---
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

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