The FDA approved an expanded label for for pembrolizumab for adult patients with relapsed or refractory classical Hodgkin lymphoma.
The FDA has approved an expanded label for pembrolizumab (Keytruda, Merck), as an anti-PD-1 monotherapy for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
The FDA also approved an updated pediatric indication for pembrolizumab for use in pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. In clinical trials, pembrolizumab was found to significantly decrease the risk of death and extend progression-free survival (PFS).
“An estimated 8500 patients in the United States, many of them 40 years of age or younger, will be diagnosed with classical Hodgkin lymphoma this year. Now patients with classical Hodgkin lymphoma who progress after frontline therapy have a new option in pembrolizumab, which has demonstrated a clinically meaningful improvement in PFS compared with brentuximab vedotin,” said Vicki Goodman, MD, vice president, clinical research, Merck Research Laboratories, in a press release.
The approval was based on the phase 3 KEYNOTE-204 trial, which included 304 patients with relapsed or refractory cHL. Patients were randomized 1:1 to either receive 200 mg of pembrolizumab intravenously every 3 weeks or 1.8 mg/kg of brentuximab vedotin (BV) intravenously every 3 weeks. Treatment was continued until unacceptable toxicity, documented disease progression, or a maximum of 35 cycles of the treatment. Patient assessments were performed every 12 weeks.
The median PFS for those taking pembrolizumab was 13.2 months, compared with 8.3 months for those taking BV. According to the study, a complete response rate of 25% was observed in those taking pembrolizumab and 24% in those taking BV.
“The patients with cHL who do not achieve remission following initial treatment or who relapse after transplantation face a poor prognosis, reflecting the unmet need for improved therapies in the relapsed/refractory setting…With this approval, Keytruda has the potential to change the current standard of care and help these patients achieve better outcomes,” John Kuruvilla, MD, hematologist and associate professor of medicine, Princess Margaret Cancer Centre and University of Toronto, said in a press release.
According to the study, 14% of the participants discontinued pembrolizumab and 7% discontinued their treatments due to pneumonitis. Dosage interruption due to adverse effects occurred in 30% of patients.
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) [News Release] October 15, 2020; Kenilworth, NJ. https://www.merck.com/news/fda-approves-expanded-indication-for-mercks-keytruda-pembrolizumab-in-adult-patients-with-relapsed-or-refractory-classical-hodgkin-lymphoma-chl/. Accessed October 15, 2020.