Significant Phase II Breakthrough for Akeso's Ivonescimab in NSCLC

Akeso's Promising Results with Ivonescimab for Lung Cancer

Akeso (9926.HK) has recently announced groundbreaking results from the Phase II study of ivonescimab, a novel PD-1/VEGF bispecific antibody, for treating resectable non-small cell lung cancer (NSCLC). This study was presented during a significant oral session at the 25th World Conference on Lung Cancer (WCLC) and marks ivonescimab's third international presentation in 2024.

Details of the Phase II Study

In the AK112-205 study, a total of 60 patients with NSCLC participated, predominantly in stage III with a strong representation of N+ stage patients. Notably, 70% of the N+ stage patients were classified as N2 stage. Results indicated that 49 of these patients underwent successful surgeries with all R0 resections. The findings were promising—a noteworthy percentage of patients showed pathological complete response (pCR) and major pathological response (MPR) after undergoing treatment with ivonescimab.

Comparison of Treatment Responses

When analyzing the results, the cohort receiving ivonescimab alongside chemotherapy exhibited superior MPR and pCR rates compared to those receiving only ivonescimab. Specifically, the combination treatment yielded an overall pCR rate of 43.6% and an MPR rate of 71.8%. Impressively, as of recent updates, these rates have improved even further, particularly in patients with squamous NSCLC, where pCR and MPR rates soared to 63.6% and 84.1%, respectively.

Safety Profile and Event-Free Survival Emerging Data

The safety profile of ivonescimab was deemed manageable, with no reported treatment-related adverse events (TRAEs) that led to surgery delays or complications. Although Event-Free Survival (EFS) data are still being collected, there is a strong indication of a significant correlation between pCR rates and EFS outcomes, hinting at the potential for positive long-term effects of the treatment.

About Ivonescimab and Its Unique Mechanism

Ivonescimab represents a global first-in-class innovation in bispecific immunotherapy, developed internally by Akeso. It has received regulatory approval in China for specific NSCLC patient demographics and is recognized for its unique dual therapeutic mechanism that combines cancer immunotherapy with anti-angiogenesis.

Global Licensing and Ongoing Studies

Akeso has also entered into a licensing agreement, granting Summit Therapeutics exclusive rights for the development and commercialization of ivonescimab in various territories, including regions such as the United States and Europe. This strategic partnership is expected to enhance the reach of this promising therapy.

Future Directions and Clinical Trials

The journey for ivonescimab continues with several ongoing Phase III trials, including comparisons with pembrolizumab monotherapy and combinations against other treatments for squamous NSCLC. Akeso is pioneering multiple studies across various cancer types, indicating a robust commitment to exploring ivonescimab's full potential.

About Akeso

Founded in 2012, Akeso has evolved into a leading biopharmaceutical company that emphasizes research and innovation in biological medicines. The company boasts an extensive pipeline featuring over 50 innovative assets, evidencing its dedication to addressing critical healthcare challenges effectively.

Commitment to Innovation and Access

With a fully integrated R&D platform, Akeso is well-positioned to continue delivering first-in-class therapeutic solutions. The commitment to developing accessible medicine is at the core of Akeso’s mission, allowing them to serve patients globally and create substantial social and commercial values in the biopharmaceuticals space.

Frequently Asked Questions

What is ivonescimab?

Ivonescimab is a bispecific antibody that targets PD-1 and VEGF, designed for treating non-small cell lung cancer through innovative immunotherapy mechanisms.

What were the findings from the Phase II study?

The Phase II study indicated significant response rates for patients treated with ivonescimab, particularly in combination with chemotherapy, with high rates of pCR and MPR.

What is the safety profile of ivonescimab?

The safety profile for ivonescimab is manageable with no severe adverse events reported that delay surgeries or cause complications.

What’s Akeso’s future direction with ivonescimab?

Akeso is engaged in numerous clinical trials to explore ivonescimab's efficacy across different cancer types and treatment combinations, continuously pushing the boundaries of cancer treatment.

Where is ivonescimab currently approved?

Ivonescimab has been approved in China for specific NSCLC patients and is undergoing further development for broader applications globally.

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