FDA Approves Pembrolizumab for Relapsed/Refractory Classical Hodgkin Lymphoma

FDA Approves Pembrolizumab for Relapsed/Refractory Classical Hodgkin Lymphoma

The FDA approved pembrolizumab (Keytruda) for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL), according to Merck, the manufacturer of the anti-PD-1 therapy.

“An estimated 8,500 patients in the U.S., many of them 40 years of age or younger, will be diagnosed with cHL this year. Now patients with cHL who progress after frontline therapy have a new option in [pembrolizumab], which has demonstrated a clinically meaningful improvement in progression-free survival compared to brentuximab vedotin,” said Vicki Goodman, vice president, clinical research, Merck Research Laboratories, in a statement.

The approval is based on findings from the phase 3, randomized, open-label, active-controlled KEYNOTE-204 trial, which included 304 patients with relapsed or refractory cHL. All patients on the trial had at least 1 multi-agent chemotherapy treatment. Participants were randomized 1:1 to receive either 200 mg of pembrolizumab, intravenously, every 3 weeks, or 1.8 mg/kg of brentuximab vedotin, intravenously, every 3 weeks.

Findings showed that pembrolizumab reduced the risk of progression or death by 35% compared to brentuximab vedotin. The immunotherapy agent also improved median progression-free survival (PFS). Average PFS was 13.2 months for patients in the pembrolizumab arm, and 8.3 months in the brentuximab vedotin arm.

The FDA reviewed pembrolizumab for this indication under their Project Orbis, which allows for simultaneous submission and review of cancer drugs among the FDA Oncology Center of Excellence’s international partners. In this particular instance, there was a modified Project Orbis as the FDA is collaborating with the Australian Therapeutic Goods Administration and Health Canada for ongoing review.

Severe immune-related adverse events that oncology nurses should look out for include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications with allogeneic hematopoietic stem cell transplant. If a patient experiences any of these, pembrolizumab should be withheld or treatment should be stopped and the patient should be given corticosteroids, if needed.

“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,” said John Kuruvilla, MD, hematologist and associate professor of medicine, Princess Margaret Cancer Centre and University of Toronto. “With this approval, [pembrolizumab] has the potential to change the current standard of care and help these patients achieve better outcomes.”