Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial

Kirkwood, John M.; Del Vecchio, Michele; Weber, Jeffrey; Hoeller, Christoph; Grob, Jean-Jacques; Mohr, Peter; Loquai, Carmen; Dutriaux, Caroline; Chiarion-Sileni, Vanna; Mackiewicz, Jacek; Rutkowski, Piotr; Arenberger, Petr; Quereux, Gaelle; Meniawy, Tarek M.; Ascierto, Paolo A.; Menzies, Alexander M.; Durani, Piyush; Lobo, Maurice; Campigotto, Federico; Gastman, Brian; Long, Georgina V.

doi:10.1038/s41591-023-02583-2

Cited by 23 publications

(10 citation statements)

References 25 publications

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“…At a median follow-up of 16 months, the 12 months RFS was 89% in patients who were treated with nivolumab versus 79% in patients who received placebo (HR 0.42). 18 This superior outcome associated with nivolumab was seen across pre-specified patient subgroups including T category and stage. Based on the results from these two studies, both pembrolizumab and nivolumab were approved by the FDA and the European Medicines Agency for the treatment of patients with stage IIB/C melanoma.…”

Section: Adjuvant Immune Checkpoint Inhibitor Therapy For Patients Wi...mentioning

confidence: 95%

Adjuvant immunotherapy for melanoma patients: progress and opportunities

Sussman,

Ott

2024

ESMO Open

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Section: Adjuvant Immune Checkpoint Inhibitor Therapy For Patients Wi...mentioning

confidence: 95%

Adjuvant immunotherapy for melanoma patients: progress and opportunities

Sussman,

Ott

2024

ESMO Open

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“…The phase III, double‐blind, CheckMate‐76K trial assessed 790 patients with resected stage IIB/C melanoma. The patients were randomized 2:1 to receive nivolumab (480 mg) or placebo every 4 weeks for 12 months 10 . At 7.8 months of minimum follow‐up, nivolumab significantly improved RFS versus placebo, with a HR of 0.42 (95% CI, 0.30–0.59; p < 0.0001), with 12‐month RFS of 89.0% versus 79.4% and benefit observed across subgroups; DMFS was also improved (HR 0.47; 95% CI, 0.30–0.72).…”

Section: Summary Of Clinical Trial Datamentioning

confidence: 99%

Deciphering the role of adjuvant therapy in melanoma and its actual benefits

Fukushima,

Miyashita,

Kimura

et al. 2024

The Journal of Dermatology

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Numerous clinical trials have demonstrated a significant improvement in recurrence‐free survival among melanoma patients receiving high‐dose interferon‐α, immune checkpoint inhibitors (pembrolizumab, nivolumab), and BRAF/MEK inhibitors (dabrafenib‐trametinib). This study aimed to investigate whether these findings hold true in real‐world conditions for patients with stage III and IV melanoma. In particular, the study explores the efficacy and side effects of adjuvant therapies, focusing on anti‐PD‐1 antibodies and BRAF/MEK inhibitors. While clinical trials have shown comparable efficacy, differences in side‐effect profiles, especially the persistence of immune‐related adverse events with anti‐PD‐1 antibodies, highlight the need for careful consideration in adjuvant settings. In the absence of established biomarkers for guiding adjuvant therapy decisions, it becomes imperative to transparently communicate the advantages and disadvantages of drug administration to patients. The study also delved into the impact of melanoma subtype and BRAF mutation status on the effectiveness of adjuvant therapy, emphasizing the need for further investigation.

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“…Immunotherapy has emerged as a groundbreaking approach in the field of cancer treatment, 3 , 4 now revolutionising the way oncologists and surgeons approach curative cancer surgery. 5 – 7 One significant aspect of immunotherapy involves understanding the molecular landscape of tumours. High microsatellite instability (MSI-high) is a genetic marker that indicates a higher likelihood of response to immunotherapy.…”

Section: Circulating Tumour Dna and Immunotherapymentioning

confidence: 99%

Current and future genomic applications for surgeons

Alkhatib,

Miles,

Jones

et al. 2024

annals

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Genomics is a crucial part of managing surgical disease. This review focuses on some of the genomic advances that are available now and looks to the future of their application in surgical practice. Whole-genome sequencing enables unbiased coverage across the entire human genome of approximately three billion base pairs. Newer technologies, such as those that permit long-read sequence analysis, provide additional information in longer phased fragment and base pair epigenomic (methylomic) data. Whole-genome sequencing is currently available in England for cancers in children, teenagers and young adults, central nervous system tumours, sarcoma and haematological malignancies. Circulating tumour DNA (ctDNA), immunotherapy and pharmacogenomics have emerged as groundbreaking approaches in the field of cancer treatment. These are now revolutionising the way oncologists and surgeons approach curative cancer surgery. Cancer vaccines offer an innovative approach to reducing recurrence after surgery by priming the immune system to trigger an immune response. The Cancer Vaccine Launch Pad project facilitates cancer vaccine studies in England. The BNT122-01 trial is recruiting patients with ctDNA-positive high-risk colorectal cancer after surgery to assess the impact of cancer vaccines. The evolving landscape of cancer treatment demands a dynamic and integrated approach from the surgical multidisciplinary team. Immunotherapy, ctDNA, pharmacogenomics, vaccines, mainstreaming and whole-genome sequencing are just some of the innovations that have the potential to redefine the standards of care. The continued exploration of these innovative diagnostics and therapies, the genomic pathway evolution and their application in diverse cancer types highlights the transformative impact of precision medicine in surgery.

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Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial

Cited by 23 publications

References 25 publications

Adjuvant immunotherapy for melanoma patients: progress and opportunities

Adjuvant immunotherapy for melanoma patients: progress and opportunities

Deciphering the role of adjuvant therapy in melanoma and its actual benefits

Current and future genomic applications for surgeons

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