OnCo
trialsTrialPositive

NADINA

Giving the immunotherapy doublet before surgery, instead of nivolumab after, cut the risk of recurrence by about two thirds and let most patients skip further treatment.

Presented at the ASCO 2024 plenary and published in NEJM (June 2024). 12-month EFS 83.7% vs 57.2%; HR for progression, recurrence or death 0.32. Around 59% of the neoadjuvant arm had a major pathological response and received no adjuvant therapy. The first phase 3 in oncology to test an immunotherapy-only neoadjuvant regimen against standard of care; adopted into NCCN and ESMO guidance as a preferred option for resectable nodal disease.

Setting
Resectable macroscopic stage III melanoma: two cycles neoadjuvant ipilimumab + nivolumab then surgery (adjuvant only if incomplete response) vs surgery then 12 cycles adjuvant nivolumab
Phase
Phase 3
Sponsor
Netherlands Cancer Institute / Melanoma Institute Australia
Registry
Headline result
12-month EFS 83.7% vs 57.2%; HR 0.32.
Reported
2024
Enrolled
423
Replication
SWOG S1801 (neoadjuvant pembrolizumab) independently showed an EFS benefit for the neoadjuvant sequence, with a different drug.

Outcomes

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In plain words
What these results mean for people, not percentages
423 people took part
Event-free survival at 12 monthsprimarysurrogate endpoint
  • 83.7 vs 57.2 out of 100 free of a major event at 12 months with Neoadjuvant ipilimumab + nivolumab compared with Adjuvant nivolumab; 26.5 more per 100.
  • Roughly one extra person helped for every 4 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 68 percent lower chance of the event at any given time (hazard ratio 0.32).
  • 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.
  • These results apply to the people the trial enrolled: Resectable macroscopic stage III melanoma: two cycles neoadjuvant ipilimumab + nivolumab then surgery (adjuvant only if incomplete response) vs surgery then 12 cycles adjuvant nivolumab. 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.

423 participants enrolled.

Event-free survival at 12 monthsprimary
HR 0.32
Neoadjuvant ipilimumab + nivolumab83.7 of 100
Adjuvant nivolumab57.2 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Event-free survival at 12 monthsprimaryNeoadjuvant ipilimumab + nivolumab83.7%0.32link
Adjuvant nivolumab57.2%
Replication
SWOG S1801 (neoadjuvant pembrolizumab) independently showed an EFS benefit for the neoadjuvant sequence, with a different drug.

Connected

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