Top KOLs Discussing NADINA
NADINA Trial Design
NADINA asked whether giving checkpoint inhibitors before surgery, while the nodal tumor is still in place, works better than the standard of surgery followed by a year of adjuvant nivolumab, and whether patients who respond well can skip adjuvant treatment. It was the first phase 3 trial of neoadjuvant checkpoint inhibition in melanoma, built on the earlier OpACIN, OpACIN-neo and PRADO studies. The trial is sponsored by the Netherlands Cancer Institute with Bristol Myers Squibb as collaborator and funder, and is additionally supported in Australia by an NHMRC grant. Christian U. Blank presented the primary analysis at the ASCO 2024 Plenary Session (LBA2) with simultaneous publication in the New England Journal of Medicine.
Study Design
Randomized 1:1, open-label, investigator-initiated phase 3 (NCT04949113); 423 randomized (212 neoadjuvant, 211 adjuvant). Stratified by BRAF status, continent and in-transit metastases.
Population
Resectable macroscopic stage III melanoma, de novo or recurrent, with at least one pathologically proven lymph node metastasis; up to 3 in-transit metastases allowed; no prior anti-PD-1, anti-CTLA-4, anti-LAG-3 or BRAF/MEK inhibitor therapy.
Neoadjuvant arm
Ipilimumab 80 mg plus nivolumab 240 mg every 3 weeks for 2 cycles, then therapeutic lymph node dissection. Major pathologic response (≤10% viable tumor): no further treatment. Otherwise 11 cycles of nivolumab 480 mg every 4 weeks (BRAF wild-type) or 46 weeks of dabrafenib plus trametinib (BRAF V600E/K).
Control arm
Therapeutic lymph node dissection followed by 12 cycles of adjuvant nivolumab 480 mg every 4 weeks, starting no later than week 12. Adjuvant radiotherapy allowed in both arms by physician decision.
Endpoints
Primary: event-free survival. Secondary: recurrence-free survival, distant metastasis-free survival, overall survival, pathologic response, immune-related adverse events, surgical morbidity, health-related quality of life and cost-effectiveness.
Data cuts & presenters
Primary analysis: cutoff Jan 12, 2024, median follow-up 9.9 months (Christian U. Blank, ASCO 2024). ESMO 2024 LBA42 and ESMO 2025 LBA57 (cutoff Apr 14, 2025): Minke W. Lucas. ESMO 2026 2076RO (cutoff Mar 30, 2026; 36 months): Sonja J. Witteveen.
NADINA at ESMO 2026: the 3-year update and the INTerpath-001 debate
Does this data support adjuvant ICI in near pCR, where EFS is even lower than pPR? Looking forward for more data in this subgroup #NADINA #ESMO26 https://t.co/eZUyWCaNXV
My personal take on the (again) NADINA up date: we cannot omit adjuvant therapy in near pCR; only in pCR #melanoma #ESMO2026 @GrupoMelanoma . Before making decisions from asumptions from small trials, we should think about how we translate them into confirmatory trials. https://t.co/uRaVb4NV1g
🔥🎯 #ESMO26 NADINA, 3y update Neoadjuvant ipi-nivo vs surgery + adjuvant nivo in macroscopic stage III #melanoma ➡️ 3y EFS 72.9% vs 50.0% | HR 0.42 ➡️ 3y DMFS 75.3% vs 57.4% | HR 0.46 ➡️ 3y RFS: pCR 91% | near-pCR 62% | pPR 88% | pNR 43% ➡️ G≥3 TRAEs 32% vs 16% 🔍 Read it next to the INTerpath-001 hype: in macroscopic stage III, adjuvant PD-1 alone is no longer the bar. ‼️: ~9% relapse after pCR, and near-pCR (no adjuvant) does worse than pPR (adjuvant given). Room for IO in 1-10% RVT? 🧬 RVT carries its own immune biology. @myESMO @OncoAlert @_SEOM @brunolarvol #Melanoma
Impressive results from INTerpath-001 #ESMO26 showing personalized mRNA vaccine works. Extraordinary tech but 17% did not have enough tissue for development. No increase in immune-tox and G5 were prior to mRNA. Not sure how this fits with NADINA & S1801. Cost will be a barrier. https://t.co/qJvgG5C0Q6
thanks for your reply. Actually, neoadjuvant pembro is not necessarily the standard for resectable Stage III; based on the NADINA study and on clinical judgement, ipi/nivo combo neoadjuvant therapy is often used instead of single agent pembro. It is paradoxical but true; the more approved or "proven" (but not FDA approved) therapies there are, the harder it is to design the next study. What is the "standard" treatment you compare to? Will all experts/investigators be able to agreed to such a standard? Will the comparison remain meaningful through trial data completion? There are also other historical comparison trials of single agent adjuvant immunotherapy for #melanoma, whose patient cohorts and endpoints may be more comparable. Again, it all comes down to full data disclosure tomorrow (and the inevitable simultaneous @NEJM or other publication).
