{"entity":{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","aka":[],"tldr":"PIK3CA is the most commonly mutated gene in hormone-driven breast cancer. Drugs against it work, but hitting it cleanly without raising blood sugar took years.","summary":"PIK3CA mutations occur in ~40% of HR+ breast cancer. Alpelisib (SOLAR-1), inavolisib (INAVO120, mutant-selective, with palbociclib and fulvestrant), and capivasertib (AKT) are approved. Gedatolisib (pan-PI3K/mTOR, Revtorpyk) was approved in 2026. Mutant-selective and allosteric inhibitors (RLY-2608) aim to avoid hyperglycaemia.","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/P110α","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/P110α"}],"tags":["driver","kinase"],"related":["pik3ca-hotspot-mutation"],"cancers":["breast-hr-positive","endometrial","head-and-neck","tnbc","colorectal","gallbladder","nsclc","prostate"],"sections":[],"technologies":["pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["therascreen-cdx","tersolisib","zovegalisib","serabelisib"],"companies":["bridgebio-oncology-therapeutics","cogent-biosciences","relay-therapeutics","scorpion-therapeutics"],"institutions":[],"pathways":["pi3k-akt-mtor","breast-cancer-signalling","chemical-carcinogenesis-receptor-activation","colorectal-cancer-signalling","endometrial-cancer-signalling","gastric-cancer-signalling","glioma-signalling","pancreatic-cancer-signalling"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-tcga-breast-molecular-portraits-nature-2012","paper-bareche-tnbc-multiomic-heterogeneity-ann-oncol-2018","paper-jiang-fuscc-tnbc-landscape-cancer-cell-2019","paper-narayan-gallbladder-regional-mutations-cancer-2019","paper-giraldo-gallbladder-msk-impact-ccr-2022","paper-kris-lung-cancer-mutation-consortium-jama-2014","paper-tcga-lung-squamous-nature-2012","paper-tcga-molecular-taxonomy-primary-prostate-cell-2015","paper-carver-pi3k-ar-reciprocal-feedback-prostate-cancer-cell-2011"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer: hotspot mutation in 20 to 28% (E545K, H1047R and E542K the commonest), enriched on the right (32.4% against 15.5%) and in mismatch repair deficient tumours (45.2% against 17.6%; cBioPortal). No PI3K or AKT inhibitor is approved in this disease; the interest is as a co-mutation that blunts EGFR antibody benefit and as the basis of the aspirin hypothesis.","Lung cancer: hotspot mutated in 5 to 7% of adenocarcinomas, where it is usually a passenger alongside a real driver, and in 11 to 16% of squamous tumours with high-level amplification on top in 37.8%, part of the 3q26 gain that also carries SOX2 (cBioPortal). The pathway was altered in 47% of squamous tumours in the founding analysis and has the longest record of failed trials in that histology (Cancer Genome Atlas Research Network 2012)."],"symbol":"PIK3CA","role":[],"sources":[],"specificity":"tumour-specific","distribution":"many-types","specificityNote":"Tumour-specific alteration: 1 of 1 label readouts filed under it measure a sequence variant (PIK3CA mutation) absent from normal cells. HPA PIK3CA: RNA low tissue specificity; high antibody staining in 20 normal tissues; highest cancer staining colorectal cancer (11 of 12 high). Distribution: 5 cancer families in the corpus carry a prevalence row, label threshold or catalogue link for it (Breast cancer (all types), Endometrial cancer, Head and neck squamous cell carcinoma, Biliary tract cancer (all types), Colorectal cancer); approvals of single-target medicines aimed at it also list Lymphoma, Leukaemia, not counted; Open Targets associates it with 23 specific cancer types at or above 0.5 (CLOVES syndrome, breast cancer, ovarian cancer, breast adenocarcinoma, hepatocellular carcinoma, non-small cell lung carcinoma and more). (Rule 3 of scripts/fetch-target-specificity.ts.)","specificitySources":[{"label":"PIK3CA mutation label threshold","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b20b4e18-7a4b-4500-a08f-06c6dab0ee5b","note":"PIK3CA-mutated"},{"label":"Human Protein Atlas PIK3CA tissue","url":"https://www.proteinatlas.org/ENSG00000121879-PIK3CA/tissue","note":"RNA tissue and blood lineage specificity, normal tissue antibody staining (version 25.1, CC BY-SA 3.0)"},{"label":"Open Targets ENSG00000121879 associations","url":"https://platform.opentargets.org/target/ENSG00000121879/associations","note":"cancer associations at or above 0.5 (CC0)"}],"hgnc":"HGNC:8975","ensembl":"ENSG00000121879","uniprot":"P42336","entrez":"5290","firstDescribed":1994,"firstDescribedBasis":"sequence","firstDescribedNote":"Earliest sequence paper UniProt cites for the protein: Volinia et al, Genomics, 1994, \"Molecular cloning, cDNA sequence, and chromosomal localization of the human phosphatidylinositol 3-kinase p110 alpha (PIK3CA) gene\".","firstDescribedSource":"https://pubmed.ncbi.nlm.nih.gov/7713498/","biology":"PIK3CA encodes the catalytic subunit of PI3K; H1047R and E545K are the hotspots.","whereFound":["HR+ breast cancer (~40%)","Endometrial","Head and neck","Colorectal","Triple-negative breast cancer: mutation (amplification in a further tenth) 10-18%","Colorectal cancer: hotspot mutation (e542k, e545k, h1047r) 20-28%","Gallbladder cancer: mutation about 11%","Non-small-cell lung cancer: hotspot mutation (e545k, e542k, h1047r) 5-7%","Non-small-cell lung cancer: hotspot mutation and high-level amplification 11-38%","Prostate cancer: activating mutation, plus amplification of pik3ca or pik3cb 2-9% depending on disease state"],"targetClass":"kinase","prevalence":[{"cancerId":"breast-hr-positive","pct":"35-40","measure":"Activating mutation","source":"https://www.cbioportal.org/study/summary?id=brca_tcga_pan_can_atlas_2018"},{"cancerId":"endometrial","pct":"45-55","measure":"Activating mutation","source":"https://www.cbioportal.org/study/summary?id=ucec_tcga_pan_can_atlas_2018"},{"cancerId":"head-and-neck","pct":"15-20","measure":"Activating mutation","source":"https://www.cbioportal.org/study/summary?id=hnsc_tcga_pan_can_atlas_2018","note":"HPV+ enriched"},{"cancerId":"colorectal","pct":"15-20","measure":"Activating mutation","source":"https://www.cbioportal.org/study/summary?id=coadread_tcga_pan_can_atlas_2018"},{"cancerId":"tnbc","pct":"10-18","measure":"Mutation (amplification in a further tenth)","source":"https://doi.org/10.1038/nature11412","note":"9% of basal-like tumours (Cancer Genome Atlas 2012); 20% of 447 sequenced TNBCs, 55% within the LAR subtype (Bareche 2018); cBioPortal: 9 of 84, 10.7%, in brca_tcga_pub and 14 of 123, 11.4%, on the 2018 calls; 53 of 299, 17.7%, in brca_metabric; 23 of 176, 13.1%, in breast_msk_2018. PIK3CA amplification in 10 of 119, 8.4%, (brca_tcga_pan_can_atlas_2018) and 34 of 320, 10.6%, (brca_metabric)."},{"cancerId":"colorectal","pct":"20-28","measure":"Hotspot mutation (E542K, E545K, H1047R)","source":"https://www.cbioportal.org/study/summary?id=crc_msk_2026","note":"cBioPortal: 1,486 of 7,237, 20.5%, in crc_msk_2026 (E545K 331, H1047R 232, E542K 216 samples); 229 of 1,134, 20.2%, in crc_msk_2017; 298 of 1,516, 19.7%, in crc_eo_2020; 147 of 534, 27.5%, in coadread_tcga_pan_can_atlas_2018; 45 of 224, 20.1%, in coadread_tcga_pub; 132 of 619, 21.3%, in coadread_dfci_2016; 130 of 1,015, 12.8%, in crc_sysucc_2022."},{"cancerId":"gallbladder","pct":11,"measure":"Mutation","source":"https://www.cbioportal.org/study/summary?id=gbc_mskcc_2022","note":"Mutation in 26 of 244 samples, 10.7%, in cBioPortal gbc_mskcc_2022 and 11 of 103, 10.7%, in gbc_msk_2018; 6.2% of 32 exomes in gbc_shanghai_2014; absent from the 11 Japanese tumours in Narayan 2019; named among the actionable variants in 35% of patients (Giraldo 2022)."