moving on to next treatment-considering Nurex

[Osprey69]

I have had CLL for 25 yrs with not the greatest genetics/markers TP 53, 13q unmutated. Have had multiple treatments FCR,Bent&R,Ibrutinib and most recently clin trial Loxo 305 (40 months) numbers are changing along with resistance (mut PLg2). I know several members are on degrader (nurex) trial and would appreciate their thoughts or other members on this clinical trial. I don’t expect URMD but perhaps a bridge to another clinical trial or drug combination. Thank you

[lankisterguy Volunteer]

Hi Osprey69,

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Here is more info on NURIX ir.nurixtx.com/news-release...

And the clinical trial details like locations & inclusion criteria: clinicaltrials.gov/study/NC...

SNIP: "Study Overview

Brief Summary:

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.

Detailed Description:

Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of NX-2127 at the dosage(s) selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL):

Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with no BTK C481 mutation

BTK C481 mutation-positive CLL/SLL

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Len

[Osprey69 in reply to lankisterguy]

Thanks Len need to understand alittle more about side effects, how many participants enrolled and what have been results so far. One of the things that appeals to me is the closeness of locality of one site (NIH) After driving 4 hrs each month to MSK for 40 months it got alittle wearing especially after the death of my husband . Fran

[lankisterguy Volunteer in reply to Osprey69]

Phase 1 trials are usually very small - like 12 people, and they often try many different dosages searching for the MTD- the highest dose that a few patients can tolerate before side effects are strong. There would be minimal information - if any - released publicly since they are searching for dose levels to use in Phase 2, where they would be looking for efficacy. See: brb.nci.nih.gov/techreport/...

cancer.org/cancer/managing-...

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Len

[steve5441]

Fran, I was on this Nurex trial for 19 months at MSK. It didn't give me any serious side effects, but my neutrophils were always low. I had to get neulasta shots EVERY month, and if you fall out of range they hold your dose. The drug worked quickly and my counts were always good on paper. An April BMB told a different story, 66% infiltration. To me it looks like the Nurex was good at scrubbing the easy to get stuff , but lacked the ability to get the hard to reach problems. I was off study on July 1 about 19 months total.

[Osprey69 in reply to steve5441]

Thanks Steve could you tell me the dose that you were on.? As I mentioned I have been on Loxo for 40 mo never got near MRD but gradually developed resistance (Alc 9) small increase in axillary) research team at MSK made decision to stop trial. I have had 4 other treatments but not Ven/Ob. My concern with my genetics P53 I will develop resistance/ mutation on this unless it is used in combination ( and that is question what and for how long) My personal story has changed with death of my husband so I am now geographically close to NIH. Had hx with them just providing blood samples 2x yr. so have seen Dr Weisner over yrs. They have Nurix trial there and my thoughts are perhaps this for a time for some of these trial of Ven & combinations to mature with data. Would be interested in your thoughts. Would also like to know how your trial is going if you feel like sharing. Thanks Fran