CheckMate 816
CheckMate 816 was the first trial to show that immunotherapy before lung cancer surgery improves survival.
358 patients. pCR 24.0% vs 2.2%; EFS HR 0.63; OS HR 0.72 (5-year OS 65% vs 55%, 2025 update). First neoadjuvant-only IO approval (2022). Perioperative designs (KEYNOTE-671, CheckMate 77T, AEGEAN) followed.
- 24 vs 2.2 out of 100 had no cancer left at surgery with Nivolumab + chemotherapy compared with Chemotherapy; 21.8 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 31.6 vs 20.8 months with Nivolumab + chemotherapy compared with Chemotherapy; about 10.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.43 to 0.91).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 65 vs 55 out of 100 alive at 5 years with Nivolumab + chemotherapy compared with Chemotherapy; 10 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.52 to 0.99).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Resectable stage IB-IIIA NSCLC: neoadjuvant nivolumab + platinum chemotherapy (3 cycles) vs chemotherapy. People in a different situation may not see the same effect.
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.
358 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathologic complete responseprimary | Nivolumab + chemotherapy | 179 | 24% | — | <0.001 | link |
| Chemotherapy | 179 | 2.2% | ||||
| Event-free survivalprimary | Nivolumab + chemotherapy | — | 31.6 months | 0.63 (0.43–0.91) | 0.005 | link |
| Chemotherapy | — | 20.8 months | ||||
| Overall survival at 5 years | Nivolumab + chemotherapy | — | 65% | 0.72 (0.52–0.99) | — | link |
| Chemotherapy | — | 55% |
Pages like this
not linked directly; found by shared links- TrialNICHE-2
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Nivolumab.
- TermMajor pathological response (MPR)
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
- PersonChristian Blank
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Neoadjuvant / adjuvant / perioperative, Nivolumab.
- Key paperCheckMate 816: three cycles of nivolumab plus chemotherapy before lung cancer surgery
Shares Patrick M. Forde, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Nivolumab.
- TermWindow-of-opportunity trial
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
- TrialKEYNOTE-671
Shares Neoadjuvant / adjuvant / perioperative, Non-small-cell lung cancer.
- TrialNADINA
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Neoadjuvant / adjuvant / perioperative, Nivolumab.
- TrialMATTERHORN
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.