},{"cancerId":"nsclc","pct":"5-7","measure":"Hotspot mutation (E545K, E542K, H1047R)","source":"https://www.cbioportal.org/study/summary?id=luad_mskcc_2023_met_organotropism","note":"cBioPortal: 159 of 2,653, 6.0%, in luad_mskcc_2023_met_organotropism (E545K 53, E542K 20, H1047R 16 records); 65 of 915, 7.1%, in lung_msk_2017; 28 of 566, 4.9%, in luad_tcga_pan_can_atlas_2018; 12 of 302, 4.0%, in luad_oncosg_2020. It was the driver in 6 of 733 fully genotyped adenocarcinomas, under 1% (Kris 2014)."},{"cancerId":"nsclc","pct":"11-38","measure":"Hotspot mutation and high-level amplification","source":"https://www.cbioportal.org/study/summary?id=lusc_tcga_pan_can_atlas_2018","note":"cBioPortal: mutation in 53 of 484, 11.0%, plus high-level amplification in 184 of 487, 37.8%, in lusc_tcga_pan_can_atlas_2018; mutation 28 of 178, 15.7%, plus amplification 68 of 178, 38.2%, in lusc_tcga_pub; mutation 11 of 108, 10.2%, in lusc_cptac_2021; amplification 208 of 1,144, 18.2%, in nsclc_tcga_broad_2016. E545K (13 records) and E542K (13) lead, with H1047R (5) behind, the reverse of the breast cancer pattern. PTEN is mutated in 51 of 484, 10.5%, with deep deletion in 48 of 487, 9.9%. The founding paper counted the phosphatidylinositol-3-kinase pathway altered in 47% of tumours (Cancer Genome Atlas Research Network 2012)."},{"cancerId":"prostate","pct":"2-9","measure":"Activating mutation, plus amplification of PIK3CA or PIK3CB","source":"https://www.cbioportal.org/study/summary?id=prostate_msk_2024","note":"cBioPortal mutation: PIK3CA 110 of 2,260, 4.9%, in prostate_msk_2024; 24 of 424, 5.7%, in prad_mcspc_mskcc_2020; 14 of 444, 3.2%, in prad_su2c_2019; 10 of 494, 2.0%, in prad_tcga_pan_can_atlas_2018. PIK3CB mutation 31 of 2,260, 1.4%, with amplification 17; AKT1 mutation 42 of 2,260, 1.9%. PIK3CA hotspot records in prostate_msk_2024: E545K 18, E542K 16, H1047R 12 of 116 records. The TCGA taxonomy paper counted a presumed actionable lesion in the PI3K or MAPK pathways in 25% of 333 primary tumours once PTEN was included (Cancer Genome Atlas Research Network 2015)."}]},"route":"/targets/pik3ca/","neighbours":{"biomarker":[{"id":"pik3ca-hotspot-mutation","kind":"biomarker","name":"PIK3CA mutation","route":"/biomarkers/pik3ca-hotspot-mutation/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"erdheim-chester-disease","kind":"cancer","name":"Erdheim-Chester disease","route":"/cancers/erdheim-chester-disease/"},{"id":"histiocytoses","kind":"cancer","name":"Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms","route":"/cancers/histiocytoses/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder 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inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"id":"capivasertib","kind":"drug","name":"Capivasertib","route":"/drugs/capivasertib/"},{"id":"copanlisib","kind":"drug","name":"Copanlisib","route":"/drugs/copanlisib/"},{"id":"duvelisib","kind":"drug","name":"Duvelisib","route":"/drugs/duvelisib/"},{"id":"everolimus","kind":"drug","name":"Everolimus","route":"/drugs/everolimus/"},{"id":"gedatolisib","kind":"drug","name":"Gedatolisib","route":"/drugs/gedatolisib/"},{"id":"idelalisib","kind":"drug","name":"Idelalisib","route":"/drugs/idelalisib/"},{"id":"inavolisib","kind":"drug","name":"Inavolisib","route":"/drugs/inavolisib/"},{"id":"serabelisib","kind":"drug","name":"Serabelisib","route":"/drugs/serabelisib/"},{"id":"tersolisib","kind":"drug","name":"Tersolisib","route":"/drugs/tersolisib/"},{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","route":"/drugs/therascreen-cdx/"},{"id":"umbralisib","kind":"drug","name":"Umbralisib","route":"/drugs/umbralisib/"},{"id":"zovegalisib","kind":"drug","name":"Zovegalisib","route":"/drugs/zovegalisib/"}],"company":[{"id":"bridgebio-oncology-therapeutics","kind":"company","name":"BridgeBio Oncology Therapeutics","route":"/companies/bridgebio-oncology-therapeutics/"},{"id":"cogent-biosciences","kind":"company","name":"Cogent