Fast-track activation accelerates clinical trial for myelofibrosis and PV treatment

[Manouche]

med.stanford.edu/cancer/abo...

« The fast-track clinical trial is a phase I, first-in-human study evaluating a drug called INCB160058. This drug inhibits only the JAK2 V617F mutation without targeting the normal JAK2 gene. The study protocol initially evaluates drug tolerability and safety to identify the highest dose patients can tolerate without severe side effects. Once the right dose is identified, the study investigators hope that INCB160058 will be more effective and safe compared to the currently available JAK inhibitors used to treat myelofibrosis.

Gotlib ultimately hopes that this second generation of more highly targeted drugs, such as INCB160058, can be paired in future clinical trials with drugs that have different mechanisms to improve the survival of patients with these rare, poor-risk hematologic malignancies.

Stanford has treated four patients on the protocol and several more individuals have been identified for screening. Additional study sites have recently opened in the United States. The study is being conducted with the study sponsor Incyte Corporation, manufacturer of INCB160058.

[goodluckjoe]

Thank you for posting this! I have myelofibrosis with painful splenomegaly. My oncologist is putting me on Jakafi next month, but this new med sounds very promising.

[ETMF in reply to goodluckjoe]

Be aware that Jakafi can cause weight gain. I think it is that the spleen reduces its size then without the early saity as was before encourages over eating. Carbs are my downfall since being on Jakafi. As my venture near the 700-1 million still, RBC size is high, and hb hm neutrophils and others are low, I am still better feeling more days than not.

[goodluckjoe in reply to ETMF]

Thank you for replying! Did you have significant side effects? And how long have you been on Jakafi? I would be thrilled to gain weight as I only weigh 90 lb. It's so difficult to gain weight! My oncologist thinks Luspatercept added to Jakafi should boost hemoglobin. What do you think? Thanks again,!

[EPguy in reply to goodluckjoe]

Jakafi fixed my low weight problem. No change in eating habits nor hunger. I now have to watch the calories, a good problem for now. It took over a year to start this effect. So far no other obvious effects.

[ETMF in reply to goodluckjoe]

Always one day at a time. I have been on Jakafi for over a year. Started 10 mg 1x then2x perday. Followed up with 20 2x per day now 25 2x per day.

[goodluckjoe in reply to ETMF]

Thank you! Did you have splenomegaly? Any side effects from the Jakafi?

[ETMF in reply to goodluckjoe]

No spenomegaly, side effects are negligible.

[EPguy]

Great progress. This is the trial:

clinicaltrials.gov/study/NC...

It's US only for now.

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Inclusion Criteria:

Age ≥ 18 years

Participants with intermediate-1 or higher risk PMF, post-PV, of post-ET MF, histologically confirmed

Evidence of minimum burden of disease based on symptoms and/or splenomegaly

Life expectancy > 6 months

Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease)

Existing documentation of JAK2V617F mutation from a qualified local laboratory

Previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment