A follow-up to my last post on Tazemetostat, an newly approved EZH2 inhibitor:
At the same time it was approved by the FDA, a new test to detect EZH2 mutations was also approved. The test takes a DNA sample (the mutation is to a gene that is part of the DNA) and is able to find the mutation very quickly -- results will come in less than a day. If a mutation is detected, the patient would be eligible for Tazemetostat, and may benefit from it.
Another piece of FDA news: The makers of Umbralisib have submitted a Rolling New Drug Application for previously treated Follicular Lymphoma (and Marginal Zone Lymphoma, another indolent blood cancer).
A "Rolling Submission" for the FDA means the makers can submit parts of the application one at a time, rather than all at once. As you might guess, an FDA application is pretty large. Being able to submit parts of it, and get feedback tat can help with the other parts still to come, is a great advantage.
Umbralisib is a dual inhibitor of PI3 kinase-delta and CK1-epsilon
proteins, both of which are necessary for cancer cells to grow. The application to the FDA is based on results from the phase 2b UNITY-NHL trial, which looked at Umbralisib in combination with some other agents, in a few different types of Non Hodgkin's Lymphoma, including Follicular Lymphoma.
As always, we'll keep an eye on this one.
Subscribe to:
Post Comments (Atom)
4 comments:
Hi Bob
The ORR was 55%, consisting of 4 complete responses and 17 partial responses. Additionally, 11 patients (29%) achieved stable disease, with 6 of these patients still on treatment as of data cutoff. Overall, 58% of patients continued on treatment as of the data cutoff. The clinical benefit rate was 84% and tumor reductions were seen in 91% of patients.
The median time to response was 2.7 months and the median DOR was not reached. The PFS rate at 1 year was 71%.
Common (≥20%) adverse events (AEs) of any grade included diarrhea (45%), nausea (29%), fatigue (26%), headache (26%), cough (24%), and decreased appetite (21%). The most common grade 3/4 AEs were neutropenia (8%), febrile neutropenia (5%), and diarrhea (5%).
Source: https://www.targetedonc.com/view/umbralisib-monotherapy-reaches-orr-end-point-in-follicular-lymphoma-population-of-pivotal-nhl-trial
William
Today, Nordic Nanovector got Fasttrack on Betalutin. Small population, but pretty good orr, one-time only administration and supreme quality of life profile
Nordic Nanovector's LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) - the highest response rates of any patient sub -population in this study. This followed a once-only administration of Betalutin®
The above is the MZL cohort and only the interim analysis where NOT all patients were analyzed (full data is not public). FL data not yet presented at any conference or in any journal.
I think this has to be said to put into perspective to not mislead patients.
Yes -- I haven't commented on this because I've been looking for FL results. MZL is similar to FL in many ways, but definitely not the same thing. As the comment says, MZL group had the highest response rate in the trial, so I assume FL group was lower (maybe significantly lower, or the results would be more easily found). I'm still a fan of RIT in general, and I'd love to see Betalutin do well for FL, but the evidence isn't there yet (and I still have concerns about how widely it will be used, given Bexxar's fate).
Post a Comment