Akeso’s Phase 3 Trial: A Potential Game-Changer in NSCLC Treatment

Akeso, Inc. ((HK:9926)) announced an update on their ongoing clinical study.

Akeso, Inc. is spearheading a pivotal Phase 3 clinical trial titled A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy. The study aims to assess the efficacy and safety of ivonescimab, in combination with docetaxel, compared to a placebo with docetaxel in treating advanced NSCLC, a significant concern in oncology.

The intervention involves the administration of ivonescimab, a novel drug, alongside docetaxel, a chemotherapy agent, to evaluate its potential in improving outcomes for NSCLC patients who have not responded to prior PD-(L)1 inhibitor-based therapies.

This randomized, double-blind study employs a parallel intervention model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary goal is treatment-focused, aiming to provide new therapeutic options for NSCLC.

The study is slated to begin on April 8, 2025, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on April 29, 2025, indicating the study’s progression towards recruitment.

The initiation of this study could influence Akeso’s stock performance positively, as successful outcomes may enhance its market position in the oncology sector. Investors should watch for developments in this trial, as positive results could shift competitive dynamics in NSCLC treatment.

The study is ongoing, with further details available on the ClinicalTrials portal.