Akeso Biopharma shared on LinkedIn:
“Results from a Phase II clinical study evaluating ivonescimab in the perioperative treatment of resectable non-small cell lung cancer have been published in the journal Nature Medicine.
Among patients who underwent surgery, the major pathological response (MPR) rate was 70.1% and the pathological complete response (pCR) rate was 50.7%.”
About Phase II Study of Ivonescimab in Resectable Non-Small Cell Lung Cancer
A Phase II clinical study evaluating ivonescimab in the perioperative treatment of resectable non-small cell lung cancer (NSCLC) has reported encouraging pathological response rates, with findings published in Nature Medicine.
Among patients who underwent surgery, the study reported a major pathological response (MPR) rate of 70.1% and a pathological complete response (pCR) rate of 50.7%.
Major pathological response refers to the presence of 10% or less viable tumor cells in the resected primary tumor following preoperative treatment, while pathological complete response indicates the absence of residual viable cancer in the assessed surgical specimens.
Ivonescimab, developed by Akeso Biopharma, is a bispecific antibody designed to target both PD-1 and VEGF, combining immune checkpoint inhibition with anti-angiogenic activity.
The findings contribute to growing research into the potential role of bispecific antibodies in earlier stages of lung cancer, where perioperative treatment strategies aim to improve outcomes for patients undergoing surgery.
Key Findings:
- In the ivonescimab plus chemotherapy cohort, the MPR rate reached 70.1%, the pCR rate was 50.7%, and 68.7% of patients had residual viable tumor (RVT) ≤5%.
- The ivonescimab monotherapy cohort also showed meaningful pathological responses, with an MPR rate of 60.0% and a pCR rate of 30.0%.
- Both cohorts achieved high objective response rates and frequent T-stage downstaging. All patients who proceeded to surgery achieved R0 resection (100%). The 12-month event-free survival (EFS) rates exceeded 80% in both arms, comparing favorably with outcomes reported in prior Phase III perioperative immunotherapy trials.
- Subgroup analyses revealed particularly notable activity in clinically relevant populations: patients with squamous histology achieved an MPR rate of 81.5% and a pCR rate of 61.1%; those with Stage III disease achieved an MPR rate of 65.5% and a pCR rate of 47.3%; and PD-L1-negative patients achieved an MPR rate of 69.2%, comparable to that observed in PD-L1-positive patients.
- The perioperative safety profile of ivonescimab was manageable. No grade ≥3 bleeding events occurred, and no surgeries were cancelled due to treatment-related adverse events.
You can read more about the Akeso Biopharma and Phase II ivonescimab study and its findings on OncoDaily.