Agenus reports 36% major pathologic response in Phase 2 UNICORN colon cancer trial
Agenus announced that its Phase 2 UNICORN trial of neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable colon cancer met its primary endpoint, with 36% of pMMR/MSS patients achieving a major pathologic response and 29% a complete response. No patient in the combination arms experienced cancer recurrence, and 12‑month event‑free survival was 100% across both pMMR/MSS and dMMR/MSI‑H cohorts. The company said the data support moving forward with the planned global Phase 3 ROBBIN trial in high‑risk MSS/pMMR colon cancer.
Why it matters
The company expects the trial results to strengthen the rationale for its upcoming Phase 3 ROBBIN study, which could eventually lead to a new approved therapy for MSS colon cancer and generate future revenue (the company’s press release states this).
Key facts
- 1The UNICORN trial enrolled 56 patients across four non‑randomized cohorts of 14 each. simcoereformer.ca
- 2In the pMMR/MSS cohort treated with BOT+BAL, 36% achieved a major pathologic response (≤10% viable tumor). simcoereformer.ca
- 3In the same cohort, 29% achieved a pathologic complete response (no viable tumor). simcoereformer.ca
- 4Overall, 71% of pMMR/MSS patients had at least a 50% tumor reduction. simcoereformer.ca
- 5Median follow‑up was 19.2 months in pMMR/MSS disease and 16.7 months in dMMR/MSI‑H disease. simcoereformer.ca
- 6Twelve‑month event‑free survival was 100% in both combination cohorts. simcoereformer.ca
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.