Pembrolizumab improves PFS in advanced classical Hodgkin lymphoma
Click Here to Manage Email Alerts
Pembrolizumab significantly extended PFS compared with brentuximab vedotin among patients with relapsed or refractory classical Hodgkin lymphoma, according to randomized phase 3 study results released by the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is approved in the United States for treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma who relapsed after three or more prior lines of therapy.
The open-label KEYNOTE-204 study compared pembrolizumab with brentuximab vedotin (Adcetris, Seattle Genetics), an antibody-drug conjugate directed at CD30, for adults with relapsed or refractory classical Hodgkin lymphoma.
The trial included 304 patients. Researchers assigned them to pembrolizumab dosed at 200 mg or brentuximab vedotin dosed at 1.8 mg/kg (maximum 180 mg per dose), each via IV on day 1 of each 3-week cycle. Treatment continued for up to 35 cycles.
PFS and OS served as primary endpoints. Secondary endpoints included objective response rate, complete remission rate and safety.
Results of an interim analysis conducted by an independent data monitoring committee showed pembrolizumab conferred a statistically significant improvement in PFS. Per the prespecified analysis plan, OS was not formally tested at this interim analysis.
The safety profile of pembrolizumab in this trial appeared consistent with that observed in prior studies. Investigators observed no new safety signals.
“Patients with classical Hodgkin lymphoma are generally young and, when they do not achieve remission following standard treatment, their cancer is challenging to treat,” Jonathan Cheng, MD, vice president of oncology clinical research at Merck Research Laboratories, said in a company-issued press release. “These data are strongly supportive of Keytruda’s current indication in classical Hodgkin lymphoma, and we plan to file these data with regulatory authorities as quickly as is possible.”
Results will be submitted for presentation at an upcoming medical meeting.
Pembrolizumab also is approved in the United States for treatment of certain patients with melanoma, lung cancer, head and neck cancer, primary mediastinal large B-cell lymphoma, urothelial cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma and microsatellite instability-high cancers.