John Kuruvilla, MD, on Key Findings from the Phase 3 KEYNOTE-204 Trial

June 13, 2020

The expert in hematology suggested that these findings represent a clinically meaningful benefit for patients that received pembrolizumab in the study, compared to those who received brentuximab vedotin.

In an interview with CancerNetwork®, John Kuruvilla, MD, of the Princess Margaret Cancer Centre, discussed the study design of the phase 3 KEYNOTE-204 trial and the key findings from the trial.

Results from the randomized, open-label, phase 3 study, presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, demonstrated that pembrolizumab (Keytruda) was superior to brentuximab vedotin (Adcetris) in patients with relapsed or refractory classic Hodgkin lymphoma.

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KEYNOTE-204 is a large, randomized, international, open-label, phase 3 trial in patients with relapsed and refractory Hodgkin's lymphoma that compares pembrolizumab, once every 3 weeks, with brentuximab vedotin given once every 3 weeks. In terms of the key inclusion, relapsed or refractory Hodgkin's lymphoma generally consisted of 2 different patient populations. The first was patients that have had autologous stem cell transplants and have had disease progression after the transplant. The second group of patients were patients that had had prior therapy for their lymphoma but had not been able to have a transplant for whatever reason.

The primary end point of the study was progression-free survival. And so, this was met with pembrolizumab, showing a statistically significant and very clinically meaningful improvement over brentuximab vedotin. So, the hazard ratio ended up being around 0.65. The median progression-free survival for pembro was a little over 13 months and was around 8 months for brentuximab. And so that represents, I think, a clinically meaningful benefit for the patients that got pembrolizumab in the study.