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Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.

  • Author(s): Hamid, Omid;
  • Robert, Caroline;
  • Ribas, Antoni;
  • Hodi, F Stephen;
  • Walpole, Euan;
  • Daud, Adil;
  • Arance, Ana S;
  • Brown, Ewan;
  • Hoeller, Christoph;
  • Mortier, Laurent;
  • Schachter, Jacob;
  • Long, Jianmin;
  • Ebbinghaus, Scot;
  • Ibrahim, Nageatte;
  • Butler, Marcus
  • et al.
Abstract

Background

Mucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).

Methods

Patients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.

Results

1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients.

Conclusion

Pembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.

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