Akeso, Inc. announced positive Phase II data for ivonescimab in patients with resectable non-small cell lung cancer (NSCLC). The study measured pathological complete response (pCR) and major pathological response (MPR) as primary outcomes. Results show a 50.7% pCR rate and a 70.1% MPR rate when ivonescimab is combined with chemotherapy.
Phase II Study Shows Strong Response in Resectable NSCLC
The trial enrolled patients eligible for surgery and treated them before and after the operation. Researchers evaluated ivonescimab as a single agent and in combination with standard chemotherapy. The combination arm achieved the highest response rates, with more than two-thirds of patients reaching major pathological response. Safety data were consistent with known profiles for each component, and no new safety signals emerged.
Implications for the Growing Bispecific Antibody Market
Ivonescimab belongs to a class of bispecific antibodies that bind two targets at once. Its dual activity against PD-1 and VEGF pathways may offer an advantage over single-target agents. According to TrendX Insights’ Bispecific Antibody Market, the market is projected to reach USD 81.51 bn by 2034, reflecting a 28.6% compound annual growth rate. The strong Phase II results add concrete evidence that bispecific formats can succeed in early-stage disease settings.
Clinical Impact of Dual PD-1 and VEGF Blockade
Traditional treatment for resectable NSCLC relies on surgery followed by adjuvant chemotherapy or immunotherapy. Adding ivonescimab before surgery aims to shrink tumors and eradicate micrometastatic cells. The high pCR rate suggests that many tumors were cleared before resection, potentially allowing less extensive surgery. Early eradication of disease may also lower the risk of recurrence, though longer follow-up is needed to confirm survival benefits.
Future Development Plans and Competitive Landscape
Akeso plans to move the program into Phase III trials to validate these findings in a larger patient cohort. The company expects to file regulatory submissions after successful completion of pivotal studies. Several competitors are developing bispecific antibodies for lung cancer, but the current efficacy data give Akeso a clear advantage. Investors are watching upcoming oncology conference presentations for additional safety and efficacy details.
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