For Subset of Patients Previously Receiving 3rd Generation EGFR-TKI: PFS Hazard Ratio of 0.48 5.6% treatment Discontinuation of Ivonescimab due to Adverse Events vs.
2.5% Treatment Discontinuation of Placebo HARMONi-A to be Featured in Oral Presentation at ASCO 2024 Today, May 31, 2024 at 4:57pm CT HARMONi-A Manuscript Published in JAMA HONG KONG, May 31, 2024 /PRNewswire/ -- Akeso, Inc. (the Company, Akeso, 9926) announced that, on May 24, 2024, Akeso received marketing authorization in China from the National Medical Products Administration (NMPA).
The approval is based on the positive dataset associated with HARMONi-A, a single region, multi-center, Phase III study conducted in China sponsored by Akeso. HARMONi-A evaluated ivonescimab combined with platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics. This data and trial are separate and distinct from the Phase III HARM.