Sad that the @myESMO embargo was broken... It is difficult to compare results between an adjuvant study and a neoadjuvant study (ie, S1801) in any cancer, including #melanoma. The patient populations were different and the primary endpoint (RFS vs EFS) was of necessity different for technical reasons that as @adamfeuerstein points out don't translate well to this platform. Until tomorrow's presentation we won't have all the data necessary to even try and compare. It is also important to note that NO drugs are technically @FDA approved for neoadjuvant treatment for melanoma. It's a moot point as several studies including S1801 and NADINA have made neoadjuvant therapy standard of care in some situations. I think it's great that the study (that I participated in) appears to have hit its primary endpoint, which typically ultimately translates into FDA approval. Tomorrow (1030 ET) will be interesting...
@MarioBalsaMD @myESMO Agree, need NADINA style comparative/control, especially with opportunity for path response adaptation. But great proof of concept and AEs aren’t too concerning.
When INTerpath-001 opened, neoadjuvant pembro had only one randomized phase 2 behind it. The phase 3 evidence came later with NADINA. Adjuvant pembro was a justified control arm. Evidence often moves faster than trials, that's everyday oncology. But I insist, it only applies to macroscopic disease, not to IIB-IIC or cN0 stage III.
Some thoughts on the INTerpath-001 backlash, and the simplistic "neoadjuvant already does better, so why bother" take. I think it misses a few important things. ➡️ First, the neoadjuvant data (S1801, NADINA) come from patients with macroscopic, clinically detectable nodal disease. INTerpath-001 also includes node-negative IIB/IIC and patients whose nodal disease only showed up on sentinel node biopsy. In the big SLN trials, about two thirds of SLN+ patients had deposits ≤1 mm. None of these patients are neoadjuvant candidates. We see the same confusion in #NSCLC all the time, when people compare stage IIIA from adjuvant trials (pathological staging) with stage IIIA from neoadjuvant trials (clinical staging). Same stage on paper, not the same patients. ➡️ Second, INTerpath-001 was designed before NADINA read out, when adjuvant anti-PD-1 was still the default for resected stage III. Judging it against today's practice is a bit of hindsight. ➡️ Third, I suspect the most logical place for a neoantigen vaccine is after neoadjuvant ICI in patients who don't reach pCR. INTerpath-009 is already testing exactly this in NSCLC, so we'll get some hints there. ➡️ And all of this comes with only an absolute ~3% increase in grade ≥3 toxicity, which also belongs in the balance. For macroscopic stage III, the critique lands. I want to see the full data and the stage breakdown at LBA1. But I'd be careful firing at this result before we've even seen it properly. @OncoAlert @Larvol @KolPulseAI @_SEOM @myESMO #Melanoma #ESMO26
@jasonwilliamsmd Promising, but: stage distribution, disease burden and absolute benefit. In NADINA 59% achieved a major pathological response after neoadjuvant ipi/nivo and omitted adjuvant therapy. Where does the vaccine add value within this evolving treatment landscape?
@adamfeuerstein Fair point on the control arm: for macroscopic stage III, neoadjuvant IO is now the bar (NADINA/S1801). But resected IIB/C and microscopic stage III have no neoadjuvant option — that's where INTerpath-001 matters. OS and subgroups will decide. #ESMO26
@FordePatrick NADINA HR 0.4 SWOG 1801 HR.58 - few doses of neoadj IO while primary is intact appears to be way better than jumping through the hoops to make individualized neoantigen vaccines on top of adj IO.
