At the high-profile European Lung Cancer Conference (ELCC) 2024, Akesobio and its partner Summit Therapeutics (Summit) jointly released the PD-1/VEGF dual antibody Ivonescimab(AK112/SMT112) combined with chemotherapy for the first-line treatment of advanced non-cancer lung cancer. Updated data from Cohort 1 (EGFR/ALK wild type) of the Phase II small cell lung cancer (NSCLC) clinical study (AK112-201). Previous research results have been published at the 2023 ASCO Annual Meeting and eClinical Medicine, a subsidiary of the top international medical journal "The Lancet".

Cohort 1 included a total of 135 patients with EGFR/ALK wild-type NSCLC who received Ivonescimab combined with chemotherapy, including 63 patients with squamous cell carcinoma and 72 patients with non-squamous cell carcinoma. As of October 2023, the median follow-up time has been further extended to 21.3 months. As the follow-up time is extended, the clinical advantages of Ivosib in the first-line treatment of advanced or metastatic NSCLC become more obvious.

The objective response rate (ORR) of Ivonescimab combined with chemotherapy in the first-line treatment of patients with non-squamous NSCLC reached 54.2%, the disease control rate (DCR) reached 95.8%, and the median duration of response (mDOR) reached 15.4 months. The median progression-free survival (mPFS) was 13.3 months, the 9-month PFS rate was 58.9% and the 9-month overall survival (mOS) rate was 81.9%.

The ORR of Ivonescimab combined with chemotherapy in the first-line treatment of squamous NSCLC patients reached 71.4%, DCR reached 90.5%, and mDOR reached 12.7 months; mPFS was 11.1 months, 9-month PFS rate was 65.1%, and 9-month OS The rate is 90.4%.

No intracranial hemorrhage was observed in treated patients with brain metastases.

Meanwhile the updated efficacy data of cohort 2 and cohort 3 were also disclosed accordingly and as the follow-up time is further extended, the efficacy and safety advantages of Ivosi are stable.

Cohort 2: EGFR-mutated advanced non-squamous NSCLC that progressed on EGFR-TKI

When the median follow-up time was 25.8 months, the ORR was 68.4%, the DCR was 94.7%, the mDoR was 8.7 months; the mPFS was 8.5 months, the mOS reached 22.5 months, and the 12-month OS rate was approximately 73.7%.

Cohort 3: Treatment of advanced NSCLC progressing on prior anti-PD-1 therapy combined with platinum doublet chemotherapy

When the median follow-up time was 24.7 months, the ORR was 40%, the DCR was 80%, the mDoR was 12.7 months; the mPFS was 7.1 months, the mOS reached 17.1 months, and the 12-month OS rate was 65%.

At present, Akesobio has successfully submitted a new drug application (NDA) for the indication of Ivosi for the treatment of NSCLC and is in the priority review stage. Globally, a total of 6 Phase III clinical studies ofIvonescimab are ongoing.

About Ivonescimab (PD-1/VEGF double antibody, AK112/SMT112)

Ivonescimab is the world's first new PD-1/VEGF bispecific antibody drug independently developed by Akesobio. It is designed based on the company's unique Tetrabody technology and can block the combination of PD-1 with PD-L1 and PD-L2, and Simultaneously blocks the binding of VEGF to VEGF receptors. The combination therapy of PD-1 antibodies and VEGF blockers has shown strong efficacy in various tumor types (non-small cell lung cancer, renal cell carcinoma and hepatocellular carcinoma). Given the co-expression of VEGF and PD-1 in the tumor microenvironment, AK112 as a single agent may block both pathways more effectively than combination therapy, thereby enhancing anti-tumor activity. .

In December 2022, Ivonescimab awarded the American Summit Therapeutics a cooperation plan with a total transaction volume of up to 5 billion U.S. dollars (a down payment of 500 million U.S. dollars), plus a double-digit commission on net sales, in the United States, Europe, Canada and Japan. Developed exclusive licensing rights and set a record for the highest transaction amount for a single innovative drug in China. Previously, three indications of Evosit in the field of lung cancer have been granted Breakthrough Therapy Designation by CDE. In August 2023, Evosi's first new drug marketing authorization application (NDA) was accepted and granted priority review status.

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