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Discussing TGTX's Umbralisib UNITY-NHL Trial In wake of Rolling NDA Submission in Marginal Zone Lymphoma/Follicular LymphomaTicker(s): TGTX, BMY, BAYRY
A hematologist or oncologist with knowledge about TG Therapeutics’ pipeline in Lymphoma.
Please tell us about your clinical experience. How many patients with leukemia (MZL/ FL) do you currently treat? What treatments do you use?Added By: slingshot_insights
Please tell us about Umbralisib’s PI3Kδ/CK1ε pathway mechanism. In what patient circumstances would you recommend umbralisib? When would you choose it over Revlimid?Added By: slingshot_insights
Umbralisib has previously been granted BTD & ODD in MZL but not in FL. How important is this aspect? And what can you tell us about Bayer’s Aliqopa (copanlisib- also BTD ) in comparison to that?Added By: slingshot_insights
TG Therapeutics cites an improved tolerability profile over 1st generation compounds and a once daily dosing schedule vs twice daily for 1st generation compounds. Are those meaningful advances that you’d consider when prescribing a treatment? Have there been issues regarding tolerability/dosing in your other treatment plans before?Added By: slingshot_insights
Celgene’s lenalidomide (REVLIMID) has been approved in FL and MZL half year ago based on AUGMENT and MAGNIFY trial. Have you been using it? What’s your impression so far?Added By: slingshot_insights
In TGTX’s MZL trial, 86% of patients (36/42) had a reduction in tumor burden; median time to initial response was 2.7 months, and maximum percentage change from baseline SPD was on average 52% ORR/ 19% CR. What are your thoughts on this data?Added By: slingshot_insights
.In the same trial, there were 3 grade 3 infections reported (bronchitis, pneumonia, and influenza). How much of a concern is it to you?Added By: slingshot_insights
According to the company, R2 : recently approved Revlimid plus Rituxan– can cause severe neutropenia and rash and secondary malignancy risks • less than half of patients respond to Ibrutinib + tolerability issues • PI3K Delta inhibitors: 3 approved for FL but with tolerability issues. How true are those statements, judging from your experience?
What percent of your patients fail first-line therapies? What is your usual follow-up treatment plan?Added By: slingshot_insights
How likely would you be to put refractory FL or MZL patients on Umbralisib?Added By: slingshot_insights
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