6️⃣ NEW SOC: neoadjuvant 👉 NADINA: nivo + ipi x2 ➡️ surgery ➡️ response-adapted adjuvant (none if MPR). 👉 24-mo EFS 77.3% vs 55.7% (HR 0.32); ~60% skip adjuvant. 👉 SWOG S1801: neoadj pembro x3 ➡️ 3-yr EFS 71% vs 49% (HR 0.51). 👉 Only for macroscopic (palpable) stage III. https://t.co/BTyOKa8pXr
Context: 77.3% vs 55.7% are the 24-month EFS rates from the ESMO 2025 update (HR 0.40); HR 0.32 is from the 2024 primary analysis (NEJM).
Physician reactions at ASCO 2024, ESMO 2024 and ESMO 2025
ESMO 2025 · 2-year update and first biomarker analyses (LBA57) · 3 posts
6. #NADINA: Ph III, NeoAdj Ipi/Nivo vs. Adj Nivo in Stg III melanoma. - NeoAdj Ipi/Nivo with improved EFS (HR: 0.40) and MFS (HR: 0.43) - Gr ≥ 3 AEs in ~31% vs. 16% 8/10 https://t.co/UiAOuwAb31 https://t.co/Ks1WDqQycm
My💎 #ESMO25 #Melanoma – Phase III NADINA keeps setting the bar: neoadj. nivo + ipi outperforms adjuvant therapy in resectable stage III melanoma 🎯 Median FU 25 mo: superior EFS & DMFS with neoadjuvant approach 💥 pCR → 95% RFS, 98% DMFS The immune orchestra plays better before surgery 🎶 And I must confess…I’ve always been in love with melanoma! And with NADINA too! 🧡 @OncoAlert #OncoAlertAF @OncoReporte @myESMO @_SEOM @MelanomaReAlli
#ESMO25 NADINA In resectable stage III melanoma, neoadjuvant nivo + ipi 2y EFS (77% vs 56%, HR 0.40) & DMFS (83% vs 64%, HR 0.43) vs adjuvant nivo. IFNγ, PD-L1 & TMB emerged as key predictors; IFNγ-high, TMB-high reached ~100% EFS. @OncoAlert @myESMO #ESMO25 https://t.co/SItP9QOqJN
ESMO 2024 · distant metastasis-free survival (LBA42), and later 2024 · 5 posts
@mhadfield30 @BrownMedicine @BrownUCancer @BrownUniversity Dr. Hadfield discussed NADINA trial of neoadjuvant Nivo plus ipi vs adjuvant Nivo in resectable stage 3 melanoma. Neoadjuvant immunotherapy in resectable melanoma looks great without neoadjuvant chemo. @mhadfield30 https://t.co/Se4OdRPlRf
Standing room only at #melanoma oral session @myESMO. Unprecedented survival in the pooled analysis of >800 patients, esp. patients who received combination neoadjuvant #immunotherapy. Updated results from #NADINA study - intern’l collaboration of @NKI_nl & @MelanomaAus showing continued significant improvement in event-free survival & also preventing distant metastases. #ESMO24
NADINA update from @MinkeLucas: DMFS data🚨 18 mo DMFS 85.7 vs 62.4%. Patterns of distant recurrence shown. MPR 60.8%. pCR 98.2% 18 month DMFS. The DMFS data are a key addition to the field. Ongoing clear superiority of neoadjuvant ipi1/nivo3 over adjuvant PD-1. Further evidence that NADINA is a new standard of care. #ESMO24 @OncoAlert
Proud to have contributed as US site NADINA @angelesclinic @MarkFariesMD we continue to accrue to clinical trials that inform optimal outcomes https://t.co/nNLNJISCIE
@OncBrothers @DrBetofMDPhD @CancerNetwrk @TarekHaykal1 @alantanmd @dr_yakupergun @HemOncWomenDocs @RenoHemonc @DrYukselUrun @HemOncFellows The neoadjuvant -Nadina data is great 2 doses of Ipi=Nivo and close to 60 % major path response & no further treatment Now have to convience surgeons to send them to us prior to surgery
ASCO 2024 Plenary (LBA2) and NEJM publication, June 2024 · 38 posts
Evidence supporting neoadjuvant IO is getting impossible to rebate, 🫁 and NADINA made it clear. Insisting on adjuvant IO after neo ❔Is needed for pCR pts? ❔Is really the best option for non-pCR pts? pCR is the best we have to test the tumor landscape in vivo! @NEJM #ASCO24 https://t.co/CXYZ1tBtBg
The Nadina Trial #ASCO24 2 ciclos de Ipi+Nivo como terapia neoadyuvante antes de cirugía vs cirugía seguido de 12 ciclos de Nivolumab. Solo aquellos que tuvieron respuesta parcial o no respondieron a terapia neoadyuvante recibieron terapia adyuvante con Nivolumab (11 ciclos) o … https://t.co/e7MyVkxFgT