Biosciences","route":"/companies/cogent-biosciences/"},{"id":"recursion","kind":"company","name":"Recursion Pharmaceuticals","route":"/companies/recursion/"},{"id":"relay-therapeutics","kind":"company","name":"Relay Therapeutics","route":"/companies/relay-therapeutics/"},{"id":"scorpion-therapeutics","kind":"company","name":"Scorpion Therapeutics","route":"/companies/scorpion-therapeutics/"}],"pathway":[{"id":"bcr-abl1-signalling","kind":"pathway","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/pathways/bcr-abl1-signalling/"},{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"},{"id":"cancer-metabolism","kind":"pathway","name":"Cancer metabolism","route":"/pathways/cancer-metabolism/"},{"id":"chemical-carcinogenesis-receptor-activation","kind":"pathway","name":"Chemical carcinogenesis - receptor activation","route":"/pathways/chemical-carcinogenesis-receptor-activation/"},{"id":"immune-desert-exclusion","kind":"pathway","name":"Cold tumours: immune deserts and exclusion","route":"/pathways/immune-desert-exclusion/"},{"id":"colorectal-cancer-signalling","kind":"pathway","name":"Colorectal cancer (KEGG map)","route":"/pathways/colorectal-cancer-signalling/"},{"id":"endometrial-cancer-signalling","kind":"pathway","name":"Endometrial cancer (KEGG map)","route":"/pathways/endometrial-cancer-signalling/"},{"id":"fgfr-signalling","kind":"pathway","name":"FGF / FGFR signalling","route":"/pathways/fgfr-signalling/"},{"id":"gastric-cancer-signalling","kind":"pathway","name":"Gastric cancer (KEGG map)","route":"/pathways/gastric-cancer-signalling/"},{"id":"glioma-signalling","kind":"pathway","name":"Glioma (KEGG map)","route":"/pathways/glioma-signalling/"},{"id":"intravasation-ctc-survival","kind":"pathway","name":"Intravasation & circulating tumour cells","route":"/pathways/intravasation-ctc-survival/"},{"id":"mrna-translation-eif4f","kind":"pathway","name":"mRNA translation (eIF4F / mTOR)","route":"/pathways/mrna-translation-eif4f/"},{"id":"er-signaling","kind":"pathway","name":"Oestrogen receptor signalling","route":"/pathways/er-signaling/"},{"id":"pancreatic-cancer-signalling","kind":"pathway","name":"Pancreatic cancer (KEGG map)","route":"/pathways/pancreatic-cancer-signalling/"},{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"},{"id":"proteoglycans-in-cancer","kind":"pathway","name":"Proteoglycans in cancer","route":"/pathways/proteoglycans-in-cancer/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"},{"id":"resistance-routes-map","kind":"pathway","name":"Resistance routes: how a blocked pathway comes back","route":"/pathways/resistance-routes-map/"}],"paper":[{"id":"paper-vogelstein-cancer-genome-landscapes-science-2013","kind":"paper","name":"Cancer genome landscapes: about 140 driver genes, and each tumour needs only a handful","route":"/key-papers/paper-vogelstein-cancer-genome-landscapes-science-2013/"},{"id":"paper-schmid-pakt-capivasertib-tnbc-jco-2020","kind":"paper","name":"Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT 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CDK4/6)","route":"/pairings/pi3k-pathway-plus-endocrine/"}],"person":[{"id":"fabrice-andre","kind":"person","name":"Fabrice André","route":"/people/fabrice-andre/"},{"id":"komal-jhaveri","kind":"person","name":"Komal Jhaveri","route":"/people/komal-jhaveri/"},{"id":"ramon-parsons","kind":"person","name":"Ramon E. Parsons","route":"/people/ramon-parsons/"},{"id":"yardena-samuels","kind":"person","name":"Yardena Samuels","route":"/people/yardena-samuels/"}],"idea":[{"id":"idea-reg-aspirin-pik3ca-implementation","kind":"idea","name":"Get biomarker-directed aspirin after colorectal surgery into labels and guidelines","route":"/ideas/idea-reg-aspirin-pik3ca-implementation/"}],"institution":[{"id":"vanderbilt-ingram","kind":"institution","name":"Vanderbilt-Ingram Cancer Center","route":"/institutions/vanderbilt-ingram/"}]}}