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 23 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 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
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
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 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 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 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
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 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 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
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 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 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
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 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 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 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 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
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
NCT04750941 Phase II Copanlisib Study of Copanlisib and Ketogenic Diet Active, not recruiting USA 0
NCT02455297 Phase II Copanlisib Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL) Terminated USA 0
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
NCT02367040 Phase III Rituximab Copanlisib Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) Active, not recruiting USA | NZL | ITA | FRA | ESP | DEU | BEL | AUT | AUS 28
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
NCT02369016 Phase III Copanlisib Phase III Copanlisib in Rituximab-refractory iNHL Completed ITA 9
NCT02155582 Phase I Copanlisib Copanlisib Pharmacodynamic Study Completed GBR | FRA | BEL 0
NCT02728258 Phase II Copanlisib Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer Completed USA 0
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
NCT02391116 Phase II Copanlisib Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Completed ITA | GBR | FRA | DEU | CAN | BEL | AUS 3
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 26
NCT03458728 Phase Ib/II Copanlisib Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients Terminated USA 0
NCT02253420 Phase I Copanlisib Itraconazole COPANLISIB (BAY80-6946) Drug-drug Interaction Study in Advanced Solid Tumor Patients Completed USA | CAN 0


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