Phase II Perioperative Ivonescimab for NSCLC Shows Significant Results at WCLC 2024

HONG KONG, Sept. 8, 2024 – Akeso (9926.HK) has announced promising results from a Phase II study of its PD-1/VEGF bispecific antibody, ivonescimab, for the treatment of resectable non-small cell lung cancer (NSCLC). These findings were presented at the 25th World Conference on Lung Cancer (WCLC). This marks the third oral presentation of ivonescimab at an international conference in 2024, with Professor Zhao Xiaoliang from Tianjin Medical University Cancer Hospital delivering the presentation and showcasing advancements in cancer immunotherapies from China.

The AK112-205 study, as of February 2024, enrolled 60 patients, with 78.3% in stage III of NSCLC and 90% in the N+ stage. Among these, 49 patients underwent successful R0 resections. The study revealed significant pathological complete response (pCR) and major pathological response (MPR) rates when using ivonescimab, either alone or with chemotherapy, for perioperative treatment. Notably, the combination of ivonescimab and chemotherapy showed higher MPR and pCR rates across various tumor stages and PD-L1 expression subgroups compared to ivonescimab monotherapy.

In the ivonescimab and chemotherapy cohort, the pCR rate was reported at 43.6% and the MPR rate at 71.8%, with 69.2% of patients having residual viable tumors below 5%. By August 2024, 55 patients in this cohort had completed surgery, with improved pCR and MPR rates of 52.7% and 72.7%, respectively. For squamous NSCLC, the rates were notably higher, with pCR at 63.6% and MPR at 84.1%.

Ivonescimab monotherapy showed a pCR rate of 30.0% and an MPR rate of 60.0%. Though Event-Free Survival (EFS) data is still maturing, there is evidence suggesting a strong correlation between pCR and EFS. Importantly, the treatment's safety profile was manageable, with no treatment-related adverse events (TRAEs) causing surgery cancellations, delays, or complications in wound healing.

Ivonescimab, a unique PD-1/VEGF bi-specific immunotherapy, was developed by Akeso. It has been approved in China for treating EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI therapy. It is the first bispecific antibody in the world with a dual mechanism targeting cancer immunotherapy and anti-angiogenesis. Akeso has licensed rights to Summit Therapeutics for development and commercialization in several regions, including the United States, Canada, Europe, and Japan, among others.

A Phase III study comparing ivonescimab monotherapy to pembrolizumab monotherapy for first-line treatment of PD-L1+ NSCLC has met its primary endpoint of progression-free survival (PFS) in an interim analysis. This successful outcome has led to a supplemental New Drug Application (sNDA) for ivonescimab as first-line treatment for PD-L1+ NSCLC, which has been granted priority review. Additionally, Phase III studies are ongoing for ivonescimab combined with chemotherapy versus tislelizumab with chemotherapy for squamous NSCLC, as well as other international studies led by Summit.

Future clinical trials include new Phase III studies testing ivonescimab in combination with AK117 (CD47) for head and neck squamous cell carcinoma, ivonescimab regimens for cholangiocarcinoma, and pancreatic cancer. Overall, ivonescimab is involved in over 25 clinical trials across 17 indications, including lung, pancreatic, breast, hepatocellular carcinoma, and colorectal cancers.

Akeso, established in 2012, is a prominent biopharmaceutical company known for its innovative biological medicines. It has a comprehensive R&D innovation system and a GMP-compliant manufacturing setup. With a robust pipeline of over 50 innovative assets, Akeso focuses on developing first-in-class and best-in-class new drugs across various major diseases, aiming to provide affordable therapeutic antibodies globally and create significant commercial and social value.