Data from the trial that led to the FDA approval demonstrated that Keytruda reduced the risk of progression or death in patients with relapsed or refractory classical Hodgkin lymphoma by 35%, compared to Adcetris.
The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab), an anti-PD1-therapy, for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL), according to the agent’s manufacturer, Merck.
“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,” said Vicki Goodman, vice president of clinical research at Merck Research Laboratories, in a company-issued press release. “Now patients with cHL who progress after frontline therapy have a new option in Keytruda, which has demonstrated a clinically meaningful improvement in progression-free survival compared to [Adcetris (brentuximab vedotin)].”
The agency based its decision on data from the randomized, open-label phase 3 KEYNOTE-204 trial, which included 304 patients with relapsed or refractory cHL. Patients were enrolled on the trial after receiving at least one multi-agent chemotherapy treatment. Participants were randomized 1:1 to receive either 200 mg of Keytruda, intravenously, every three weeks, or 1.8 mg/kg of Adcetris, intravenously, every three weeks.
Data from the trial demonstrated that Keytruda reduced the risk of progression or death by 35%, compared to Adcetris. Patients who received Keytruda also experienced an improved median progression-free survival, or time from randomization to first documented disease progression or death. Those in the Keytruda arm (151 patients) experienced a median progression-free survival of 13.2 months, compared with 8.3 months for the those in the Adcetris arm (153 patients).
The agency reviewed Keytruda 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 instance, there was a modified Project Orbis as the FDA is collaborating with the Australian Therapeutic Goods Administration and Health Canada for ongoing review.
The manufacturer noted that severe or fatal immune-mediated side effects, including, but not limited to, pneumonitis, colitis, hepatitis and complications of allogeneic hematopoietic stem cell transplantation could occur. Depending on the severity of the reactions, according to the manufacturer, Keytruda should withheld or discontinued and patients should receive corticosteroids if appropriate.
The agency also approved an updated indication for this drug for the treatment of children with refractory cHL, or cHL that has relapsed after at least two prior lines of therapy.
“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 Dr. John Kuruvilla, a hematologist at Princess Margaret Cancer Centre and associate professor of medicine at University of Toronto, in the release. “With this approval, Keytruda has the potential to change the current standard of care and help these patients achieve better outcomes.”