---
title: "LAEKNA achieved significant improvement in PFS, reaching the primary endpoint in Phase III clinical trial for breast cancer"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/282760338.md"
description: "LAEKNA announced that its Phase III clinical trial (AFFIRM-205) achieved positive results, showing a significant improvement in progression-free survival (PFS) for LAE002 (afuresertib) combined with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer. The study was a multicenter, randomized, double-blind, placebo-controlled trial that included 261 subjects, 70.5% of whom had previously received CDK4/6 inhibitor treatment"
datetime: "2026-04-15T00:27:23.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/282760338.md)
  - [en](https://longbridge.com/en/news/282760338.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/282760338.md)
---

# LAEKNA achieved significant improvement in PFS, reaching the primary endpoint in Phase III clinical trial for breast cancer

LAEKNA-B (02105.HK) announced that the Phase III clinical trial "Phase III Clinical Trial (AFFIRM-205)" of LAE002 (afuresertib) in combination with Fulvestrant, conducted in HR+/HER2- locally advanced or metastatic breast cancer ("LA/mBC") patients who experienced disease progression after prior treatment with endocrine therapy with or without CDK4/6 inhibitors, and with PIK3CA/AKT1/PTEN alterations, has achieved strong positive top-line results.

This pivotal study successfully met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the control group.

The Phase III Clinical Trial (AFFIRM-205) is a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the antitumor efficacy and safety of this combination therapy. A total of 261 subjects were included, of which 70.5% had previously received CDK4/6 inhibitor treatment

### Related Stocks

- [02105.HK](https://longbridge.com/en/quote/02105.HK.md)
- [159102.CN](https://longbridge.com/en/quote/159102.CN.md)
- [512290.CN](https://longbridge.com/en/quote/512290.CN.md)
- [159859.CN](https://longbridge.com/en/quote/159859.CN.md)
- [520500.CN](https://longbridge.com/en/quote/520500.CN.md)
- [516500.CN](https://longbridge.com/en/quote/516500.CN.md)
- [516820.CN](https://longbridge.com/en/quote/516820.CN.md)
- [513120.CN](https://longbridge.com/en/quote/513120.CN.md)
- [516930.CN](https://longbridge.com/en/quote/516930.CN.md)
- [159849.CN](https://longbridge.com/en/quote/159849.CN.md)
- [159570.CN](https://longbridge.com/en/quote/159570.CN.md)
- [560600.CN](https://longbridge.com/en/quote/560600.CN.md)
- [588860.CN](https://longbridge.com/en/quote/588860.CN.md)
- [588250.CN](https://longbridge.com/en/quote/588250.CN.md)
- [159837.CN](https://longbridge.com/en/quote/159837.CN.md)
- [FBT.US](https://longbridge.com/en/quote/FBT.US.md)
- [159615.CN](https://longbridge.com/en/quote/159615.CN.md)
- [562050.CN](https://longbridge.com/en/quote/562050.CN.md)

## Related News & Research

- [Analyst Reiterates Buy on Microbix, Citing Temporary China Slowdown and Growing Diversified Demand](https://longbridge.com/en/news/286665358.md)
- [Wuxi AppTec to Raise Around $1 Billion Through Zero Coupon Convertible Bonds](https://longbridge.com/en/news/286487023.md)
- [JD Health files HKEX return disclosing share buyback at HKD 40.3 each](https://longbridge.com/en/news/287057883.md)
- [Manulife Singapore to offer multi-cancer blood test starting May](https://longbridge.com/en/news/286710691.md)
- [20:03 ETHarbour BioMed Announces Promising Preclinical Data for LET003, Its First AI-Enabled Drug Candidate](https://longbridge.com/en/news/286688082.md)