Akeso, Inc.announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, in small cell lung cancer (SCLC). This study is designed to assess the efficacy and safety of ivonescimab as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced progression following standard concurrent chemoradiotherapy (cCRT).

AK112-311/HARMONi-9 study is the eighth registrational Phase III clinical trial for ivonescimab in lung cancer (including three international multicenter studies). The initiation of this trial further expands ivonescimab's therapeutic coverage across key lung cancer indications and different lines of treatment. As the world's first PD-1/VEGF bispecific antibody, ivonescimab is driving significant transformation in the overall lung cancer treatment landscape and holds the potential to fundamentally improve global lung cancer therapies.

Small cell lung cancer (SCLC) represents approximately 15% of all lung cancers and is known for its aggressive nature, early metastasis, and poor prognosis. Around 30% of patients are diagnosed at the limited stage (LS-SCLC), with over 80% being ineligible for surgical intervention. The current standard of care involves concurrent or sequential chemoradiotherapy (cCRT/sCRT), where most patients face recurrence or develop drug resistance. To date, only one PD-L1 therapy has been approved for consolidation treatment for LS-SCLC, highlighting the significant unmet clinical need of this difficult to treat cancer.

In previous studies focused on extensive-stage SCLC (ES-SCLC), ivonescimab has demonstrated its ability to prolong progression-free survival (PFS), combining the synergistic benefits of PD-1/L1 inhibitors and anti-angiogenic agents. Ivonescimab is a cornerstone in Akeso's "IO 2.0" strategy, and Akeso has already initiated a series of Phase III and Phase II clinical trials investigating ivonescimab as a first-line treatment across multiple cancer indications. The initiation of a Phase III study of ivonescimab for LS-SCLC is another key step in extending Akeso's "IO 2.0" approach to earlier stages of lung cancer.