |
| 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 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 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 |
| 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 |
| 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 E545K | 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 and progression-free survival of 7.3 months and an overall survival of 19.8 months in a patient with clear cell carcinoma of anterior abdominal wall harboring PIK3CA E545K (PMID: 35133871; NCT02465060). | 35133871 |
| PIK3CA act mut | 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 16% (4/25, all partial response), a clinical benefit rate of 36% (9/25), a median progression-free survival of 3.4 months, and a median overall survival of 5.9 months in patients with advanced solid tumors harboring activating PIK3CA mutations (PMID: 35133871; NCT02465060). | 35133871 |
| KIT V560_Y578del KIT T670I | gastrointestinal stromal tumor | sensitive | Copanlisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Aliqopa (copanlisib) inhibited cell growth and PI3K signaling in a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del and KIT T670I in culture, and inhibited tumor growth in cell line xenograft models (PMID: 32371592). | 32371592 |
| PIK3CA R88L PIK3CA E453del PIK3CA T1052K PTEN loss PTEN mut | endometrial carcinoma | sensitive | Copanlisib | Phase I | Actionable | In a Phase I clinical trial, an endometrial carcinoma patient harboring PIK3CA T1052K, R88L, and E453del, as well as a PTEN mutation and loss of PTEN protein expression demonstrated a complete response to treatment with Aliqopa (copanlisib) (PMID: 27672108). | 27672108 |
| KIT V560_Y578del | gastrointestinal stromal tumor | sensitive | Copanlisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Aliqopa (copanlisib) inhibited cell growth and PI3K signaling in a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del in culture, and inhibited tumor growth in cell line xenograft models (PMID: 32371592). | 32371592 |
| PIK3CA act mut | breast cancer | sensitive | Copanlisib | Case Reports/Case Series | 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 H1047R | myxoid 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 and progression-free survival of 23.7 months and an overall survival of 25.8 months in a patient with myxoid liposarcoma harboring PIK3CA H1047R (PMID: 35133871; NCT02465060). | 35133871 |
| KIT exon11 KIT V654A | gastrointestinal stromal tumor | sensitive | Copanlisib | Preclinical - Cell culture | Actionable | In a preclinical study, Aliqopa (copanlisib) inhibited cell growth and PI3K signaling in a gastrointestinal stromal tumor cell line harboring a KIT exon 11 deletion and KIT V654A in culture (PMID: 32371592). | 32371592 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02253420 | Phase I | Copanlisib Itraconazole | COPANLISIB (BAY80-6946) Drug-drug Interaction Study in Advanced Solid Tumor Patients | Completed | USA | CAN | 0 |
| NCT02391116 | Phase II | Copanlisib | Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) | Completed | ITA | GBR | FRA | DNK | DEU | CAN | BEL | AUS | 2 |
| NCT02155582 | Phase I | Copanlisib | Copanlisib Pharmacodynamic Study | Completed | GBR | FRA | BEL | 0 |
| NCT02455297 | Phase II | Copanlisib | Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL) | Terminated | USA | 0 |
| NCT02728258 | Phase II | Copanlisib | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Completed | USA | 0 |
| NCT04803123 | Phase I | Copanlisib | Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL | Terminated | USA | 0 |
| NCT02626455 | Phase III | Vincristine Sulfate Prednisone Aldoxorubicin + Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Copanlisib Bendamustine + Rituximab Rituximab | Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4) | Terminated | USA | TUR | SVK | ROU | POL | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BGR | BEL | AUS | 13 |
| NCT04433182 | Phase II | Bendamustine + Copanlisib + Rituximab Copanlisib | Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma | Active, not recruiting | ITA | 0 |
| NCT03458728 | Phase Ib/II | Copanlisib | Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients | Terminated | USA | 0 |
| NCT02369016 | Phase III | Copanlisib | Phase III Copanlisib in Rituximab-refractory iNHL | Completed | TUR | POL | ITA | GRC | BRA | BGR | 4 |
| 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 | Completed | USA | TUR | SWE | POL | NZL | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CAN | BGR | BEL | AUT | AUS | 5 |
| NCT04750941 | Phase II | Copanlisib | Study of Copanlisib and Ketogenic Diet | Active, not recruiting | USA | 0 |
| NCT02367040 | Phase III | Rituximab Copanlisib | Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) | Active, not recruiting | USA | TUR | SVK | ROU | POL | NZL | LTU | ITA | IRL | HUN | GRC | FRA | ESP | DEU | BRA | BGR | BEL | AUT | AUS | ARG | 17 |
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