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Pembrolizumab Approved by the EU for Relapsed/Refractory Classic HL

December 30, 2021

Pembrolizumab has been approved by the European Commission for the treatment of relapsed or refractory classic Hodgkin lymphoma (cHL) in adult patients whose disease has progressed after autologous hematopoietic cell transplantation and brentuximab vedotin, or who are transplant ineligible.

The decision to approve the anti-PD-1 monoclonal antibody was based on results from the phase II KEYNOTE-087 trial and phase Ib KEYNOTE-013 trial.

KEYNOTE-087 enrolled 210 adult patients with relapsed/refractory cHL who had been treated with a median number of four prior therapies; 81 percent of the cohort were refractory to at least 1 prior therapy. Patients received pembrolizumab 200 mg every 3 weeks until disease progression, intolerable adverse events, or a maximum of 2 years. The overall response rate was 69 percent (95% CI: 62.3-75.2) at a median follow-up of 10.1 months.

The other trial, KEYNOTE-013, enrolled 31 patients – 87 percent of whom were refractory to at least 1 prior line of therapy. Patients were treated with pembrolizumab 10 mg/kg every 2 weeks for as long as 2 years. The overall response rate was 58 percent (95% CI: 39.1-75.5).

The European Commission also evaluated safety data from 3,194 patients treated with pembrolizumab in various clinical trials in advanced melanoma, non-small cell lung cancer, or cHL. The studies reported that adverse events (of any grade) occurred in about 10 percent of patients. The most common were:

  • fatigue (22%)
  • pruritus (15%)
  • rash (13%)
  • diarrhea (12%)
  • nausea (10%)

The U.S. Food and Drug Administration approved pembrolizumab in March 2017 for adults and children with cHL who are refractory to treatment or who have relapsed after receiving three or more prior lines of therapy.

Source: Merck press release, May 5, 2017.


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