Akeso Completes Enrollment in Phase III Trial of PD-1/VEGF Bispecific Antibody (AK112) Combined with Chemotherapy in EGFR-TKI-resistant nsq-NSCLC

HONG KONG,Nov. 4,2022 --Akeso,Biopharma (9926. HK) ("Akeso") announced the patient enrollment completion for the Phase III clinical trial of Ivonescimab (PD-1/VEGF bi-specific antibody,AK112) combined with chemotherapy for the treatment of EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who have failed to epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment.

This trial is a randomized,double-blind,multi-center Phase III clinical trial,which started patient enrollment in end of January 2022,and it has enrolled 320 participants as of the date of this press release. The primary endpoint of the trial is progression-free survival (PFS) assessed by IRRC. This therapy was granted Breakthrough Therapy Designation by the Center for Drug Evaluation,National Medical Products Administration (CDE,NMPA) lately in October 2022.

Lung cancer is a malignant tumor with high incidence and high mortality rates worldwide. The incidences of lung cancer around the world and in China have exceeded 2.2 million and 810 thousand respectively in 2020. Non-small cell lung cancer (NSCLC) patients account for 85% of total lung cancer patients,and about 70% of NSCLC patients are diagnosed at advanced stages. In China,nsq-NSCLC accounts for 70% of NSCLC,and about 40%-50% of nsq-NSCLC patients have EGFR mutation.

Immunotherapy plus anti-angiogenesis therapy has proved its combination advantages in previous studies worldwide. Lung cancer is one of the mainstream exploration areas of this therapy. AK112 could simultaneously block PD-1 and VEGF targets and has demonstrated favourable safety profile and promising anti-tumor efficacy in ongoing studies conducted by Akeso. AK112 in combination with chemotherapy is expected to provide a novel and effective therapy for the treatment of EGFR-mutated locally advanced or metastatic nsqNSCLC patients who have failed to EGFR-TKI treatment.

ABOUT IVONESCIMAB (PD-1/VEGF BI-SPECIFIC ANTIBODY,AK112)

Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso. Engineered with our unique Tetrabody technology,Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2,and blocks VEGF binding to VEGF receptors. PD-1 antibody combined with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma,non-small cell lung cancer and hepatocellular carcinoma). In view of the co-expression of VEGF and PD-1 in the tumor microenvironment,Ivonescimab,as a single agent to block these two targets,may block these two pathways more effectively and enhance the antitumor activity,as compared to combination therapy.

Currently,Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition,a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has been investigated in multiple clinical trials for various stages treatment of indications including non-small cell lung cancer and small cell lung cancer.

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