#Hong Kong #Akeso #Ivonescimab #SCLC

Akeso Initiates Phase III Clinical Trial for Ivonescimab

Akeso, Inc., a prominent player in the biopharmaceutical industry, has made a groundbreaking announcement regarding the initiation of its Phase III clinical trial for Ivonescimab, a pioneering PD-1/VEGF bispecific antibody. This trial is particularly vital as it aims to assess the efficiency of Ivonescimab as a consolidation therapy for patients with limited-stage small cell lung cancer (LS-SCLC) who have not encountered any progression following standard concurrent chemoradiotherapy (cCRT).

Small cell lung cancer accounts for about 15% of lung cancer cases and is notorious for its aggressive behavior and poor prognosis, particularly in patients who are not surgical candidates. Particularly concerning is that over 80% of diagnosed individuals with LS-SCLC do not qualify for surgery, compelling the need for effective therapeutic strategies. The challenge with the current standard of care is that most patients experience disease recurrence or develop resistance to available therapies. Ivonescimab’s introduction offers a much-needed hope as there's only one currently approved PD-L1 therapy for consolidation treatment in LS-SCLC, highlighting the critical unmet clinical need.

The study, labeled AK112-311/HARMONi-9, represents Akeso's eighth registrational Phase III clinical trial focused on Ivonescimab, underscoring the drug's potential across multiple indications in lung cancer. Prior studies have demonstrated its capability to enhance progression-free survival (PFS) in extensive-stage SCLC (ES-SCLC) by leveraging the synergistic effects of PD-1/L1 inhibitors in combination with anti-angiogenic agents. As the first drug of its class, Ivonescimab is set to innovate the landscape of lung cancer treatment, indicating a transformational potential that could substantially improve how lung cancer is managed globally.

Akeso’s strategy, termed