CStone Pharmaceuticals said on October 26, 2026, that CS2009 clinical data from more than 300 patients showed antitumor activity across several solid tumors. The company is preparing global Phase III registrational studies of the investigational antibody.
Key Takeaways
- CStone presented lung and colorectal cancer results at the ESMO 2026 congress.
- The company reported responses both to CS2009 alone and in combination with chemotherapy.
- CStone is preparing Phase III studies and discussing potential partnerships with multinational pharmaceutical companies.
CS2009 clinical data in lung cancer
CS2009 is designed to target the PD-1, VEGF and CTLA-4 pathways. CStone said its observations support activity across all three pathways and that severe CTLA-4-associated and VEGF-related toxicities occurred at low rates.
In previously untreated non-small-cell lung cancer with high PD-L1 expression, CS2009 alone produced an objective response rate of 87.5%. At the 30 mg/kg dose, the rate was 100%.
| Item | Details |
|---|---|
| Previously treated lung cancer, CS2009 alone | 28.0% response rate at 30 mg/kg; median response duration of 10.5 months |
| First-line squamous lung cancer, with chemotherapy | 85.7% response rate at 30 mg/kg |
| Second- or third-line lung cancer after immunotherapy, with chemotherapy | 55.6% response rate at 30 mg/kg |
| Heavily pretreated metastatic colorectal cancer, CS2009 alone | 20.0% response rate and 93.3% disease control rate |
Colorectal cancer results and development plans
In previously untreated metastatic colorectal cancer, CS2009 combined with XELOX chemotherapy produced an objective response rate of 63.6% and a disease control rate of 100%. Among patients with liver metastases, the response rate was 68.8%.
CStone said follow-up in the colorectal cancer group was limited. It also reported activity in other solid tumors and said it is actively discussing partnerships to advance CS2009 globally. The company did not provide a start date for the planned Phase III studies.
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