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ESMO Congress 2026

October 23–27, 2026 · Madrid · 3061 items

← Floor

nivolumab

★★★Late-breaking

31 people · 37 posts · 5 abstracts

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Heat now 8·Peak in the comparable set 8 (Oct 25 00:00)·Change over 24h in the comparable set –·Participants now 14

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Deep dive

The class standing of nivolumab as a PD-1 inhibitor was established by a series of published phase 3 studies: in previously treated advanced nonsquamous NSCLC, median overall survival was 12.2 months versus 9.4 months with docetaxel (HR 0.73) [1]; in the squamous population, 9.2 versus 6.0 months (HR 0.59) [2]; in previously untreated advanced melanoma, nivolumab plus ipilimumab achieved a median PFS of 11.5 months versus 2.9 months with ipilimumab alone [3], and in the BRAF wild-type population one-year overall survival was 72.9% versus 42.1% with dacarbazine [5]; in previously treated advanced renal-cell carcinoma it was 25.0 versus 19.6 months [4], and in platinum-pretreated squamous-cell carcinoma of the head and neck 7.5 versus 5.1 months [6].

At this ESMO26 there are two major readouts for this drug, one positive and one negative. The long-term NICHE-2 follow-up reported by Chalabi: 111 patients with locally advanced dMMR colon cancer received only 6 weeks of neoadjuvant nivolumab/ipilimumab followed by surgery, with zero recurrences at 5 years of follow-up and 100% overall survival, and many of these were high-risk stage III disease. The final results of the phase III ENERGIZE (CA017-078) reported by Necchi: in muscle-invasive bladder cancer (N=653), perioperative nivolumab plus gemcitabine/cisplatin versus chemotherapy alone showed a pCR of 39.1% versus 29.6% but the statistical threshold was not met, EFS HR 0.94 (p=0.67), OS HR 0.88 descriptive only, and grade ≥3 adverse events 73% versus 56%; ctDNA clearance was strongly prognostic for EFS and OS, but neither baseline ctDNA status nor clearance identified patients who derived greater benefit from nivolumab.

There are also several other data points involving the drug at this meeting: in a phase 3 study of HBI-8000 plus nivolumab versus nivolumab alone in advanced melanoma, mPFS was 11.7 versus 7.4 months (HR 0.73) and ORR 41.4% versus 32.3% (p=0.0569), but grade 3/4 treatment-related AEs were 54.8% versus 17.9% with 4 treatment-related deaths in the HBI-8000 arm; in the dMMR mCRPC subgroup of INSPIRE treated with nivolumab plus ipilimumab, ORR was 75%, PSA50 86%, and median PFS 32.7 months, while grade ≥3 treatment-related AEs occurred in 48% of the overall INSPIRE population; in EVOLUTION (ANZUP2001), 177Lu-PSMA-617 plus nivolumab/ipilimumab versus the radioligand alone showed 12-month rPFS of 47% versus 23% and median rPFS 12.0 versus 8.5 months, at the cost of grade 3-4 AEs of 75% versus 29% and treatment-related myocarditis of 7% in the combination arm, with trial recruitment stopped early. Postow will also present a poster on October 24 on real-world outcomes of neoadjuvant nivolumab plus relatlimab or nivolumab plus ipilimumab in resectable stage III melanoma, with no data disclosed yet.

Overall, NICHE-2 extends the benefit of short-course dual checkpoint neoadjuvant therapy in dMMR colon cancer from pathological response to 5-year zero recurrence and 100% overall survival, whereas CA017-078 shows that adding nivolumab to perioperative chemotherapy in unselected muscle-invasive bladder cancer failed to improve EFS, with the numerical pCR gain not translating into survival benefit and toxicity clearly increased. The limitations are equally clear: NICHE-2 is single-arm with no control group; the OS of CA017-078 is descriptive; the ORR difference for the HBI-8000 combination did not reach significance and OS is not disclosed; and the EVOLUTION and other Lu-PSMA combination data are cross-trial descriptive comparisons, not evidence that any combination is superior to VISION.

