Patients with myelofibrosis treated with fedratinib were treated primarily for progressive disease after ruxolitinib failure in the real-world setting. There were statistically significant reductions in spleen size and symptom burden after three and six months of treatment.
Hi I'm john Mascarenhas from the Icahn School of Medicine at Mount Sinai. Today I'll be presenting an abstract entitled clinical outcomes at three and six months of the dramatic therapy following prior Roxanne and failure. This is a real world assessment of spleen symptoms and pharmacologic response. Here are my disclosures so we know that mila fibrosis is a clonal malignancy involving the hematopoietic stem cells and progenitor cell population. Um And it is governed by jak stat hyperactivity. Uh It's predominantly seen in patients that are older in age. Um and a fraction of patients can be asymptomatic presentation. The dragon, which is a selective Jak two ft three inhibitor was approved in the United States in august of 2019 based on the Jakarta and Jakarta. Two studies randomized phase three studying in up front setting and and and and a single arm based to setting study in the second line setting to our knowledge. The data I'm presenting today is the first real world experience on outcomes of patients treated with Phaedra turnip after Russell admit failure. And here we're looking at responses at three and six months of time of initiation of federal. The way this study was done was utilizing a um a database from the cardinal health oncology provider Extended network which is a large network in the United States and using their electronic medical record with I. R. B. Approval to identify patients who had received federal funding with prior Rocks a Little therapy and here I show the inclusion and exclusion criteria for the study. Um And here's a slide describing the data abstraction that was used to um to develop the electronic case report forms for this study. So, a total of 150 patients were identified that were treated with hydrogen in after Russell and failure across 24 sites within this health network. The median duration of Russell in therapy was less than eight months. The median time to starting for dramatic after Russell and discontinuation was less than one month. And the median duration of hydrogen in therapy was approximately five months. The reasons for discontinuation of rock solid number listed in the blue box on the bottom and were predominantly progressive disease. At the end of the study period, about half the patients were still receiving for dragon nip in two thirds who had discontinued for Dragon IB had unfortunately died from progressive disease. Here are the patient characteristics at the time of starting to drop and it was predominantly an older patient population with a median age of 68. These were mostly primary milo fibrosis patients, 85% and mostly intermediate and high risk patients. The majority of patients had palpable spleen at time of initiation of federal. Um the starting dose in the majority of patients for at the time of initiation of the dragon was 400 mg daily, which is the package insert. Um and the reasons for Fredericton discontinuation as shown in this pie chart here. Um and are predominantly progressive disease. And approximately half the patient. About 20% of patients also came off for their own personal choices, which were never clear in these types of studies here. I'm showing the outcomes of federative therapy. Um I think the major points to get from this study uh and it's categorized by three months and then on the right six months um is that there was significant reduction in palpable spend immediately um at three months and then six months. So the median reduction of fundamentally three months was about 20% at six months was about 53%. Um And it was clear incremental reduction in spleen by palpitation at three and six months and there was an improvement in symptom burden as well. Um through the six month follow up. So there was a clear improvement in spleen and symptom burden in this rucks failure for dragon and treated population as well as stabilization of of blood counts. About half the patients had a reduction in their spleen size, 20% developed a non palpable spleen. Um And this waterfall plot gives you a sense of the spectrum of change of largest change. Um During federative treatment, So in conclusions, patients treated with Rajat nib um we're treated primarily for progressive disease after rock, splendid failure in the real world setting. Uh There were statistically significant reductions in spleen size and symptom burden after three and six months of treatment, including about 1/5 of the patients who had complete resolution of palpable spleen. A longer duration for dragon therapy resulted in greater clinical benefits in relation to these parameters. And this illustrates the real world benefit benefit for granted after russell them situation. Thanks for listening.