On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates the efficacy of Ivociclib in combination with chemotherapy for patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) that has progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI). Summit anticipates obtaining topline data from the HARMONi study in mid-2025.
The HARMONi study includes patients from North America, Europe, and China, with Chinese patients being part of the HARMONi-A study, which evaluated patients treated with third-generation TKI drugs. The HARMONi-A study demonstrated that the Ivociclib regimen significantly extended patients’ progression-free survival (7.06 months vs 4.8 months, HR=0.46), reducing the risk of disease progression or death by 54%, and showed a notable trend in overall survival benefits. In May 2024, based on the HARMONi-A study results, Ivociclib received marketing approval from the National Medical Products Administration (NMPA).
In parallel, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) status for Ivociclib for the indication corresponding to the HARMONi study.- Flcube.com