the potential issue is that you can have censoring for many different reasons, which may be informative if not equal between arms. The authors of NADINA conducted a "Reverse Kaplan-Meier plot for EFS.". They conclude that "The timing and proportion of censoring was comparable between treatment groups." However, such analysis do not account for different reasons between groups with such high level of censoring, with different strategies and products, I'm worried about informative censoring. we described how you can have informative censoring with equal rates of censoring with @VPrasadMDMPH here: https://t.co/R6zsw6aXT2
🙌🙌 immediately practice-changing NADINA study - only 2 doses of neoadj ipi nivo (6 weeks) for macroscopic stage III melanoma rather than a year of adjuvant nivo 🤩improved EFS 🤩high major path response 59% 🤩response adapted adjuvant Rx #ASCO24 https://t.co/6goYoY8GQA https://t.co/vaiXfjnQJj
NADINA trial #ASCO24 #ASCO2024 ➡️massive early censoring in both arms (33% and 27% of patients at first time-point) We previously raised concerns with censoring in SWOG1801: https://t.co/996GI5nE0W Stay tuned for an in-depth analysis of censoring in NADINA @vkprasadlab
@NEJM Such an impressive benefit. HR of 0.32 when compared to a standard of care that was only a few years ago considered a huge leap forward for the field. What an incredible decade of progress. Has been a great thrill to have been a part of it!
One of the best educational sessions on advanced melanoma! #ASCO24 ✅ promising results from the #NADINA trial adding to the armamentarium of neo-adjuvant treatment options ! Exciting time for immunotherapy drug development. Day 4 now ! @HemOncFellows @OSUCCC_James https://t.co/XJVomyA168
Impressed by NADINA #ASCO24? Check out HRQL outcomes @ 36wks (Lucas et al @NKI_nl @MelanomaAus) 👍81% completion via @elektakaiku 😀Similar PF/EF/RF/pain- affected mainly by surgery, but given MPR 59% = many will avoid TLNDx Nil irAE PROs presented- watch this space! https://t.co/CwetjYUOjI
An amazing day at #ASCO24 learning about harmonized pan cancer neoadjuvant immune response evaluation #pathdata #INMC coupled with practice changing #NADINA results. Followed by this gem by @Bruceliupiano @chicagosymphony 6(!) encores. https://t.co/nm4QoaEeOh
Amazing study! Here are a few thought-provoking questions: 1⃣ What if safety and efficacy of dual-agent ICI were determined by the first few cycles in unresectable or metastatic melanoma? 2⃣ Or non-melanoma disease sites? 3⃣ Are there any studies exploring shorter ICI... 1/2
durations with rapid re-initiation upon progression? 4⃣ How did we decide on "until PD or toxicity" or 1-2y for many other diseases/settings? There may not be many incentives to ask these questions, but kudos to the #NADINA study investigators for this fascinating work! #ASCO24
Landmark results from the #NADINA trial, presented at #ASCO24! A study that is paving the way for response adapted treatment of melanoma. #Neoadjuvant #Immunotherapy #ASCO24 @ASCO @OncoAlert https://t.co/nXfPgitOpZ
@SuyogCancer @ASCO @Larvol @brunolarvol We need more therapy sequencing trials like this; very practical and welcome data! #asco24
So happy to be present to see this historic moment @ASCO #ASCO24 #melanoma #melsm 📈 🏅 Congratulations @ProfCUBlankNKI and the entire #NADINA team❗️ https://t.co/3Mr81QZ3SQ
Tfw #irAE has made it to the plenary as a stand alone slide As we move immunotherapy - and now combination therapy - earlier and earlier, more patients are at risk for #irAE Here a 7% risk of adrenal insufficiency with 2 doses of new SOC neoadjuvant ipi/nivo #NADINA #ASCO24 https://t.co/IoYtkZRz9q
Outstanding contribution to melanoma pts spearheaded by @ProfCUBlankNKI @ProfGLongMIA. Brilliant presentation and discussion at #ASCO24 plenary session! NADINA phase 3 trial showed compelling EFS advantage of neoadj ipi/nivo vs. adjuvant nivo (HR: 0.32), further supporting neoadjuvant checkpoint inhibition for stage III melanoma pts. Impact on outcomes and financial toxicity will be immense. Huge congratulations to everyone involved.
