Ask the expert Ohio state talk. Slide 46. PFS for treatment naïve patients on imbruvica Vs TN FCR patients.

[Hoffy]

There were only 31 patience on the imbruvica group in blue. This group had mutated and unmutated patients combined. Two were 17 P deleted as well. Unfortunately one of the 17p patients progressed after 4 months but the other I think has not progressed. A few people came off the trial for other reasons . This was discussed a bit in the webinar and I pulled this from other papers.

The treatment naïve FCR groups are broken down in the graph by mutated and unmutated

This was not a clinical trial but a combination of graphs from historical data. They admit it is not very scientific.

There are clinical trials going on now investigating this exact question. I think the flare trial in England is one of them.

Fortunately CLL is a slow-moving disease so it is hard to gather data quickly. As you can see even after six years with Imbruvica the whole picture is still developing.

This graph and others are discussed more in the talk That I posted on earlier today: healthunlocked.com/cllsuppo....

Link to associated post added by admin

[Hoffy]

Thanks for the help with the link in this post !

[AussieNeil Partner Administrator in reply to Hoffy]

The site automatically recognises nearly all web links. Just copy and paste the address and it should turn to a blue link in the submitted post/reply.

[Hoffy in reply to AussieNeil]

Neil,

I have the Power point presentation. I can change it to a PDF and up load it somewhere if you want for the group. Any idea where I should up loaded it? If not I could probably figure something out

[AussieNeil Partner Administrator in reply to Hoffy]

Probably best making it available to anyone interested via PM requests to you as you have offered elsewhere. Given enough demand and if copyright permissions permit, it's possible a copy could be provided on the cllsupport.org.uk website.

Thanks,

Neil

[Hoffy in reply to AussieNeil]

OK, I will wait to hear from people via PM to start,

thanks

[wroxham-gb]

Thanks for the video.

Sue

[nkferg]

It would be great if there were more patients in the study. 31 makes each patient worth 3.22%. It looks like only 3 patients progressed at 6 years and I believe the last one he said came off for non CLL reasons.

It would be nice if the larger treatment centers released their non-study numbers.

For me it is the graph on ibrutinib PFS in the relapsed setting. Only 40% remain at ~years, while 90% remain that used it front line. I think there is push back on imbruvica first line only due to cost. I am hoping when the 2nd gen BTKi drugs come out the competition will drive down the price.

[newyork8]

Well I wish we could fast forward 10 years and see if the Ibrutinib group hopefully still looks as good! Thats probably my treatment of choice coming up...unmutated del11. Thanks for the post.

[Hoffy in reply to newyork8]

I read 11Q Deleted people do very well on Ibruvica. Check out CLLSociety. com Brian is 11Q and has been on Ibruvica for 6 years.

[ikahan]

Thanks Huffy. The slide shows that CLL patients who are unmutated have low long term survival with FCR; mutated patients do much better, although not as well as with ibrutinib. The evidence is clear - in Canada, oncologists need to routinely check mutational status before starting treatment, and provincial funders should cover ibrutinib for unmutated patients. This will save many lives.

[Cllcanada Top Poster CURE Hero in reply to ikahan]

Quebec just turned down firstline funding of Imbruvica (ibrutinib) in patients not suitable for fludarabine.

The other provinces are in negotiations, likely start seeing decisions by the end of the summer.

Direct IGHV tests are being looked at , but until there are alternate first line therapies, CD38 /ZAP70 will probably suffice...

Many patients are involved in Canada through Lymphoma Canada and tbe CLLPAG.. we are trying to get changes inacted, but it is a slow process...

You can follow the approval process at tbe following link...

pcodr.ca/imbruvica-chronic-...

[kc1953 in reply to Cllcanada]

Is cost the reason certain provinces in Canada have been slow to adopt the small molecule oral CLL treatments? There is certainly enough scientific evidence to support their efficacy.

[Cllcanada Top Poster CURE Hero in reply to kc1953]

How fast the process goes, is totally up to the drug companies... they initiate Health Canada approval for a drug, then if they feel there is a market in managed healthcare, they apply to CADTH, to have the drug reviewed... Once drugs are HC approved, they are often available under private coverage, and sometimes SAP compassionate access, but it varies.

It goes through a length review process, then if the comittee feels there is an unmet need or the drug is superior, then they make their funding recommendations to the provinces. If the recommendation is positive, the the provinces enter into price negotiations with the drug company, and hopefully the drug is funded.

cadth.ca/pcodr/process-in-b...

Recently, Venetoclax went though this and it was turned down... so perhaps the company will try again in the future... I don't know...

Canada is a tiny market in CLL, companies may not move forward with drug approvals... ofatumumab languished for years.

Then some provinces run compassionate access programs and this adds another layer of complexity and variation from province to province...

My current treatment Zydelig (idelalisib) and rituxan is under Ontario's EAP ... Exceptional Access Program

health.gov.on.ca/en/pro/pro...

~chris

[jenxgen]

I'm on imbruvica as first line with Rituxan. I've just finished my 4th treatment. I did treatment 1xweekly for 4 weeks now I go to 1x monthly for next 11 months. I am taking 3 capsules daily of imbruvica. My swollen neck nodes are totally unpalatable on left side and barely palatable on the right. Largest was 3 cm by 3cm before treatment. I also had multiple swollen nodes in all areas of neck, auxiliary, and sub centimeter in lungs. My bone marrow was 73% lymphocytes as well. My nodal biopsy on 1/16/17 gave diagnosis of SLL. I'm stage IV. My oncologist at MDA feels I have decades to live as I am 51 with no other health issues. My dr offered FCR and BR as treatment options as well.

[newyork8]

Interesting. Are you part of a trial? Is adding Rituxan to Ibrutinib common? If not a trial, is insurance covering the combo? Thank u.

[Hoffy in reply to newyork8]

Fortunatley I am on a Clinical Trial out of UC San Diego combining Ibruvica and Venetoclax. They start with I for 3 months then add in V. I have been on I for 2 months. So Far so good. No major side effects and my nodes and counts are way down! And both drugs are covered by the trial. This trial is in many other cities too - I am told

[newyork8 in reply to Hoffy]

Thanks