Akeso, Inc. announced that its global first-in-class PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy, has demonstrated strongly positive results in the Phase III clinical trial (AK112-306/HARMONi-6) for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC). The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-free survival (PFS) at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful.
Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year. Data from the HARMONi- 6 study show that, in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS); The ivonescimab combination showed clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations; The trial enrolled a total of 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, a distribution consistent with real-world patient populations; Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified. The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group.
The HARMONi-6 study is ivonescimab's third Phase III clinical trial with positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC. The HARMONi- 6 study is also ivonescimab's second Phase III clinical trial with positive Results in lung cancer in head-to-head comparisons vs. PD-1 inhibitors, further establishing ivonescimab as a comprehensive treatment option for both first-line and later-line NSCLC.
This result further positions ivonescimab to improve upon and replace the current standard of care for the treatment of NSCLC. This breakthrough not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy. The interim analysis results from the HARMONi -6 study show that ivonescimab in combination with chemotherapy significantly prolonged progression-free survival (P FS) compared to tislelizumab with chemotherapy.
In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This highlights its potential to overcome the limitations of bevACizumab in treating squ Famous non-small cell lung cancer, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma.
