Back to news

Agenus Announces Nature Medicine Publication of Multicenter UNICORN Phase 2 Trial Demonstrating Deep Responses with Neoadjuvant BOT+BAL in Resectable Colon Cancer

Business Wire•02/11/2026•06:43 ET
1

Key Highlights

  • ➤pMMR/MSS BOT+BAL produced 36% major and 29% complete pathologic responses
  • ➤pMMR/MSS BOT+BAL achieved 71% overall pathologic response after three doses
  • ➤dMMR/MSI-H BOT+BAL delivered 100% major and 93% complete pathologic responses
  • ➤BOT+BAL cohorts had zero recurrences and 100% 12-month event-free survival
  • ➤Agenus plans Phase 3 ROBBIN trial in high-risk Stage II/III MSS/pMMR colon cancer

Expert Statements

Steven O’Day, Chief Medical Officer of Agenus

“UNICORN delivers compelling, independent evidence that BOT+BAL can produce deep responses in MSS colon cancer, a disease historically resistant to conventional immunotherapy”

Filippo Ghelardi, first author and Medical Oncology Fellow of Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

“UNICORN gave us a rare opportunity to look beyond whether a tumor responded and examine what was changing biologically during a very short period before surgery”

Filippo Ghelardi, first author and Medical Oncology Fellow of Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

“The alignment we observed between deep pathologic responses, clearance of circulating tumor DNA and changes within the tumor immune environment provides multiple signals of treatment activity.”

Filippo Pietrantonio, senior author, study principal investigator and Head of the Gastrointestinal Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

“For many years, MSS colon cancer has largely been considered resistant to immunotherapy. The UNICORN study challenges that assumption in the curative-intent setting”

Filippo Pietrantonio, senior author, study principal investigator and Head of the Gastrointestinal Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

“The purpose of moving treatment earlier is not simply to shrink the tumor before surgery. It is to prevent the disease from returning and ultimately increase the number of patients who may be cured.”

Agenus Announces Nature Medicine Publication of Multicenter UNICORN Phase 2 Trial Demonstrating Deep Responses with Neoadjuvant BOT+BAL in Resectable Colon Cancer

* In pMMR/MSS colon cancer, neoadjuvant BOT+BAL met the trial’s primary endpoint with a 36% major pathologic response rate, including 29% pathologic complete response, within an overall 71% pathologic response rate after one BOT dose and two BAL doses

Get started

Create a free account to read the full story.

Sign Up

Already have an account? Log in