#ASCO24 Plenary Abstract 2️⃣ Dr Christian Blank #NADINA Neoadjuvant IpiNivo vs Adj Nivolumab in Stage 3 Melanoma ➡️ Impressive survival advantage for Neodj Ipi/Nivo 1yr EFS 83% vs 57%( HR 0.32, p<.001) #melanoma @OncoAlert https://t.co/RmxkmAfYnu
#ASCO24 Plenary🔥 Ph III NADINA trial, 2 x neoadj nivo+ipi + adj nivo v upfront surgery & adj nivo: - EFS benefit HR 0.32 (p<0.001) - RFS benefit tracks with MPR - OS awaited Phenomenal new SOc, from an investigator-initiated trial! @ASCO @myesmo @oncoalert @ProfCUBlankNKI https://t.co/gRDhqVSCia
Neoadjuvant nivo plus ipi versus adj nivo in macro, resectable st Ill #melanoma: The phase 3 #NADINA trial #asco24 Dr.Blank Impressive PFS benefit of 2 cycles of neoadjuvant vs a standard of care adj approach. Benefit shorter duration of therapy Negative more iAE with CTLA4 https://t.co/Vfpsh2QUyI
Context: the primary endpoint was event-free survival (EFS) (NEJM 2024).
Today Christian Blank started a new American revolution in #melanoma! E pluribus unum, out of many trials, #NADINA will change practice immediately! Neoadjuvanté with ipi/nivo is here to stay! #ASCO24 https://t.co/42Sqn1DHnc https://t.co/rrlGGobn5h
Fabulous discussion on NADINA trial in melanoma by Dr. Kluger 👏🏽👏🏽👏🏽 Her first take away is 🔑 #ASCO24 #Melanoma @asco https://t.co/APE9i3uHpY
#ASCO24 💥 Plenary session @ASCO NADINA Trial: stage III melanoma Ipi+Nivo Neoadjuvant + Adjuvant according to pCR vs IQ+ Nivo Adjuvant 🗣️ Dr. Blank ✅ OS 1yr 83.7 vs 57.2% HR 0.32 Benefit across 🔪 Major pR: 59% ☣️ =>G3 29.7 vs 14% OS pending.. @OncoAlert @_SEOM @myESMO @VHIO https://t.co/oROdBFOldI
Context: 83.7% vs 57.2% (HR 0.32) are 12-month event-free survival, not overall survival; grade ≥3 systemic treatment-related adverse events were 29.7% vs 14.7% (NEJM 2024).
‼️ The first #neoadjuvant checkpoint inhibitor phase 3 trial in melanoma!#NADINA ‼️ Neoadj. nivo-ipi results in better EFS vs. SOC adj. (HR 0.32, p<0.0001) at 12 months regardless of BRAF status. #ASCO24 @ASCO @OncoAlert https://t.co/h8mmljY3d7
#ASCOPlenary #ASCO24 NADINA Phase 3 trial, incredible EFS advantage for neoadjuvant Ipi/Nivo for macroscopic stage 3 resectable melanoma when compared with adjuvant Nivo! A new SOC!!🔥🔥 https://t.co/Ti15rkzQhR
Amazing results from the NADINA trial by @ProfCUBlankNKI showing HR of 0.32 for EFS with neoadjuvant ipi/nivo vs. adjuvant nivo for clinical stage III melanoma and a 60% major pathological response. Neoadjuvant is the future for stage III melanoma patients. #ASCO24 https://t.co/9nQUvni9SK
@OncoAlert NADINA: EFS HR 0.32. 60% of patients needed only 6 weeks of treatment. Hard to argue that this isn’t the new standard of care for fit patients with clinical stage 3 disease. #Melanoma #ASCO24 @OncoAlert https://t.co/cKYiNdb9I8
@asco Plenary: NADINA -Pts with resectable melanoma randomized to neoadjuvant Nivo-ipi +/- adjuvant Nivo versus adjuvant Nivo -Improved EFS with neoadjuvant dual IO #asco24 @OncoAlert @BTFCancerNews https://t.co/fkZe0AbDw9
#ASCO24 Plenary Session NADINA: Less can be more effective‼️ Neoadj vs Adj 1y-EFS➡️84 vs 57% (HR:0.32) Neoadj MPR➡️59% No adj tdv in those who achieved MPR. About 60% patients received only 2 cycles of neoadj therapy. @OncoAlert https://t.co/p3oK2txLZ3
NADINA TRIAL- neoadjuvant ipi+ nivo is statistically superior to adjuvant ipi+ nivo by Christian Blank #ASCO24 https://t.co/mVKI4uGNTk
Context: the adjuvant comparator arm received nivolumab alone (NEJM 2024).
