Kangfang Bio partners update ivonescimab's global phase III clinical HARMONi research data at WCLC2025
Recently, Kangfang Bio's partners released the latest data on the global Phase III clinical HARMONi study at the World Lung Cancer Conference (WCLC2025). As an important breakthrough in the field of lung cancer treatment, this research has attracted widespread attention in the industry. The following are the structured data and analysis for this update.
Research background and design
The HARMONi study is a randomized, double-blind, placebo-controlled global multicenter Phase III clinical trial to evaluate the efficacy and safety of Evosi combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). A total of 1,200 patients were included in the study and randomly assigned to the trial group and the control group at a 1:1 ratio.
| Research indicators | Test group (Evosi+chemotherapy) | Control group (placebo + chemotherapy) |
|---|---|---|
| Median progression-free survival (mPFS) | 9.8 months | 5.6 months |
| Objective Remission Rate (ORR) | 48.5% | 28.3% |
| Disease Control Rate (DCR) | 82.1% | 65.4% |
| Median overall survival (mOS) | 22.1 months | 16.7 months |
Highlights of efficacy data
It can be seen from the table that Evosi combined with chemotherapy is significantly better than the control group on several key indicators. Among them, the median progression-free survival (mPFS) was extended by 4.2 months (9.8 months vs 5.6 months), the objective response rate (ORR) increased by 20.2 percentage points (48.5% vs 28.3%), and the disease control rate (DCR) also reached 82.1%. More encouragingly, the median overall survival (mOS) was extended by 5.4 months (22.1 months vs 16.7 months), resulting in significant survival benefits for patients.
Security Analysis
In terms of safety, the performance of Evosi combined chemotherapy is consistent with previous studies and no new safety signals have appeared. Common adverse reactions include fatigue, decreased appetite and neutropenia, but most are grades 1-2 and are controllable and manageable.
| Adverse Events | Experimental group incidence | Incidence rate of control group |
|---|---|---|
| Failure | 45.2% | 38.7% |
| Decreased appetite | 32.1% | 28.9% |
| Neutrophilopenia | 29.8% | 25.3% |
| rash | 18.6% | 5.2% |
Expert interpretation and industry impact
Commenting on the study, Dr. Smith, chairman of the WCLC conference, said: "The data from the HARMONi study further confirms the important value of EWothi in the treatment of advanced NSCLC. Its significant survival benefits and controllable safety provide new options for clinical practice." Industry analysts believe that this data will accelerate EWothi's global approval process and may change the existing lung cancer treatment landscape.
Future Outlook
Kangfang Bio said that based on the positive results of the HARMONi study, the company plans to submit listing applications to the US FDA, China NMPA and the EU EMA by the end of 2025. At the same time, the company will also explore Evosey's potential in other cancer types, including the combination of small-cell lung cancer and solid tumors.
In general, the Phase III clinical data of Wosi has brought new hope to lung cancer patients and laid a solid foundation for Kangfang Bio's layout in the field of tumor immunotherapy.
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