Hong Kong – November 06, 2026 -- Akeso's PD-1/VEGF bispecific antibody ivonescimab combined with chemotherapy produced a 70.1% major pathological response (MPR) rate and a 50.7% pathological complete response (pCR) rate in resectable non-small cell lung cancer (NSCLC), according to Phase II results published in Nature Medicine.
Chemotherapy combination delivers 70.1% MPR and 100% R0 resection
The trial tested perioperative ivonescimab as monotherapy or with chemotherapy. Patients received neoadjuvant treatment, then surgery, then adjuvant ivonescimab. Among patients who underwent surgery in the combination cohort, 68.7% had residual viable tumor of 5% or less.
The monotherapy cohort recorded an MPR rate of 60.0% and a pCR rate of 30.0%. Every patient who proceeded to surgery achieved R0 resection (100%). Twelve-month event-free survival exceeded 80% in both arms, which Akeso says compares favorably with outcomes in prior Phase III perioperative immunotherapy trials.
Squamous, Stage III and PD-L1-negative subgroups show strong activity
Patients with squamous histology reached an MPR rate of 81.5% and a pCR rate of 61.1%. Stage III patients reached an MPR rate of 65.5% and a pCR rate of 47.3%. PD-L1-negative patients posted a 69.2% MPR rate, comparable to PD-L1-positive patients.
Akeso identifies Stage IIIB disease, squamous histology and PD-L1-negative tumors as areas where current neoadjuvant immuno-chemotherapy regimens leave substantial unmet need.
No grade 3 or higher bleeding events reported
No grade 3 or higher bleeding events occurred, and no surgeries were cancelled because of treatment-related adverse events. Akeso describes the perioperative safety profile as manageable.
Recurrence rates of 30-70% define the clinical gap
About one-quarter of NSCLC patients have resectable disease at diagnosis. Between 30% and 70% of them experience recurrence after surgery, often with distant metastases.
Phase III program spans more than 17 studies
More than 17 Phase III studies of ivonescimab are underway globally. They include seven international multi-regional registrational trials and seven head-to-head studies against PD-1/PD-L1 therapies. Eight of the registrational or Phase III studies are in lung cancer. Others cover first-line MSS/pMMR colorectal cancer, head and neck squamous cell carcinoma, biliary tract cancer, triple-negative breast cancer, pancreatic cancer and urothelial carcinoma.
Akeso describes ivonescimab as the first therapy to show positive Phase III head-to-head results against pembrolizumab. Summit Therapeutics holds exclusive rights to develop and commercialize the drug in the United States, Canada, South America, Europe, the Middle East, Africa and Japan, under an agreement worth up to US$5 billion.