NADINA is probably only trial to compare neo adjuvant IO vs adjuvant IO head to head in solid tumors. And it will probably pave way for similar trials in other tumors . @asco #ASCO24 @Larvol @brunolarvol https://t.co/MexwSComVM
#ASCO24 plenary NADINA trial. Another patient centric nice trial testing de-escalation of therapy. Also, a clear explanation of statistical plan. We need to see such slides for all trials. https://t.co/V1siBe7kbI
Dr. @ProfCUBlankNKI at #ASCO24 shows NADINA: neoadjuvant immunotherapy > adjuvant in melanoma. Excellent RFS with greater pathological responses. We should take note in NSCLC! https://t.co/3pjEKO98Cs
Neoadjuvant checkpoint inhibitor is powerful. We have not adequately tested this concept in RCC and need to do so urgently! #ASCO24 https://t.co/DrZYjLM6e0
Plenary #ASCO24 @ASCO 📢🔥NADINA Neoadjuvant (nivo plus ipi and adj if not MPR vs adjuvant nivo in macroscopic stage III melanoma ✅12mo EFS: 83.7% vs 57.2% ✅regardless of BRAF status @OncoAlert https://t.co/kBLFqF3UMM
@OncoAlert 30% grade 3+ TRAE as is in line with prior trials @oncoalert https://t.co/SYDrFLpAGi
@OncoAlert Look at those curves!!! 67% relative risk reduction! Favors ipi/nivo in all subgroups. 59% major pathological response. Incredible 👏👏👏 https://t.co/21KrHh0Yke
EFS endpoint with OS as key secondary. 420 patients. #ASCO24 #melanoma @OncoAlert https://t.co/ubU9UpkbVq
Context: 423 patients underwent randomization (NEJM 2024).
NADINA Plenary presented by @ProfCUBlankNKI at #ASCO24. Significantly improved EFS benefit for neoadjuvant #melanoma treatment with ipi1/nivo3 over adjuvant PD-1. @OncoAlert https://t.co/KML3KAVbsf
NADINA Key Slides & Visuals
| Landmark | Neoadjuvant ipi + nivo (N=212) | Adjuvant nivo (N=211) |
|---|---|---|
| 12 months | 84.7% | 61.7% |
| 24 months | 77.5% | 53.7% |
| 36 months | 72.9% | 50.0% |
| Hazard ratio | HR 0.42 (95% CI 0.31–0.59), p<0.0001 |
| Subgroup | 12 mo | 24 mo | 36 mo | p |
|---|---|---|---|---|
| BRAF V600E/K: neoadjuvant (n=112) vs adjuvant (n=110) | 84.5% vs 59.9% | 75.2% vs 50.4% | 68.9% vs 46.9% | 0.00024 |
| BRAF wild-type & other: neoadjuvant (n=100) vs adjuvant (n=101) | 85.0% vs 63.5% | 79.9% vs 57.4% | 77.2% vs 53.4% | 0.0004 |
| Response | n | Treatment after surgery | RFS 12 / 24 / 36 mo | 3-year DMFS |
|---|---|---|---|---|
| pCR | 104 | none | 97.1% / 93.2% / 91.3% | 93.6% |
| near-pCR | 25 | none | 84.0% / 72.0% / 62.3% | 69.3% |
| pPR | 16 | adjuvant | 87.5% / 87.5% / 87.5% | 87.5% |
| pNR | 58 | adjuvant | 67.9% / 51.3% / 43.0% | 39.4% |
Same slides also posted by @anmwongNZ.
