ASH 2020 | Obinutuzumab plus venetoclax in early R/R DLBCL
Ulrich Jäger, MD, Medical University of Vienna, Vienna, Austria, discusses the Phase II AGMT NHL15B study (NCT02987400) evaluating the effect of a combined obinutuzumab and venetoclax treatment in refractory or early relapse diffuse large B-cell lymphoma (DLBCL). The treatment was well tolerated among participants and no dose-limiting toxicities were reported. The objective response rate (ORR) was 38.1%, with 23.8% of the patients achieving a complete response (CR). The response duration was 83.3% at 84 days, with a progression-free survival (PFS) of 38.8% and an overall survival (OS) of 59.3% at 168 days. These findings suggest that this therapy regimen can create a response period of approximately 3 months, providing a window of opportunity for relapse or bridging treatment in preparation for stem cell or chimeric antigen receptor (CAR)-T cell therapies. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Transcript (edited for clarity)
I present on behalf of my colleagues from the AGMT the data from the NHL15B study. This was a study for early relapsing or refractory aggressive B-cell lymphoma patients. And the idea here was to treat these patients with a chemo-free combination with obinutuzumab and venetoclax, number one, to get responses in patients who are not eligible for transplant, but on the other hand, one of the end points of the study was to bring these patients in a condition of where they could be transplanted or they could receive CAR T-cell treatment...
I present on behalf of my colleagues from the AGMT the data from the NHL15B study. This was a study for early relapsing or refractory aggressive B-cell lymphoma patients. And the idea here was to treat these patients with a chemo-free combination with obinutuzumab and venetoclax, number one, to get responses in patients who are not eligible for transplant, but on the other hand, one of the end points of the study was to bring these patients in a condition of where they could be transplanted or they could receive CAR T-cell treatment. That’s of course an endeavor where you do not expect that you get long-term responses, so you create a window-of-opportunity where then you can transplant patients or bring them to the next level of therapy.
We included 21 patients, and the objective response rate was 38%, which is quite remarkable with a CR rate of 23.8%. What’s important is that these responses were of a rather short duration, so you can expect three to four months response. But there were seven responding patients eligible for transplant, then in the end seven patients received cellular therapy, three of those patients received an autologous stem-cell transplant, and four patients received CAR T-cell treatment.
So it seems that for certain selected populations, you can probably use this treatment as a bridging therapy to further treatment. And we tried to find subgroups who did respond, so the patients who responded had low R-IPI, either very good or good, seven of eight had that, and seven of eight only had one previous lines or line of therapy, and among the patients with R-IPI, very good or good, they were five CR. So good risk patients clearly respond to this type of treatment and genetic analysis is currently underway to define further predictive factors. So in conclusion, we show that this type of chemo-free regimen is able to bring approximately one third of patients in response, and if we knew who responded then we could use this treatment for certain selected patients with a very low toxicity, I have to say.
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Disclosures
Prof. Ulrich Jäger, MD, has received research support from Bioverativ and Roche and has received honoraria for lecturing or advisory boards from AbbVie, Bioverativ, Gilead, Janssen, Mundipharma, Novartis, Roche and Sandoz.
