Akeso Completes Patient Enrollment for Phase III Trial of Ivonescimab

Akeso Completes Patient Enrollment in Landmark Trial

Akeso, Inc. (9926.HK) is thrilled to share that it has successfully concluded patient enrollment in the pivotal HARMONi-6/AK112-306 clinical trial. This ambitious Phase III study is dedicated to comparing ivonescimab, a groundbreaking PD-1/VEGF bispecific antibody developed by Akeso, with tislelizumab, a PD-1 inhibitor, both in conjunction with platinum-based chemotherapy. This first-line therapy aims to tackle squamous non-small cell lung cancer (sq-NSCLC).

Broadening the Scope of Cancer Immunotherapy

This trial is part of a larger initiative wherein several international Phase III clinical studies are being simultaneously conducted with ivonescimab. One notable trial is the HARMONi-3 study, which juxtaposes ivonescimab with chemotherapy against pembrolizumab combined with chemotherapy, targeting both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). Summit Therapeutics plays a vital role in conducting this trial, serving as Akeso's global partner.

Significance of HARMONi-6/AK112-306 Trial

Among various registrational and Phase III studies globally, the HARMONi-6 trial stands out as it employs PD-1/L1 inhibitors in its comparisons. It marks a crucial milestone in the evolution of cancer immunotherapy, with the aim of establishing advanced treatment protocols while optimizing the clinical and commercial viability of ivonescimab in Akeso's innovative treatment lineup.

Ivonescimab's Approval and Future Potential

Ivonescimab, when paired with chemotherapy, has already received approval in numerous areas for treating EGFR-TKI-resistant, non-squamous NSCLC. Currently, a supplemental New Drug Application (sNDA) is under review, assessing ivonescimab as a monotherapy for first-line PD-L1-positive NSCLC as a competitor to pembrolizumab, a development granted priority status.

A Next-Generation Immunotherapy

ivonescimab is gaining traction as a next-generation immunotherapy, with ongoing Phase III trials targeting various cancer types beyond lung cancer. The treatment is currently being researched for first-line applications in head and neck squamous carcinoma, biliary tract cancer, and pancreatic cancer. Additionally, it is undergoing clinical trials for the first-line treatment of multiple cancer types, including triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer, and gastric cancer.

Addressing Unmet Medical Needs

Current statistics reveal that the yearly incidence of advanced, driver gene-negative sq-NSCLC surpasses 520,000 cases, with numerous patients unable to access anti-angiogenesis therapies like bevacizumab. Even though PD-1/L1 inhibitors combined with chemotherapy have become the standard of care, the outlook for these patients often remains bleak, emphasizing a critical gap in treatment options available. Clinical research suggests that ivonescimab, which is effective in targeting both PD-1 and VEGF, could offer promising anti-tumor effects while maintaining a favorable safety profile. It stands out as a potentially safer alternative for sq-NSCLC patients at risk of complications from traditional therapies.

Changing the Landscape of Cancer Treatment

With its innovative approach, ivonescimab is set to revolutionize first-line treatment strategies for locally advanced or metastatic sq-NSCLC. It promises to provide a more effective and safer immunotherapy alternative, potentially setting new standards in cancer care.

Frequently Asked Questions

What is the primary focus of the HARMONi-6 study?

The HARMONi-6 study primarily focuses on evaluating the effectiveness of ivonescimab combined with chemotherapy compared to tislelizumab combined with chemotherapy for treating squamous non-small cell lung cancer.

What is ivonescimab?

Ivonescimab is an innovative PD-1/VEGF bispecific antibody developed by Akeso, designed to enhance the performance of immunotherapy treatments for various cancers.

What other cancer types are being studied with ivonescimab?

In addition to lung cancer, ivonescimab is under investigation for its potential effectiveness in treating head and neck squamous carcinoma, biliary tract cancer, pancreatic cancer, and several other malignancies.

Why is ivonescimab significant for sq-NSCLC patients?

Ivonescimab is significant for sq-NSCLC patients as it addresses a critical unmet need, offering an alternative treatment that targets both PD-1 and VEGF, potentially improving safety and effectiveness compared to existing therapies.

What are the next steps for ivonescimab?

Following the completion of patient enrollment, further clinical trials and evaluations will be conducted to gather comprehensive efficacy and safety data, aiming for broader regulatory approvals and improved patient outcomes.

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