| Response | n | RFS | DMFS |
|---|---|---|---|
| pCR (0% viable tumor) | 104 | 95.1% | 98.0% |
| near-pCR (0.1–10%) | 25 | 69.4% | 78.5% |
| pPR (11–50%) | 16 | 81.2% | 81.2% |
| pNR (>50%) | 58 | 48.4% | 55.0% |
| Neoadjuvant | Adjuvant | HR neoadjuvant vs adjuvant (95% CI) | |
|---|---|---|---|
| IFN-γ high | 87.7% | 66.8% | 0.30 (0.14–0.65), p=0.002 |
| IFN-γ low | 65.4% | 36.6% | 0.40 (0.23–0.68), p<0.001 |
Same slides also posted by @MarioBalsaMD.
| Landmark | Neoadjuvant (N=212) | Adjuvant (N=211) |
|---|---|---|
| 12 months | 88.4% | 70.4% |
| 18 months | 85.7% | 62.4% |
| Events; adjusted HR | 29 vs 65 events | HR 0.37 (95% CI 0.24–0.57), nominal p<0.001 |
| Population | Neoadjuvant | Adjuvant | HR (99.9% CI) |
|---|---|---|---|
| ITT (28/212 vs 72/211 events) | 83.7% | 57.2% | 0.32 (0.15–0.66), p<0.0001 |
| BRAF V600E/K | 83.5% | 52.2% | 0.29 (0.11–0.79) |
| BRAF wild-type | 83.9% | 62.4% | 0.35 (0.12–1.03) |
| pCR | near-pCR | pPR | pNR |
|---|---|---|---|
| 95.4% | 94.1% | 76.1% | 57.0% |
NADINA in the News
Key KOL Sentiments - NADINA
NADINA Questions
What is the NADINA trial?
NADINA (NCT04949113) is an investigator-initiated, randomized phase 3 trial led by the Netherlands Cancer Institute, with Bristol Myers Squibb as collaborator and funder. It randomized 423 patients with resectable, macroscopic stage III melanoma to two cycles of neoadjuvant ipilimumab plus nivolumab followed by surgery and response-driven adjuvant therapy, or surgery followed by 12 cycles of adjuvant nivolumab. Design details: Trial Design.
What did NADINA show at ESMO 2026?
In the 3-year update (abstract 2076RO; data cutoff March 30, 2026; median follow-up 36 months), estimated 3-year event-free survival was 72.9% with neoadjuvant ipilimumab plus nivolumab vs 50.0% with adjuvant nivolumab (HR 0.42), and 3-year distant metastasis-free survival was 75.3% vs 57.4% (HR 0.46). Figures and data cuts: At a Glance.
How does NADINA relate to INTerpath-001?
The two trials enrolled different populations and cannot be compared directly. NADINA enrolled patients with macroscopic (clinically detectable) stage III melanoma before surgery. INTerpath-001 enrolled patients after complete resection of stage IIB–IV melanoma and added the individualized neoantigen therapy intismeran autogene to adjuvant pembrolizumab. At ESMO 2026 physicians debated whether adjuvant-only control arms remain relevant for macroscopic stage III disease now that NADINA has reported. See the INTerpath-001 profile and the ESMO 2026 discussion.
Is neoadjuvant ipilimumab plus nivolumab FDA approved for melanoma?
No. The current US labels for OPDIVO (nivolumab) and YERVOY (ipilimumab) do not include a neoadjuvant melanoma indication. Nivolumab is FDA approved as adjuvant therapy for completely resected stage IIB, IIC, III or IV melanoma (the NADINA control arm), and the combination is approved for unresectable or metastatic melanoma. Neoadjuvant use in resectable stage III melanoma is based on the NADINA results.
Who skipped adjuvant therapy in NADINA?
Patients in the neoadjuvant arm with a major pathologic response (pathologic complete or near-complete response, ≤10% viable tumor) received no adjuvant therapy; this was 59.0% of the neoadjuvant group in the primary analysis. Patients with a partial or non-response received adjuvant nivolumab (BRAF wild-type) or dabrafenib plus trametinib (BRAF V600E/K). Outcomes by response: At a Glance.
What were the safety findings?
Grade ≥3 adverse events related to systemic treatment occurred in 29.7% of the neoadjuvant group and 14.7% of the adjuvant group in the primary analysis; the ESMO 2026 update reported 31.6% vs 15.9%. Details: At a Glance.