DR FRIEDBERG: So brentuximab vedotin obviously, I think, has really changed the way we think about relapsed Hodgkin lymphoma. This was an agent that was approved by the FDA for use in patients who relapse after an autologous transplant. And in that group of patients, the response rate exceeded 70%. About half of those patients obtained complete responses. And for that group of patients, the durability is quite long. I have a patient who was on the original pivotal trial who remains free of disease. He’s been at least 3 years now out of treatment. And it begs the question as to whether it might even cure some patients.
Obviously, when you have such an active single agent in a refractory situation, there’s interest in moving it up front and, therefore, a group of investigators did get together and perform a Phase I study trying to incorporate this with ABVD. The original study had to be modified because of overlapping pulmonary toxicity observed when bleomycin and brentuximab were given together.
When the bleomycin was removed and the brentuximab was essentially substituted for bleomycin, that regimen was very well tolerated. And, of course, it’s hard to look at efficacy in a Phase I trial, but there was certainly a signal that the PET-negative rate and durability looked quite favorable.
For that reason, the sponsor has opened a global, randomized trial of the standard ABVD regimen compared to the AVD with brentuximab vedotin regimen. We’re participating on that trial. We’ve actually enrolled 7 patients already on that trial. There’s great interest of the patients to enroll on this trial, and I think it’ll be very interesting to see the results. This is a study for all patients with advanced-stage Hodgkin lymphoma. And it will take a couple of years to accrue, given the ambitious goal that they have for the number of patients on the study.