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Expert Interview

Slingshot members are talking to an expert! The topic is:

Discussing TGTX's Umbralisib UNITY-NHL Trial In wake of Rolling NDA Submission in Marginal Zone Lymphoma/Follicular Lymphoma


Who's the expert?

A hematologist or oncologist with knowledge about TG Therapeutics’ pipeline in Lymphoma.

Interview Questions

Please tell us about your clinical experience. How many patients with leukemia (MZL/ FL) do you currently treat? What treatments do you use?

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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?

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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?

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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?

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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?

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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?

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.In the same trial, there were 3 grade 3 infections reported (bronchitis, pneumonia, and influenza). How much of a concern is it to you?

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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?

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 What percent of your patients fail first-line therapies? What is your usual follow-up treatment plan?

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 How likely would you be to put refractory FL or MZL patients on Umbralisib?

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