Promising Data for Investigational Innovative Bispecific Ivonescimab Featured at ASCO 2023 - Seite 2

The poster also contains brief updates related to the two other cohorts in this trial:

• Cohort 2: Advanced or metastatic non-squamous EGFR-mutated NSCLC patients whose tumor has progressed following treatment with an EGFR-TKI
• Cohort 3: Advanced or metastatic NSCLC patients whose tumor has progressed following PD-(L)1 therapy combined with doublet-platinum chemotherapy.

Of the 19 patients in Cohort 2, median PFS of 8.5 months was experienced; median overall survival was not reached. The ORR for patients in this cohort was 68% and the median duration of response (DOR) was 8.5 months. Approximately 32% of patients in this cohort remained on treatment at 12 months.

There were 20 patients in Cohort 3; these patients experienced a median PFS of 7.1 months and median OS was 15.6 months. The ORR for patients in this cohort was 40% and the median DOR was 12.4 months. Approximately 35% of patients in this cohort remained on treatment at 12 months.

Ivonescimab had an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with advanced or metastatic NSCLC who had progressed following an EGFR-TKI, as well as in combination with chemotherapy for patients who had progressed following treatment with a PD-(L)1 inhibitor plus platinum-doublet chemotherapy in this clinical study.

In May 2023, the first patient was treated in Summit’s license territories in the Phase III HARMONi clinical trial. HARMONi intends to evaluate ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (AK112-301, NCT05184712).

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.² This tetravalent structure, the intentional design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which is intended to improve side effects and safety concerns associated with these targets and has the potential to focus the antitumor activity of both targets. Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.