---
title: "LAEKNA-B-B: Topline data released for the combination of AFURESERTIB and paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC) (PROFECTA-II)."
description: "LAEKNA-B has released top-line data on the combination of afuresertib and paclitaxel for the treatment of platinum-resistant ovarian cancer (PROC). According to the results of the clinical trial, the "
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/106871118.md"
published_at: "2024-01-28T11:10:07.000Z"
---

# LAEKNA-B-B: Topline data released for the combination of AFURESERTIB and paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC) (PROFECTA-II).

> LAEKNA-B has released top-line data on the combination of afuresertib and paclitaxel for the treatment of platinum-resistant ovarian cancer (PROC). According to the results of the clinical trial, the combination of afuresertib and paclitaxel demonstrated a significant improvement in progression-free survival in the biomarker-positive subgroup. The safety and tolerability of the combination therapy were manageable. The group plans to discuss the next steps in the regulatory clinical pathway with regulatory authorities.

Zhitong App News: LAEKNA-B (02105) has announced the top-line data of the international multicenter Phase II clinical trial (PROFECTA-II) evaluating the combination of afuresertib and paclitaxel in platinum-resistant ovarian cancer (PROC) patients in the United States and China.

PROFECTA-II study (NCT04374630) is a randomized, open-label, active-controlled Phase II clinical trial that evaluates the efficacy and safety of afuresertib in combination with paclitaxel compared to paclitaxel alone in female patients with platinum-resistant ovarian cancer (PROC). The study enrolled 150 patients in the United States and China, randomized into the experimental group and the control group. The primary endpoint is investigator-assessed progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate, and duration of response.

The trial results showed that the combination of afuresertib and paclitaxel weekly reduced the risk of disease progression or death (PFS), with a hazard ratio (HR) of 0.744 (95% CI: 0.502-1.102), but the trial did not reach statistical significance. In the biomarker-positive subgroup (AKT phosphorylation positive, IHC>1) (37% of patients), data showed that the combination therapy significantly improved PFS, with a median PFS of 5.4 months compared to 2.9 months with paclitaxel alone, with an HR of 0.352 (95% CI: 0.125-0.997). The secondary endpoint of overall survival (OS) also showed a positive trend in the biomarker subgroup. Other secondary endpoints demonstrated that the combination therapy improved objective response rate and longer duration of response. The safety profile of the combination therapy was manageable and tolerable, consistent with the known safety characteristics of the drugs. The group plans to discuss the trial results with regulatory authorities to determine the next steps in the registration clinical pathway. Detailed trial data will be presented at medical conferences.

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