ASH 2025 | The Phase II TaZa CLL study of tafasitamab plus zanubrutinib in newly diagnosed CLL

Frontline therapy in chronic lymphocytic leukemia is rapidly emerging. Recent data suggested high efficacy of acalabrutinib and venetoclax in treatment of CLL. There is, of course, BTK inhibitors approved in frontline therapy of CLL, zanubrutinib, acalabrutinib, and ibrutinib as continuous therapy. And with this, we are exploring additional options. So, there is data in relapsed/refractory CLL demonstrating efficacy of tafasitamab, a CD19 targeting monoclonal antibody, which is actually approved in lymphomas. But in CLL, we designed a study for patients with previously untreated CLL combining BTK inhibitors zanubrutinib and tafasitamab for these patients.
So, the study is designed as patients who complete two years of therapy can come off therapy if they achieve complete response. This study actually completed enrollment and received very high response rates. Essentially 27 patients were enrolled and all but one patient was evaluable for response. And essentially response occurred in all of these patients. The treatment is also well tolerated, and therefore we would be really interested to see longer follow-up, maybe in a couple of years once all patients complete therapy, to be able to report progression-free survival. But in the initial cohort of patients, of 17 patients that we present here, progression-free survival so far is over 90%. So, looking forward to additional results for this study to introduce this new option for patients with CLL.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.