# Afuresertib

Source: https://onco.cc/drugs/afuresertib/  
OnCo record `afuresertib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-11-04
- Also known as: LAE002
- Tags: pipeline; ctgov-ingest
- Code: LAE002
- Modality: Small molecule
- Mechanism: Blocks AKT, a signalling enzyme in the PI3K-AKT pathway that drives cancer cell growth and survival.

## Sources

- Laekna research and development: https://www.laekna.com/rd
- Laekna milestones: https://www.laekna.com/aboutus
- ClinicalTrials.gov NCT04851613: https://clinicaltrials.gov/study/NCT04851613
- ClinicalTrials.gov NCT04060394: https://clinicaltrials.gov/study/NCT04060394
- ClinicalTrials.gov NCT05390710: https://clinicaltrials.gov/study/NCT05390710
- ClinicalTrials.gov NCT04374630: https://clinicaltrials.gov/study/NCT04374630
- ClinicalTrials.gov NCT05383482: https://clinicaltrials.gov/study/NCT05383482

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [AKT](https://onco.cc/targets/akt/)
- companies: [Laekna Therapeutics](https://onco.cc/companies/laekna-therapeutics/)
- trials: [Afuresertib +Sintilimab+Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1](https://onco.cc/trials/nct05383482/), [Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC](https://onco.cc/trials/nct04060394/), [PhI to Solid Tumors and PhII to Locally Advanced or mTNBC](https://onco.cc/trials/nct05390710/), [Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer](https://onco.cc/trials/nct04851613/), [Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian](https://onco.cc/trials/nct04374630/)

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