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EHA 2025 | The OLYMP-1 trial: efficacy and safety of obinutuzumab monotherapy as a first-line treatment for MZL
In this interview, Christian Buske, MD, University Hospital Ulm, Ulm, Germany, presents the results of the OLYMP-1 trial (NCT03322865), highlighting that encouraging disease control was observed with obinutuzumab monotherapy in treatment-naive patients with marginal zone lymphoma (MZL). Overall, the results demonstrate the potential of this chemotherapy-free approach; however, Prof. Buske notes that infection-related deaths were observed in this trial, suggesting that anti-CD20 antibody treatment may be associated with a risk of infection. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
Yeah, so the idea of this trial was to test whether we can offer patients a treatment without chemotherapy and I think we have seen in marginal zone lymphoma that rituximab chemotherapy, obinutuzumab chemotherapy, for instance G-Benda or R-Benda can be quite toxic for patients. So the idea was in this trial just to offer the patients simply obinutuzumab single agent, so in treatment naive patients, it was a single arm Phase II study in Germany with 56 patients...
Yeah, so the idea of this trial was to test whether we can offer patients a treatment without chemotherapy and I think we have seen in marginal zone lymphoma that rituximab chemotherapy, obinutuzumab chemotherapy, for instance G-Benda or R-Benda can be quite toxic for patients. So the idea was in this trial just to offer the patients simply obinutuzumab single agent, so in treatment naive patients, it was a single arm Phase II study in Germany with 56 patients. So we predefined actually the distribution between the different marginal zone lymphoma subtypes. So 50% of the included patients had extranodal marginal zone lymphoma, 25% splenic and 25% nodal marginal zone lymphoma. So the treatment consisted of obinutuzumab single agent induction for six months and then a two years maintenance every eight weeks with obinutuzumab.
And so what we have seen is that with this very simple treatment, we can achieve a very good disease control. So we had in the total population an overall response rate of over 80 percent, the highest in splenic marginal zone lymphoma with over 90 percent. And we had in the extranodal subpopulation a complete remission in every second patient. And when we are looking at progression-free survival at two years, over 90% of the patients were still progression-free.
What we also saw was that we had deaths, fatal infections. We have to mention that this was a trial done during the COVID-19 pandemic, but it also demonstrates that with prolonged anti-CD20 treatment, you have a certain risk of infections also seen in this trial. But in total, I think a very simple treatment, chemotherapy-free and excellent disease control.
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