Expert Interview
Discussing Ukoniq(umbralisib) in Marginal Zone Lymphoma and Follicular Lymphoma and its future in light of recently announced FDA Investigation into Drug Safety, Risk of Death with Ukonic in UNITY CLL trial
Ticker(s): TGTXThe ideal expert would have clinical experience in treating patients with Marginal Zone Lymphoma and Follicular Lymphoma and be knowledgeable about the current literature pertaining to PI3 kinase inhibitors.
On a scale from 1-10 (10 being extremely excited), how would you rate your level of excitement for this drug?
Added By: sara_adminPlease tell us about your clinical experience. How many patients with leukemia (MZL/ FL) do you currently treat? What treatments do you use?
Added By: sara_adminWhat percent of your patients fail first-line therapies? What is your usual follow-up treatment plan?
Added By: sara_adminUmbralisib 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: sara_adminUNITY (CLL) trial design: Is Gazyva + Chlorambucil a relevant comparator?
Added By: user1ae2bf5fRelevance of PFS as primary endpoint rather than OS in UNITY CLL trial.
Added By: user1ae2bf5fAny additional concern about prescribing Ukoniq for MZL or FL due to the recent FDA announcement of investigation into its safety (prompted by FDA review of survival outcomes data with U2 CLL regimen containing Ukoniq in the UNITY trial)?
Will this new information change your prescribing?
OS Hazard ratio in UNITY was reported as 1.23 in favor of the control arm but not statistically significant. Is this trend concerning? Is the U2 drug combo still approvable?
Added By: user1ae2bf5fIn UNITY, the OS Hazard ratio was 1.04 (still going against U2 arm) when excluding Covid-related deaths. Is this reassuring?
Added By: user1ae2bf5fThoughts on efficacy results of UNITY in CLL?
Added By: user1ae2bf5fAre You Interested In These Questions?
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