References
  1. 1.Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer · N Engl J Med 2015
  2. 2.Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer · N Engl J Med 2015
  3. 3.Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma · N Engl J Med 2015
  4. 4.Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma · N Engl J Med 2015
  5. 5.Nivolumab in previously untreated melanoma without BRAF mutation · N Engl J Med 2015
  6. 6.Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck · N Engl J Med 2016
Evidence
4736O

Results from a phase 3 trial of neoadjuvant (neoadj) chemotherapy alone vs in combination with nivolumab followed by postsurgical adjuvant nivolumab in patients (pts) with muscle-invasive bladder cancer (MIBC)

https://esmocongress.esmo.org
4757RO

Final pathological and radiological outcomes and initial EFS from a blinded, exploratory phase 2 trial of nivolumab ± visugromab in MIBC (GDFather-NEO)

https://esmocongress.esmo.org
LBA54

Primary analysis of HBI-8000-303: A randomized phase 3 trial of nivolumab plus HBI-8000 or placebo in advanced melanoma

https://esmocongress.esmo.org
NCT04884282NCT04884282

- **标题 / Title：** Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)

https://esmocongress.esmo.org
Floor
  7. Lancet

    Disease-free survival and overall survival after neoadjuvant immunotherapy in mismatch repair-deficient colon cancer in the Netherlands: results of the single-arm, multicentre, phase 2, NICHE-2 trial.

    At the data cutoff of June 19, 2026, the single-arm, multicentre phase 2 NICHE-2 trial showed that neoadjuvant ipilimumab plus nivolumab in locally advanced mismatch repair-deficient colon cancer achieved a 3-year disease-free survival of 100% (97.5% CI 100-100) and an exploratory 5-year overall survival of 100% (95% CI 100-100).

    Same topic nivolumab · 28 peopleipilimumabNo engagement yet
  8. medicalxpress.com

    No disease recurrences after short course of neoadjuvant immunotherapy, according to follow-up

    Long-term follow-up of NICHE-2 shows no recurrences among the 111 patients in the primary efficacy population with dMMR colon cancer treated with neoadjuvant nivolumab plus ipilimumab. In the single-arm, multicenter phase 2 study, patients received two cycles over about 4 weeks before surgery; pathological response was 98% and pathological complete response 68%. With median postoperative follow-up of 58.7 months, 3-year disease-free survival and estimated 5-year overall survival were both 100%, and all patients were alive at last follow-up.

    Same topic nivolumab · 49 peopleipilimumabNo engagement yet
  9. The Lancet

    [Articles] Disease-free survival and overall survival after neoadjuvant immunotherapy in mismatch repair-deficient colon cancer in the Netherlands: results of the single-arm, multicentre, phase 2, NICHE-2 trial

    The single-arm, multicentre, phase 2 NICHE-2 trial in the Netherlands showed that patients with locally advanced dMMR colon cancer who received ipilimumab and nivolumab before surgery had 3-year disease-free survival and 5-year overall survival of 100%. The authors consider that this neoadjuvant combination may become a standard treatment option for locally advanced dMMR colon cancer.

    Why it matters: The single-arm, multicentre phase 2 study reports 3-year DFS and 5-year OS of 100%, providing long-term follow-up reference for efficacy without a concurrent control.

    Same topic nivolumab · 49 peopleipilimumabNo engagement yet
  13. JAMA

    Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial.

    Adjuvant nivolumab after upfront surgery did not improve disease-free survival in resected non-small cell lung cancer. Median disease-free survival was 71.3 months with nivolumab vs 68.8 months with observation (hazard ratio, 0.97; 1-sided P = .39), and the trial was stopped for futility. This contrasts with the established benefit of preoperative and perioperative nivolumab in this setting.

    Why it matters: A negative phase 3 trial clarifies that adjuvant nivolumab adds no benefit after upfront surgery in resected NSCLC.

    Same topic nivolumab · 28 peopleNo engagement yet
  14. Nature

    Biomarkers of nivolumab benefit in resectable non-small cell lung cancer.

    Pre-surgical ctDNA clearance identifies patients most likely to benefit from perioperative nivolumab in resectable NSCLC: 66% of nivolumab-treated patients with evaluable ctDNA cleared it before surgery, and half of those had pathologic complete response, versus 38% clearance and 12% pCR on placebo. Nivolumab also prolonged EFS in patients with alterations in KEAP1, STK11, CDKN2A and/or SMARCA4 (HR 0.48, 95% CI 0.28-0.83). A machine-learning model ranked ctDNA clearance among top predictors of longer EFS.

    Why it matters: Defines ctDNA-based markers that predict benefit from perioperative nivolumab in resectable NSCLC.

