nivolumab
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Perioperative immunotherapy has reshaped treatment of resectable non-small cell lung cancer, but a randomized trial reported in JAMA found that adjuvant nivolumab given only after upfront surgery added nothing: median disease-free survival was 71.3 months versus 68.8 months with observation (hazard ratio, 0.97), and the trial was stopped for futility. The result sharpens the question of timing and patient selection. Work published in Nature identifies candidates most likely to gain from perioperative nivolumab: patients whose ctDNA cleared before surgery — 66% of nivolumab-treated patients with evaluable ctDNA, half of whom had a pathologic complete response — and patients with alterations in KEAP1, STK11, CDKN2A and/or SMARCA4, where nivolumab prolonged event-free survival (HR 0.48). How to integrate ctDNA clearance and the machine-learning predictor into routine selection remains unresolved.
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- medicalxpress.comPickNo disease recurrences after short course of neoadjuvant immunotherapy, according to follow-up
Long-term follow-up of NICHE-2 shows no disease recurrence among the 111 patients in the primary efficacy population with dMMR colon cancer treated with neoadjuvant nivolumab plus ipilimumab. In this single-arm, multicenter phase 2 study, patients received two cycles over about 4 weeks before surgery; the prior pathological response rate was 98%, with a pathological complete response rate of 68%. At a median postoperative follow-up of 58.7 months, 3-year DFS and estimated 5-year OS were both 100%, and all patients were alive at most recent follow-up.
- thelancet.comPick[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.
- clinicaltrials.govMRD and Imaging Guided Adaptive Neoadjuvant Therapy for Resectable NSCLC
- Mol Med RepNavigating 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.
- CancerPerioperative 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.
- doi.orgPerioperative 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.
- medicalxpress.comPickScientists 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.
- clinicaltrials.govNeoadjuvant RP2 + Nivolumab in Patients With Melanoma
- Nat MedBiography 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.
- nature.comBiography 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.
- aacrjournals.orgPickCellular 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.
- JAMAPickAdjuvant 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.
- NaturePickBiomarkers 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.
- x.comDr. Tina Cascone
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