My name is Volker Diehl. I am Professor Emeritus. I was the director of the clinic for internal medicine here at the University of Cologne; and since 2003, I live in Berlin now, but I am still the Honorary Chairman of the German Hodgkin Study Group that I founded in 1978.
I want to speak about two ongoing studies with targeted therapy, especially a combination of chemotherapy, radiotherapy, and new drugs that we have in our hands. And the most important new construct of an antibody with a linker and chemical bump, our statin and tubulin inhibitor brentuximab vedotin, or Adcetris as it is called in the United States, and here is now combined in relapsed patients after transplantation and before transplantation to increase the response rate in relapsing and refractory patients. Here, I want to talk about two studies. One American study in frontline therapy in advanced patients of Hodgkin lymphoma, randomized open-label phase III trial with Adcetris, that is, brentuximab vedotin plus AVD, this is Adriamycin, Velban, and dacarbazine versus ABVD, Adriamycin, bleomycin, Velban, and dacarbazine frontline therapy for patients with advanced classical Hodgkin lymphoma. This trial compares the old standard chemotherapy ABVD six times with the addition of Adcetris leaving out the bleomycin because bleomycin plus Adcetris gives an enormous amount of cumulative pulmonary toxicity as what has been shown in phase I studies in the United States. This study is actually called ECHELON #1 study, and it is started by Millennium, the company that is taking care of the Adcetris, especially to compare the modified progression-free survival of patients with advanced Hodgkin lymphoma. And the key secondary response criteria is to determine whether Adcetris plus AVD improves the overall survival of advanced Hodgkin patients when we add the Adcetris. Minor secondary endpoints are to determine the safety of this drug combination and determine the efficacy for long-term disease survival and secondary endpoints like organ toxicity, secondary tumors, and so on.
The second trial I want to talk about is the German Hodgkin Study Group trial that uses the backbone of the escalated BEACOPP, and this trial addresses the question whether we can keep the high tumor response rate of more than 90% with escalated BEACOPP six times given to advanced Hodgkin patients, and we cut down the acute and long-term toxicity by leaving out the bleomycin and replacing bleomycin with brentuximab vedotin. So, we started a study here in Germany and PI is Peter Borchmann with BEACOPP where we just replaced the bleomycin with brentuximab and add etoposide, cyclophosphamide, Adriamycin, procarbazine, and prednisone, and we compared it in a randomized fashion with BrECAPP, and this is completely a new BEACOPP that is comprised of brentuximab instead of bleomycin. Vincristine is left out because often vinca alkaloid is cumulative toxic with the brentuximab to add to the neurotoxicity. We leave out the bleomycin because of the pulmonary toxicity, and we add etoposide, cyclophosphamide, Adriamycin, and dacarbazine instead of procarbazine cutting down the rate of infertility in young men and the leukemia rate by giving dacarbazine instead of procarbazine and leaving out the prednisone over 14 days and give dexamethasone only for five days. We have already included 70 patients. We want to enroll 100 patients and the primary endpoint is progression-free survival. Secondary endpoints are overall survival and safety and definitely quality of life for these patients in advanced stages getting an aggressive therapy.