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Ipilimumab alone or in combination with nivolumab in patients with advanced melanoma who have progressed or relapsed on PD-1 blockade: Clinical outcomes and translational biomarker analyses

Journal for ImmunoTherapy of Cancer, ISSN: 2051-1426, Vol: 10, Issue: 1
2022
  • 28
    Citations
  • 0
    Usage
  • 64
    Captures
  • 1
    Mentions
  • 1
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    28
  • Captures
    64
  • Mentions
    1
    • News Mentions
      1
      • News
        1
  • Social Media
    1
    • Shares, Likes & Comments
      1
      • Facebook
        1

Most Recent News

Selective Role for Single-Agent Ipilimumab After Anti-PD-1 Failure in Melanoma

— Two-year survival in second line for patients with BRAF/NRAS wild-type tumors Patients with wild-type metastatic melanoma that progressed on frontline PD-1 inhibition had almost

Article Description

Background There are no validated biomarkers that can aid clinicians in selecting who would best benefit from anticytotoxic T lymphocyte-associated antigen 4 monotherapy versus combination checkpoint blockade in patients with advanced melanoma who have progressive disease after programmed death 1 (PD-1) blockade. Methods We conducted a randomized multicenter phase II trial in patients with advanced melanoma. Patients were randomly assigned to receive either 1 mg/kg of nivolumab plus 3 mg/kg of ipilimumab or 3 mg/kg of ipilimumab every 3 weeks for up to four doses. Patients were stratified by histological subtype and prior response to PD-1 therapy. The primary clinical objective was overall response rate by week 18. Translational biomarker analyses were conducted in patients with blood and tissue samples. Results Objective responses were seen in 5 of 9 patients in the ipilimumab arm and 2 of 10 patients in the ipilimumab+nivolumab arm; disease control rates (DCRs) (66.7% vs 60.0%) and rates of grade 3-4 adverse events (56% vs 50%) were comparable between arms. In a pooled analysis, patients with clinical benefit (CB), defined as Response Evaluation Criteria in Solid Tumors response or progression-free for 6 months, showed increased circulating CD4+ T cells with higher polyfunctionality and interferon gamma production following treatment. Tumor profiling revealed enrichment of NRAS mutations and activation of transcriptional programs associated with innate and adaptive immunity in patients with CB. Conclusions In patients with advanced melanoma that previously progressed on PD-1 blockade, objective responses were seen in both arms, with comparable DCRs. Findings from biomarker analyses provided hypothesis-generating signals for validation in future studies of larger patient cohorts. Trial registration number NCT02731729.

Bibliographic Details

Friedman, Claire F; Spencer, Christine; Cabanski, Christopher R; Panageas, Katherine S; Wells, Daniel K; Ribas, Antoni; Tawbi, Hussein; Tsai, Katy; Postow, Michael; Shoushtari, Alexander; Chapman, Paul; Karakunnel, Joyson; Bucktrout, Samantha; Gherardini, Pier; Hollmann, Travis J; Chen, Richard O; Callahan, Margaret; LaVallee, Theresa; Ibrahim, Ramy; Wolchok, Jedd

BMJ

Medicine; Immunology and Microbiology; Biochemistry, Genetics and Molecular Biology; Pharmacology, Toxicology and Pharmaceutics

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