Log in
CLL Support Association
12,054 members18,349 posts

Novel Bruton’s Tyrosine Kinase (BTK) inhibitor, ONO-4059 enters UK CLL clinical trial

A new BTK inhibitor enters the fray in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma.

ONO-4059 is currently being developed in a Phase I clinical trial for the treatment of B-cell malignancies.

A Phase I Study in CLL patients of ONO-4059

UK: Cardiff (Wales), Leicester & Plymouth (England)

France: Lille, Lyon & Montpelier

This is an open-label, multi-centre, phase I dose-escalation study to investigate the safety and tolerability of ONO-4059 given as monotherapy to patients with relapsed/refractory NHL and CLL. ONO-4059 will be administered orally, once daily(QD)as a flat dose, for up to maximum 12 cycles of treatment.

UKCTG: goo.gl/yo5dz4

Clinicaltrials.gov: goo.gl/zCkZU8

The UK trials landscape is fast changing as many novel targeted therapies enter UK trials:

UK Trials Gateway: goo.gl/vNg3Bj

UK NCRN CLL clinical trials map: goo.gl/OJPlJ8

6 Replies

Corr ! - yet another new drug possibility

Assume the company developing ONO-4059 is based in Japan.

Anybody any feel for what they might charge ultimately for this one (and others like it) - competition can only help us

It reminds me I would like to see a simple summary table of all the new drugs that we have heard of.

Interesting/maintainable place to locate that for me might be wikipedia as it would then link into some explanation (and some of the drugs already have their own pages and link into explanations of how they work and the systems they effect)

On the downside (although there are some edits this year) I think the Wiki entry for CLL needs some updating e.g. too many references, and some might not think "new drugs" (and medical research companies) fits in with the aims of an online encyclopedia.

Current page:


I'm also concious that the current Wiki/CLL doesn't now give an optimistic enough view of CLL so not the best place I think for new patients to land (I feel bad about that).

Wonder if we just started a new Wikipedia page (to tabulate the new drugs/treatments) from scratch if that might be a way to get started (not sure what the good folk at Wikipedia would think of that way of working)

Wonder alternatively if any of the people at HU HQ might have a view on this - challenge for a new feature perhaps (it needs to link to wiki though, to work well for me - to give me an idea how the treatment works)

Perhaps time for a Poll ?



All about ONO-4059


Celgene's, AVL-292 is much further ahead in trials than ONO, by the way.


1 like

Update on CC - 292 BTK inhibitor.

With an interesting video of Dr Jennifer Brown - Dana-Farber Cancer Institute, Boston, USA talking to ecancertv at ASH 2013 about the: "Phase 1 Study Of Single Agent CC-292,



It's good to know it's not just a two horse race.


News updates about ONO-4059 following presentation of early data from UK & France phase 1 trials with this second generation BTK inhibitor. It is showing impressive early results. This is an important development for UK patients, a competitor proving itself in the fray against Ibrutinib & AVL-292.

ONO - 4059 is a drug to follow over coming years as trials move forward through phases here in the UK. .


"NEW ORLEANS – Early data suggest that the second-generation oral BTK inhibitor ONO-4059 may give ibrutinib a run for its money in chronic lymphocytic leukemia."

"The majority of adverse events in the CLL patients were grades 1 and 2. There were no clinically significant bleeding events or bruising, and there was a low incidence of diarrhea and rash, Dr. Salles said."


"ONO-4059 had a favorable safety profile with a single dose-limiting toxicity observed in a patient who had Waldenstrom’s macroglobulinemia, was on the 320-mg dose, and was intolerant to all prior therapies. The maximum tolerated dose has not yet been reached."


Biotech strategy Blog http:

Ash2013, New Btk Iinhibito ONO 4059 shows early promise in CLL is it a future competitor to ibrutinib?


Trial details from UK Clinical Trials Gateway - Phase I Study of ONO-4059 Given as Monotherapy in Patients With Relapsed/Refractory NHL and CLL ukctg.nihr.ac.uk/trialdetai...

1 like

Ah, as soon as I saw Leicester (UK - I'm in Leicestershire and this is my local hospital) I realised this must be the work of my former consultant (whose laboratory receives grants from Gilead) who hinted at BTK inhibitors (I think) a couple of years ago.


For more detailed info: bloodjournal.org/content/ea... and bloodjournal.org/content/12...

At a glance it appears the trials are for relapsed CLL patients, but I will ask my consultant when I visit in October, and report back here!

Details of the trial: clinicaltrials.gov/show/NCT...


You may also like...