ICML 2025 | ReVenG trial: safety & efficacy of venetoclax plus obinutuzumab retreatment in patients with R/R CLL

So venetoclax has become one of the mainstays of therapy in CLL and particularly in the front-line setting we use it in combination with obinutuzumab, the so-called ven-obin regimen, which is a one-year fixed duration treatment that can provide durable benefit for a lot of patients. But a major unanswered question in the field is how effective would venetoclax treatment be in a retreatment setting in those patients who previously received it in the frontline setting? We’re starting to see more and more of these patients in clinical practice now that the regimen has been available for a few years and so we’re studying these patients in a prospective trial called ReVenG and that stands for retreatment with VEN-G, which was the old name for obinutuzumab and so what we’re doing is we’re taking patients who had at least one year of remission from initial venetoclax and we’re retreating them with venetoclax obinutuzumab again if they had at least two years of remission from their frontline venetoclax, they just get one year of venetoclax retreatment. And if they only had one to two years of initial remission, then they get either 18 or 24 months of retreatment. And at this meeting, we presented some early data from the study. We have 25 patients recruited so far. I would say overall, the safety profile looks quite similar to what we see in the frontline setting with some grade three, four neutropenia and gastrointestinal side effects that are mild, but nothing out of line with what we expect from venetoclax. And the early efficacy data look promising. We have 15 patients who have reached the response evaluation time point of end of combination treatment plus three months, and all 15 patients have responded. Many of these patients have also achieved undetectable MRD, including six patients who achieved undetectable MRD at a threshold of 10 to the minus 6, suggesting a very deep response even at this very early response evaluation. I’d like to highlight that this study is ongoing and we’re actively accruing new patients with the goal of achieving a 75 patient sample size. So if you do have access to this study in your country, I’d highly recommend referring your patients.

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