Agenus (AGEN) Reports 100% Major Pathologic Response in dMMR Combination Cohort
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In the 14-patient dMMR/MSI-H BOT+BAL cohort, all patients achieved a major pathologic response and 13 (93%) achieved a complete response. At the February 9, 2026 cutoff, no BOT+BAL patients had recurrence; 12-month event-free survival was 100% in both combination cohorts.
Material Details
| # | Detail | AI Analyst View |
|---|---|---|
| 1 | dMMR/MSI-H BOT+BAL: 14/14 achieved MPR | A 100% major response rate is a strong early clinical signal, but comes from a 14-patient, non-randomized cohort. |
| 2 | dMMR/MSI-H BOT+BAL: 13/14 achieved pCR | The 93% complete response rate adds depth to the signal; larger controlled trials are needed to establish benefit. |
| 3 | pMMR/MSS BOT+BAL: 36% achieved MPR | MSS disease is the key development opportunity; the reported rate exceeds the cited historical rates of approximately 20% for prior immunotherapy and 8% for chemotherapy. |
| 4 | pMMR/MSS BOT+BAL: 29% achieved pCR | Complete responses in this harder-to-treat cohort support further testing, but the sample included only 14 patients. |
| 5 | 12-month EFS was 100% in both combination cohorts | Follow-up was limited to median 19.2 months in pMMR/MSS and 16.7 months in dMMR/MSI-H; durability remains to be confirmed. |
| 6 | All 56 patients underwent surgery | Surgical feasibility supports the neoadjuvant approach; planned timing was preserved in 98% of patients. |
Context by AI Analyst
These are early Phase 2 findings from a 56-patient, non-randomized study, now peer reviewed alongside the independent NEST study. The next major catalyst is Agenus's planned randomized Phase 3 ROBBIN trial, which will compare neoadjuvant BOT+BAL followed by standard care with standard care alone in high-risk Stage II or Stage III MSS/pMMR colon cancer.
Based on the original press release from Agenus Inc. distributed by BusinessWire.
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