Results presented at ASCO 2020 evaluated pembrolizumab versus brentuzimab vedotin
With clinically significant results, a phase III KEYNOTE-204 trial, presented at the ASCO 2020 Virtual Annual Meeting, evaluated the treatment of patients with relapsed / refractory classic Hodgkin’s lymphoma (R / R cHL) with pembrolizumab versus brentuximab vedotin (BV).
A total of 304 patients were randomized and 300 were treated: 148 for pembrolizumab 200 mg IV every 3 weeks and 152 for BV 1.8 mg / kg IV every 3 weeks. These patients were undergoing autologous post-transplantation or had not been eligible for transplantation.
The median time on treatment (interval) was 305.0 (1-814) and 146.5 (1-794) days with pembrolizumab and BV, respectively. There was a statistically significant improvement of the first versus the second in primary progression–free survival (PFS) analysis (HR 0.65; P = 0.00271]; median 13.2 versus 8.3 months). The 12-month PFS rates were 53.9% versus 35.6%, respectively. The benefit was observed in all subgroups tested, including patients without auto-SCT with autologous stem cell transplantation (autoSCT) (HR = 0.61), primary refractory disease (HR = 0.52), previous BV (HR = 0, 34) and without previous BV (HR = 0.67). The overall response rate was 65.6% for pembrolizumab and 54.2% for BV and the complete response rates were 24.5% and 24.2%, with a median response duration of 20.7 months and 13.8 months, respectively.
Grade 3-5 treatment-related adverse events occurred in 19.6% of patients with pembrolizumab and 25.0% with BV. One death occurred with pembrolizumab (pneumonia).
The conclusion of the trial showed that pembrolizumab was superior to brentuximab vedotin in patients with R / R cHL and demonstrated statistically and clinically significant improvement in PFS in all subgroups, with consistent safety with previous reports. Pembrolizumab monotherapy, therefore, should be the standard treatment for this population with R / R cHL.
J Clin Oncol 38: 2020 (suppl; abstr 8005)