Dr Renata Walewska: "Hello and welcome from EHA from Madrid. Today was quite an interesting day. Today at CLL session we saw first time data presented from Sequoia RMD. RMD was including 17p deleted patients. We've seen RMC with zanubrutinib alone which is presented at EHA 2023. RMD included venetoclax with zanubrutinib so um zanubrutinib was led on with to avoid tumorlysis and actually we saw tumorlysis being reduced from high risk patients from 34.8% to 3%, medium risk from 60% to 71%, and low risk from 4.5% to 24%. Then venetoclax+zanubrutinib was given to up to 24 months. Now it can be stopped according to MRD stopping rules. So if patients achieved MRD to MRD to minus four and that MRD was repeated 12 weeks later patient could stop. Patients also could stop if there was unacceptable toxicity and obviously patient's choice.
So we've seen first um updates from this very interesting study - study in various high risk group of patients. The total patients who enrolled in study was 63. Three patients completed all treatment. There were, I think one patient who died, had a progressive disease, had to leave study, and two patients of had adverse events. So currently on treatment are 55 patients and the response rate are very impressive so we seeing complete response rate of 46% undetectable MRD 59% and 94% of progression free survival at 24 months. The main adverse events was neutropenia and diarrhea and the incidence of atrial fibrillation was 2%.
The other interesting um study I presented actually was a poster. This was a poster which is to help to get a reimbursement of zanubrutinib in 2nd line marginal zone lymphoma. Currently situation with marginal zone lymphoma we don't have a randomized studies so we don't have comparison from zanabrutnib to standard of care. And what we've done it's much adjusted comparison of we used the HMRN data set. This was a registry which is based in north of England, in Yorkshire. We took 94 patients trying to match with um zanubrutinib study. The zanubrutinib study for marginal zone lymphoma is Magnolia and also the Australian study AU-003 and it is interesting to compare to standard of care. Standard of care was rituximab monotherapy and also chemomimmunotherapy which is ituximab R-CVP so cyclophosphamide, vincristine and prednisolon, rituximab, bendamustine. And there was weighted patient so unfortunately with waiting we lost 56% of the patients so down to 30 old patients. But even with waiting and without waiting we've seen really impressive progression free survival in favor of zanubrutinib and also overall survival in favor of zanubrutinib. So hopefully this will obviously not replace clinical trial but there are no clinical trials planned for randomized data and hopefully that will help to gain access to zanubrutinib in 2nd line in marginal zone lymphoma. Thank you for your attention and hopefully we'll see you in next EHA".
Zapraszamy do obejrzenia nagrania.
