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January 31, 2022

Akeso secures China approval to start Phase II first-line breast cancer trial

Akeso also dosed the first subject in a Phase III ivonescimab trial in non-small cell lung cancer.

Akeso has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration to commence a Phase II clinical trial of monoclonal antibody ligufalimab (AK117) and bispecific antibody ivonescimab (AK112) for first-line breast cancer.

In the multicentre trial, the antibodies will be analysed in combination with chemotherapy as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).

A cluster of differentiation 47 (CD47) monoclonal antibody, ligufalimab is an immuno-oncology therapy developed by Akeso. 

Ivonescimab is a programmed cell death protein 1/ vascular endothelial growth factor (PD1/VEGF) bispecific antibody.

The trial will enrol subjects who have not received systemic antitumour treatment, and who are not fit for radical surgical resection or local treatment.

Individuals with locally advanced or metastatic TNBC whose ailment advances following surgical resection or local therapy will also be part of the trial.

The combination treatment of ivonescimab and ligufalimab is estimated to stimulate innate as well as adaptive immune pathways and boost the immune system to detect tumours.

Furthermore, the antibodies could potentially induce a synergy effect of immunity, antiangiogenesis and chemotherapy. 

Akeso anticipates attaining improved antitumour outcomes in advanced TNBC patients.

Lung cancer trial underway

Separately, the company has dosed the first subject in a Phase III trial of ivonescimab plus chemotherapy to treat locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutation failed following EGFR-TKI therapy.

The double-blind, randomised, multicentre trial will enrol nearly 320 participants in China. 

It will analyse the safety and efficacy of ivonescimab along with pemetrexed plus carboplatin, versus placebo plus pemetrexed and carboplatin, in advanced nonsquamous NSCLC patients with resistance to EGFR-TKI.

Progression-free survival as evaluated by IRRC is the primary goal of the trial.

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