Akeso's Ivonescimab Sets New Standards in NSCLC Treatment

Akeso's Groundbreaking Clinical Trial Results

Akeso, Inc. (9926.HK) is thrilled to share significant breakthroughs from its Phase III clinical study of ivonescimab, a cutting-edge PD-1/VEGF bispecific antibody designed to treat non-small cell lung cancer (NSCLC). The study, known as HARMONi-2/AK112-303, has garnered attention following its publication in The Lancet, one of the most prestigious medical journals worldwide.

Impact of The Lancet Publication

The publication of the HARMONi-2 study in The Lancet underscores the academic community's recognition of ivonescimab's potential to transform cancer treatments. Previously, this innovative treatment has been highlighted in prominent journals, showcasing its encouraging efficacy across various types of cancer.

Presentation at World Conference on Lung Cancer

A remarkable presentation at the World Conference on Lung Cancer reiterated the strength of the study results. The principal investigator, Professor Zhou Caicun, an esteemed oncologist and President-Elect of IASLC, emphasized the promising outcomes of the trial. The results indicated that ivonescimab significantly enhances progression-free survival compared to pembrolizumab in patients with locally advanced or metastatic PD-L1 positive NSCLC.

Significant Findings from the HARMONi-2 Study

The HARMONi-2 trial provided crucial insights showing that ivonescimab reduced the risk of disease progression by 49%, a remarkable achievement in the field of oncology. It demonstrated consistent efficacy across various patient demographics, thereby reinforcing its applicability in diverse clinical settings. This marked a historic moment as ivonescimab became the first treatment of its kind to show such a degree of effectiveness in a randomized controlled trial against pembrolizumab.

Review and Approval Status

With its promising results, the supplemental New Drug Application for ivonescimab as a primary treatment for PD-L1 positive NSCLC is currently undergoing review, receiving priority status in China. Additionally, ivonescimab has already been incorporated into the China National Reimbursement Drug List in combination with chemotherapy, facilitating broader access for patients.

Strategic Development Plans for Ivonescimab

Akeso remains dedicated to expanding ivonescimab's role in cancer immunotherapy through a comprehensive development plan. This strategy aims to elevate standards of care globally by continuing to validate the efficacy and safety of ivonescimab through ongoing multicenter clinical trials.

Current and Upcoming Clinical Trials

As part of its initiatives, Akeso is collaborating with Summit Therapeutics on three international Phase III clinical trials:

• The HARMONi study evaluates ivonescimab combined with chemotherapy for patients who have progressed following third-generation EGFR-TKI treatment. This trial has completed patient enrollment and achieved Fast Track Designation from the FDA.
• The HARMONi-3 study focuses on combining ivonescimab with chemotherapy as a first-line treatment for both squamous and non-squamous NSCLC.
• The HARMONi-7 study investigates ivonescimab as a monotherapy for high-expressing PD-L1 NSCLC patients.

In addition to these trials, several more are underway in China:

• Testing ivonescimab with chemotherapy in first-line squamous NSCLC patients.
• Evaluating ivonescimab in biliary tract cancer treatments.
• Investigating its effectiveness in combination with AK117 for head and neck squamous cell carcinoma.
• Exploring treatment options for triple-negative breast cancer.

Conclusion

Akeso's commitment to advancing cancer therapies through innovative approaches is evident in its continuous efforts to integrate ivonescimab into key treatment standards. The promising results from clinical trials highlight its potential to change how non-small cell lung cancer is treated, offering new hope to patients and the medical community alike.

Frequently Asked Questions

What is ivonescimab?

Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, Inc. to treat non-small cell lung cancer.

What were the results of the Phase III clinical trial?

The HARMONi-2 trial demonstrated that ivonescimab significantly improved progression-free survival compared to pembrolizumab.

What does the publication in The Lancet mean?

Being published in The Lancet signifies recognition of ivonescimab’s clinical potential by the international medical community.

Which other cancers besides NSCLC is ivonescimab being studied for?

Ivonescimab is also being evaluated for biliary tract cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer.

What trials are currently ongoing?

Several clinical trials are underway, including studies comparing ivonescimab with chemotherapy for various cancer types.

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