{"entity":{"id":"afuresertib","kind":"drug","name":"Afuresertib","aka":["LAE002"],"tldr":"Afuresertib is an experimental pill from Laekna Therapeutics, in phase 3 trials for HR-positive, HER2-negative breast cancer.","summary":"Afuresertib (LAE002) is a small molecule from Laekna Therapeutics. Blocks AKT, a signalling enzyme in the PI3K-AKT pathway that drives cancer cell growth and survival. Laekna licensed it from Novartis in 2018. The company says the phase 3 AFFIRM-205 study of afuresertib with fulvestrant in HR-positive, HER2-negative breast cancer (NCT04851613) met its primary endpoint in April 2026 and that China's NMPA accepted a new drug application in August 2026; China breast cancer rights were licensed to Qilu Pharmaceutical in November 2025. Earlier studies covered metastatic castration-resistant prostate cancer, triple-negative breast cancer, platinum-resistant ovarian cancer, non-small cell lung cancer and cervical cancer.","status":"phase-3","asOf":"2026-11-04","links":[{"label":"Laekna research and development","url":"https://www.laekna.com/rd"},{"label":"Laekna milestones","url":"https://www.laekna.com/aboutus"},{"label":"ClinicalTrials.gov NCT04851613","url":"https://clinicaltrials.gov/study/NCT04851613"},{"label":"ClinicalTrials.gov NCT04060394","url":"https://clinicaltrials.gov/study/NCT04060394"},{"label":"ClinicalTrials.gov NCT05390710","url":"https://clinicaltrials.gov/study/NCT05390710"},{"label":"ClinicalTrials.gov NCT04374630","url":"https://clinicaltrials.gov/study/NCT04374630"},{"label":"ClinicalTrials.gov NCT05383482","url":"https://clinicaltrials.gov/study/NCT05383482"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate-mcrpc","tnbc","ovarian"],"sections":[],"technologies":[],"targets":["akt"],"drugs":[],"companies":["laekna-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04851613","nct04060394","nct05390710","nct04374630","nct05383482"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors, investor portfolios (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-04"},"code":"LAE002","modality":"Small molecule","mechanism":"Blocks AKT, a signalling enzyme in the PI3K-AKT pathway that drives cancer cell growth and survival.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/afuresertib/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"akt","kind":"target","name":"AKT","route":"/targets/akt/"}],"company":[{"id":"laekna-therapeutics","kind":"company","name":"Laekna Therapeutics","route":"/companies/laekna-therapeutics/"}],"trial":[{"id":"nct05383482","kind":"trial","name":"Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1","route":"/trials/nct05383482/"},{"id":"nct04060394","kind":"trial","name":"Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC","route":"/trials/nct04060394/"},{"id":"nct05390710","kind":"trial","name":"PhI to Solid Tumors and PhII to Locally Advanced or mTNBC","route":"/trials/nct05390710/"},{"id":"nct04851613","kind":"trial","name":"Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer","route":"/trials/nct04851613/"},{"id":"nct04374630","kind":"trial","name":"Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian","route":"/trials/nct04374630/"}]}}