Akeso’s Ivonescimab Shines in Phase III Clinical Study: A New Hope for NSCLC Patients
HONG KONG, March 7, 2025 – Akeso, Inc. (9926.HK), a leading biopharmaceutical company, is thrilled to share the groundbreaking findings of its Phase III clinical study, HARMONi-2/AK112-303, which compared the efficacy and safety of ivonescimab, its first-in-class PD-1/VEGF bispecific antibody, as a monotherapy to pembrolizumab monotherapy in the first-line treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).
A Game-Changer for NSCLC Patients
The publication of these results in The Lancet, a renowned international medical journal, is a significant milestone for Akeso and a testament to the academic community’s recognition of ivonescimab’s potential as a breakthrough treatment for NSCLC patients. The HARMONi-2 study demonstrated that ivonescimab outperformed pembrolizumab in terms of progression-free survival (PFS) and overall response rate (ORR), offering a new hope for patients with this devastating disease.
Ivonescimab’s Clinical Superiority
The trial included 529 patients randomly assigned to receive either ivonescimab or pembrolizumab. The results showed that ivonescimab provided a statistically significant improvement in PFS (11.1 vs. 6.7 months; hazard ratio [HR] 0.55, 95% CI 0.44-0.69; p<0.0001) and ORR (67.2% vs. 48.2%; odds ratio [OR] 1.93, 95% CI 1.41-2.66; p<0.0001).
Implications for Patients
For NSCLC patients, the HARMONi-2 study results could mean a more effective and potentially curative treatment option. Ivonescimab’s dual mechanism of action, targeting both PD-1 and VEGF, may provide a more comprehensive approach to treating NSCLC compared to current monotherapies like pembrolizumab.
Global Impact
The publication of the HARMONi-2 study in The Lancet not only represents a significant achievement for Akeso but also for the global oncology community. The potential of ivonescimab to offer a more effective treatment option for NSCLC patients could lead to improved patient outcomes and reduced healthcare costs associated with managing advanced NSCLC.
Looking Ahead
The successful completion of the HARMONi-2 study marks an important step forward for Akeso as it moves towards regulatory approval and commercialization of ivonescimab. The company plans to submit the data to regulatory agencies in the coming months, with potential for approval and market launch in the near future.
- Akeso’s ivonescimab demonstrates clinical superiority in Phase III study.
- Publication in The Lancet signifies academic recognition of ivonescimab’s potential.
- Ivonescimab’s dual mechanism of action offers a more comprehensive approach to NSCLC treatment.
- Improved patient outcomes and reduced healthcare costs are potential benefits of ivonescimab.
- Akeso plans to submit data to regulatory agencies for approval and market launch.
Conclusion
The HARMONi-2 study results, published in The Lancet, represent a significant breakthrough in the treatment of NSCLC. Akeso’s ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown clinical superiority compared to pembrolizumab, offering a more effective and potentially curative treatment option for PD-L1 positive NSCLC patients. The publication in The Lancet is a strong recognition by the academic community of ivonescimab’s potential to improve patient outcomes and reduce healthcare costs associated with managing advanced NSCLC. Akeso is moving forward with regulatory approval and commercialization plans, bringing this groundbreaking treatment to market in the near future.
