Melanoma: nivolumab + ipilimumab shows benefit for brain mets

  • Tawbi HA & al.
  • N Engl J Med
  • 23 Aug 2018

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • An open-label, phase 2 trial suggests that nivolumab combined with ipilimumab is associated with a 57% intracranial clinical benefit rate in patients with melanoma with untreated brain metastases.

Why this matters

  • Combined nivolumab and ipilimumab may represent a future treatment for patients with melanoma with brain metastases, a common cause of neurologic complications and death.

Key results

  • Intracranial clinical benefit rate was 57% (95% CI, 47%-68%).
  • Extracranial clinical benefit rate was 56% (95% CI, 46%-67%).
  • Intracranial complete and partial response rates were 26% and 30%, respectively.
  • Proportion with stable intracranial disease for ≥6 months was 2%.
  • Clinical benefit rate was higher among patients with lactate dehydrogenase levels above the upper limit of normal (ULN) and patients with tumor programmed death ligand 1 (PD-L1) expression ≥5%.
  • 55% of patients experienced grade 3-4 treatment-related adverse events (7% affecting the central nervous system).

Study design

  • 94 patients with melanoma from 28 centers with ≥1 nonirradiated brain metastasis and no neurologic symptoms were treated with nivolumab and ipilimumab until progression or unacceptable toxic effects.
  • Funding: Bristol-Myers Squibb; National Cancer Institute.

Limitations

  • Phase 2 study with small patient sample size and without control patients.

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