    Same topic nivolumab · 28 peopleNo engagement yet
  16. Mol Med Rep

    Navigating the landscape of targeted therapies for renal cell carcinoma in the era of precision medicine (Review)

    This review integrates the molecular mechanisms of renal cell carcinoma (RCC) with phase III clinical evidence, systematically evaluating the therapeutic landscape of VEGF-TKIs, mTOR inhibitors, immune checkpoint inhibitors as monotherapies, and combination regimens including nivolumab plus ipilimumab, pembrolizumab plus axitinib, and lenvatinib plus pembrolizumab.

    Same topic nivolumab · 49 peopleNo engagement yet
  17. Cancer

    Perioperative immunotherapy in head and neck squamous cell carcinoma

    Perioperative immunotherapy in resectable head and neck squamous cell carcinoma (HNSCC) has reached a key phase III milestone: adjuvant nivolumab improved DFS in patients with pathologic high-risk resected disease, and perioperative pembrolizumab significantly prolonged EFS in locally advanced disease. Biological evidence supports integrating immunotherapy into perioperative strategies to improve long-term outcomes.

    Same topic nivolumab · 49 peopleNo engagement yet
  19. doi.org

    Perioperative immunotherapy in head and neck squamous cell carcinoma

    Perioperative immunotherapy for resectable head and neck squamous cell carcinoma (HNSCC) has reached a turning point, with two phase III trials reporting positive results: adjuvant nivolumab improved disease-free survival (DFS) in HNSCC with pathologic high-risk features after resection, and perioperative pembrolizumab significantly prolonged event-free survival (EFS) in resectable locally advanced HNSCC. These data are driving a shift from conventional adjuvant frameworks toward integrated perioperative immunotherapy strategies, with the potential to improve long-term patient outcomes.

    Same topic nivolumab · 49 peopleNo engagement yet
  20. medicalxpress.com

    Scientists identify clues to making immunotherapy more effective against glioblastoma

    Neoadjuvant nivolumab plus ipilimumab extended median survival to about 13.5 months versus roughly nine months with nivolumab alone in a phase 2 trial of 63 patients with recurrent glioblastoma. Five patients, about 15% of the combination group, became long-term survivors, with none on nivolumab alone. Tumor T-cell density independently predicted overall survival, and early pseudoprogression on MRI correlated with longer survival, pointing to biomarkers for patient selection.

    Why it matters: Dual checkpoint blockade produced long-term survivors in recurrent glioblastoma, a cancer largely resistant to immunotherapy.

    Same topic nivolumab · 49 peopleNo engagement yet
  21. Nat Med

    Biography of an inherited lung cancer risk gene.

    A study drawing on data from over 3 million people traces the ancestral history of the EGFR T790M germline mutation and its present contribution to lung cancer risk in people who never smoked. Rare germline variants of EGFR, especially T790M, have been implicated in familial lung cancer, but prior studies were small and lacked statistical power. As smoking-related lung cancer declines in many regions, lung cancer in never-smokers is drawing more attention.

    Same topic nivolumab · 28 peopleEGFRNo engagement yet
  22. Nature Medicine

    Biography of an inherited lung cancer risk gene

    A study using data from more than 3 million people reveals the ancestral history of the EGFR T790M germline mutation and its present contribution to lung cancer risk in never-smokers. Overcoming the limited statistical power of earlier small studies, it offers new insight into inherited susceptibility to lung cancer in people who never smoked.

    Same topic nivolumab · 28 peopleEGFRNo engagement yet
  24. Cancer Discovery

    Cellular Neighborhoods Govern Antitumor T-cell Infiltration Following Anti–CTLA-4 in Melanoma with Primary Resistance to Anti–PD-1

    Spatial proteomics of biopsies from the SWOG S1616 trial shows that melanoma patients responding to ipilimumab plus nivolumab after primary resistance to anti-PD-1 have activated CD8 T-cell networks near melanoma cells, while progressing biopsies show impaired T-cell infiltration adjacent to plasma cells. Responding baseline biopsies also showed complement expression in myeloid cells, interferon pathways in endothelial cells, and oxidative phosphorylation and lipid metabolism in melanoma cells. The work defines tumor microenvironment features that accompany reversal of anti-PD-1 resistance.

    Why it matters: It explains, at single-cell spatial resolution, why some anti-PD-1-resistant melanomas respond to added anti-CTLA-4 and others do not.

    Same topic nivolumab · 28 peopleNo engagement yet
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