On 5th May 2017, pembrolizumab (KEYTRUDA®) was approved by the European Commission (EC) to treat adult patients with R/R cHL who progressed after receiving ASCT and brentuximab vedotin (ADCETRIS®), or who are transplant-ineligible and have failed brentuximab vedotin.
The approval is based on results of the phase Ib KEYNOTE-013 (NCT01953692) trial and the phase II KEYNOTE-087 (NCT02453594) trial, and follows a ‘positive opinion’ granted by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP), which the Lymphoma Hub reported on in March. Our previous report included results of the KEYNOTE-087 trial.
Key Highlights of KEYNOTE-013:
- Pts enrolled = 31 patients; 68% of pts had received ≥4 prior lines of therapy, 71% had failed prior ASCT, and all pts had progressed on prior brentuximab vedotin
- Pembrolizumab administered at 10mg/kg every 2 weeks for up to 2 years
- ORR = 64.5% (20/31); 5 CRs (16.1%); 15 PRs (48.4%); SD = 23%
- Median follow-up = 9.7 months
- Median DoR = not reached (range, 0–13.4+ months), with most responses (n = 14) ongoing at the time of the analysis
- At data cutoff, 45% of pts remained on therapy
Before awarding the approval, the EC also assessed safety data from 3,194 patients with advanced Melanoma, NSCLC, and cHL included in numerous clinical trials who were administered pembrolizumab at either: 2mg/kg every 3 weeks; 200mg every 3 weeks; or 10mg/kg every 2 or 3 weeks. All-grade AEs experienced by ≥10% of patients included fatigue (22%), pruritus (15%), rash (13%), diarrhea (12%), and nausea (10%). The most serious AEs documented were immune-related adverse reactions and severe infusion-related reactions.
Pembrolizumab (a monoclonal anti-PD-1 IgG4 antibody) is now approved in this indication in all 28 member states of the European Union as well as in Norway, Lichtenstein, and Iceland. Moreover, in March this year, pembrolizumab received an accelerated approval by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients with R/R cHL, which the Lymphoma Hub also reported on.
- Targeted Oncology. Pembrolizumab Approved by EU for Hodgkin Lymphoma. 2017 May 05. http://www.targetedonc.com/news/pembrolizumab-approved-by-eu-for-hodgkin-lymphoma. [Accessed 2017 May 08].