Loading
In NICHE-2, four weeks of immunotherapy before surgery wiped out most mismatch-repair-deficient colon cancers, and nobody had relapsed three years later.
Pathologic response in 98%, major pathologic response 95%, pathologic complete response 68% (NEJM 2024). Three-year disease-free survival 100% (ESMO 2024). No patient needed chemotherapy. NICHE-3 (nivolumab + relatlimab) and the ATOMIC adjuvant trial extend the evidence; organ-preservation trials in rectal cancer (AZUR-1) follow the same logic.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
115 registered.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathologic complete responseprimary | Neoadjuvant nivolumab + ipilimumab | 111 | 68 percent | - | - | link |
| 3-year disease-free survival | Neoadjuvant nivolumab + ipilimumab | 111 | 100 percent | - | - | link |
For colon cancer that is mismatch-repair deficient (about 10-15% of colon cancers, more in older patients), a single short course of immunotherapy before surgery is now a reasonable standard and is far more effective than chemotherapy, which has little effect in this subtype. It requires testing every colon cancer for mismatch repair at diagnosis, before surgery. Whether some patients can safely skip surgery, as in dMMR rectal cancer, is the next question.
This is the paper Europe PMC returns for registry id NCT03026140 with the most citations, so it is the natural first reading for anyone following the NICHE-2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
This small trial explained why colorectal cancer had seemed immune-resistant (most is MMR-proficient) and established the principle that a genomic feature, not the tissue of origin, can predict immunotherapy response. It led directly to the 2017 tissue-agnostic approval of pembrolizumab and to routine MMR/MSI testing of many cancers. Every patient with advanced dMMR cancer should now be considered for checkpoint blockade.
It is the evidence behind universal mismatch repair testing of every colorectal cancer, which is now standard in most guidelines and which, as a by-product, identifies everyone eligible for immunotherapy.
Shares Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Mismatch-repair deficient (MSI-high) colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
Shares Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work, Mismatch-repair deficient (MSI-high) colorectal cancer.
Shares Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer, Le 2015: PD-1 blockade works in tumours with mismatch-repair deficiency, whatever the organ, Cold tumours and the immunosuppressive microenvironment, Mismatch-repair deficient (MSI-high) colorectal cancer.
Shares Myriam Chalabi, NICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients, Mismatch-repair deficient (MSI-high) colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
Shares NICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients, Le 2015: PD-1 blockade works in tumours with mismatch-repair deficiency, whatever the organ, Pathologic complete response (pCR), Mismatch-repair deficient (MSI-high) colorectal cancer.
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Netherlands Cancer Institute (NKI-AvL), Neoadjuvant / adjuvant / perioperative, Ipilimumab.
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Netherlands Cancer Institute (NKI-AvL), Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work, Neoadjuvant / adjuvant / perioperative.
Shares NICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Neoadjuvant / adjuvant / perioperative, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation.