#Hong Kong #Akeso #Ivonescimab #Pembrolizumab

Akeso's Groundbreaking Announcement on Ivonescimab's Clinical Trial Results

In a significant leap forward for cancer immunotherapy, Akeso, Inc. has revealed the results of its Phase III clinical trial for ivonescimab, a novel PD-1/VEGF bispecific antibody designed for the treatment of non-small cell lung cancer (NSCLC). Published in the esteemed Lancet, the findings compare ivonescimab monotherapy against pembrolizumab, highlighting the former’s superior efficacy in patients with PD-L1 positive tumors.As cancer therapies evolve, the need for effective treatment options becomes urgent. The HARMONi-2 study, which was presented at the 2024 World Conference on Lung Cancer, demonstrates a significant enhancement in progression-free survival (PFS) for patients treated with ivonescimab compared to those receiving pembrolizumab, with a reduction in disease progression risk by 49% (PFS HR 0.51, P<0.0001).

The Clinical Findings

The trial's intent-to-treat population showcased that ivonescimab not only extended survival but also presented consistent outcomes across various subgroups, including different ages, genders, and tumor characteristics. This consistency strengthens the argument for ivonescimab as a crucial component in the fight against NSCLC. Akeso's CEO expressed pride in seeing ivonescimab recognized in such a prestigious journal, affirming the treatment's potential to change the standard of care in immunotherapy.

Continued Research and Next Steps

Aside from its promising Phase III results, ongoing studies involving ivonescimab support its role in a broad spectrum of malignancies. Currently, several international multicenter Phase III clinical trials are underway, exploring ivonescimab combined with chemotherapy for various cancer types, including squamous NSCLC and biliary tract cancer. Notably, ivonescimab has received approval in China for patients with non-squamous NSCLC resistant to EGFR-TKI therapy.

The regulatory submission for ivonescimab as a first-line treatment for PD-L1 positive NSCLC is under review, boasting priority status in China. Akeso’s comprehensive approach aims to reshape cancer treatment paradigms, reinforcing the need for continued innovation in the oncology space.

Conclusion

Akeso's strategic focus on ivonescimab resonates through its impressive clinical findings and expanding research portfolio. As the medical community eagerly anticipates further developments, the publication of these results signals a transformative moment in our approach to fighting lung cancer, with the hope of extending lives and improving outcomes for patients worldwide.