The KEYNOTE-204 study showed that pembrolizumab is superior to brentuximab vedotin in terms of survival outcomes while maintaining a consistent safety profile in patients with relapsed or refractory classic Hodgkin lymphoma.
Results of the study will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (May 29-31, 2020).
PD-1 blockade through pembrolizumab monotherapy has demonstrated antitumor activity in relapsed or refractory classic Hodgkin lymphoma.
John Kuruvilla, MD, FRCPC, Princess Margaret Cancer Centre (Toronto, Canada), and colleagues designed the randomized, international, open-label, phase III KEYNOTE-204 study to compare the effectiveness of pembrolizumab vs brentuximab vedotin in patients with relapsed or refractory classic Hodgkin lymphoma. A total of 300 patients were randomized (1:1) to receive pembrolizumab monotherapy (200 mg IV Q3W; n = 148) or brentuximab vedotin monotherapy (1.8 mg/kg IV Q3W; n = 152). All patients had received prior autologous stem cell transplant or were ineligible for such transplant, had measurable disease, and an ECOG performance status of 0 or 1.
The primary endpoint of the study was progression-free survival (PFS) assessed by a blinded independent central review per International Working Group criteria, including clinical and imaging data after autologous stem cell transplant or allogeneic stem cell transplant.
After a median follow-up of 24.7 months, Dr Kuruvilla and colleagues observed statistically significant improvement in the pembrolizumab vs brentuximab vedotin arm for the primary PFS analysis (HR, 0.65; 95% CI, 0.48-0.88; P = .00271); twelve-month PFS rates were 53.9% vs 35.6%, respectively.
Additionally, researchers reported a lower percentage of grade 3-5 treatment-related adverse events in the pembrolizumab arm (19.6%) compared with the brentuximab vedotin arm (25.0%), though they acknowledged one death due to pneumonia in the pembrolizumab arm.
“In patients with relapsed or refractory classic Hodgkin lymphoma, pembrolizumab was superior to brentuximab vedotin and demonstrated statistically significant and clinically meaningful improvement in PFS across all subgroups, with safety consistent with previous reports,” authors of the study concluded, adding that these results support pembrolizumab for standard-of-care consideration in this population.—Zachary Bessette
