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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Aliqopa (copanlisib) (PIK3CA inhibitor, PI3Kδ inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
Excerpt:
...Genetic alterations will include PIK3CA gain of function mutations, PIK3R1 loss of function mutations, PTEN loss of function mutations, and PTEN deletions....
Trial ID:
Source:
Title:
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
Excerpt:
...- Patients must have PIK3CA mutation as determined via the MATCH Master Protocol...
Trial ID:
More C2 evidence
Source:
Title:
A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer
Excerpt:
...- Patients must have had tumor sequencing for evaluation of actionable PIK3CA or PTEN mutations performed in a Clinical Laboratory Improvement Act (CLIA) certified, College of American Pathologist (CAP) tested and bioinformatics-validated testing lab PRIOR to enrollment in this current protocol....
Trial ID:
Source:
Title:
Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Excerpt:
...- All patients must have a somatic PIK3CA gene mutation (i.e., R88Q in exon 1, N345K in exon 4, C420R in exon 7, E542K, E545X [E545A, E545D, E545G, and E545K], Q546X [Q546E, Q546K, Q546L, and Q546R] in exon 9, and M1043I, H1047X [H1047L, H1047R, and H1047Y], or G1049R in exon 20) in a representative primary or metastatic tumor sample confirmed by the Roche COBAS PIK3CA Mutation Test at Q^2 Solutions...
Trial ID:
Less C2 evidence
Source:
Title:
Phase II Study of Copanlisib in Patients With Tumors With PIK3CA Mutations: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1F
Published date:
02/08/2022
Excerpt:
Arm Z1F evaluated copanlisib, an α and δ isoform-specific phosphoinositide 3-kinase (PI3K) inhibitor, in patients with PIK3CA mutations (with or without PTEN loss)....The study met its primary end point with an ORR of 16% (P = .0341) with copanlisib showing clinical activity in select tumors with PIK3CA mutation in the refractory setting.
DOI:
10.1200/JCO.21.01648
