FDA expands Keytruda approval for classical Hodgkin lymphoma
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The FDA expanded the approval of pembrolizumab for treatment of classical Hodgkin lymphoma, according to the agent’s manufacturer.
The expanded approval authorizes use of pembrolizumab (Keytruda, Merck) as monotherapy for adults with relapsed or refractory classical Hodgkin lymphoma after front-line therapy, or for treatment of children with refractory disease or disease that relapsed after two or more lines of therapy.
The agency had previously approved pembrolizumab — an anti-PD-1 monoclonal antibody — for treatment of adults and children with refractory disease or those who relapsed after three or more prior lines of therapy.
Approximately 8,500 people in the United States — most of them aged 40 years or younger — are diagnosed with classical Hodgkin lymphoma each year.
“The patients with classical Hodgkin lymphoma 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,” John Kuruvilla, MD, hematologist and associate professor of medicine at Princess Margaret Cancer Centre and University of Toronto, said in a Merck-issued press release. “With this approval, Keytruda has the potential to change the current standard of care and help these patients achieve better outcomes.”
The FDA based the expanded indication for treatment of adults on results of the randomized phase 3 KEYNOTE-204 trial, results of which were presented during ASCO20 Virtual Scientific Program.
The trial included 304 adults (median age, 35 years; range, 18-84; 57% men; 77% white) with relapsed or refractory classical Hodgkin lymphoma who received at least one multiagent chemotherapy regimen.
Researchers randomly assigned 151 patients to pembrolizumab dosed at 200 mg via IV every 3 weeks. The other 153 patients received the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris, Seagen) dosed at 1.8 mg/kg via IV every 3 weeks.
Patients assigned pembrolizumab had received a median two (range, 1-10) prior therapies, whereas those assigned brentuximab vedotin had received a median three (range, 1-11) prior therapies.
Treatment continued until disease progression, unacceptable toxicity or completion of 35 cycles.
PFS assessed by blinded independent central review served as the main efficacy measure.
As Healio previously reported, results showed a 35% reduction in risk for disease progression or death among patients assigned pembrolizumab (HR = 0.65; 95% CI, 0.48-0.88). Median PFS was 13.2 months (95% CI, 10.9-19.4) in the pembrolizumab group and 8.3 months (95% CI, 5.7-8.8) in the brentuximab vedotin group.
The most common adverse events among pembrolizumab-treated patients included upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), pyrexia (20%), fatigue (20%), rash (20%) and cough (20%).
Thirty percent of patients assigned pembrolizumab experienced serious adverse reactions. These included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia and sepsis.
Fourteen percent of patients assigned pembrolizumab discontinued treatment due to adverse events — including 7% who discontinued due to pneumonitis — and 30% required pembrolizumab dosage interruptions due to adverse events.
Three patients (2%) died of causes other than disease progression. These included two who died of complications after allogeneic hematopoietic stem cell transplantation and one who died of an unknown cause.
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