Pembrolizumab yields encouraging results in advanced melanoma

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Takeaway

 

  • Pembrolizumab (Keytruda) provided promising antitumor activity in Japanese patients with advanced melanoma and a safety profile similar to that reported in other studies.

Why this matters

 

 

  • These early data support further clinical development for the use of pembrolizumab in this population.

Study design

 

 

  • A phase Ib study that evaluated the safety and antitumor activity of pembrolizumab in 42 Japanese patients with advanced melanoma (37 evaluable).
  • Funding: MSD K.K.

Key results

 

 

  • 75.7% (n=28) of the cohort had tumor shrinkage of varying degrees.
  • Overall response rate (ORR) was 24.1% for the 29 patients with cutaneous melanoma.
  • Median time to response was 12.3 wk, and median duration was not reached.
  • Of 7 patients who experienced a response, 5 (71.4%) have stayed progression-free.
  • Median PFS for the cutaneous melanoma cohort was 4.2 mo.
  • Of the 8 patients with mucosal melanoma, the ORR was 25.0% (n=2), and median time to response was 17.8 wk. Median duration has not yet been reached, and the 2 patients who responded remain progression-free.
  • Median PFS for the mucosal melanoma cohort was 3.4 mo.
  • 81.0% experienced at least 1 adverse event.

Limitations

 

 

  • Early-phase data.