The combinations are here...

[MovingForward4423]

The future is getting very bright for CLL patients.

Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Taking these results together, the researchers concluded that MRD-guided fixed-duration therapies combining obinutuzumab with venetoclax or ibrutinib can induce “deep and durable remissions” in patients with high-risk genetics, and these remissions can persist after treatment discontinuation.

Now I wonder how those of us on Ibrutunib can move onto a combination so we have hope of being treatment free for at least a period of time.

[Jm954 Administrator]

In England, NICE have said that they are going to do an appraisal of this combination next year. Things are indeed moving forward but I'm not sure it will apply to those already taking Ibrutinib.

Jackie

[annmcgowan in reply to Jm954]

Hi Jackie do you know why this may not apply to people on ibrutinib?Ann

[Jm954 Administrator in reply to annmcgowan]

Ann,

MovingForward4423 is right that NICE will only approve treatments or combinations if there is the evidence to support their use and those trials have not been done and are unlikely to be undertaken.

Even if they started a trial now it could be 5 years before NICE felt the evidence was mature enough to trust it for the basis of a decision regarding cost effectiveness.

Jackie

[annmcgowan in reply to Jm954]

Thank you Jackie.Ann

[MovingForward4423 in reply to Jm954]

It won't they will have to run a trial to move monotherapy to combinations. That's because we are pre-treated and results may be different to untreated patients. It's frustrating because those trials can take many years... There are options to add antibodies to pretreated Ibrutnib patients who have low levels of CLL cells.

[Jm954 Administrator in reply to MovingForward4423]

You may be able to add Venetoclax to Ibrutinib if you are a private patient through your insurance as your doctor doesn't have to abide by the NICE guidance.

[Dancedunce]

I just wanted to add my experience to this subject. After Obinutuzumab for a few months and ibrutinib for 22 months, I reached uMRD in BMB test but still had a few small lymph nodes lingering on a CT. I had to stop Ibrutinib because of side effects but after 10 months I am still in remission. I know everyone is different, but I am surprised by my results. I do hope that this is a option for others too. It is nice to have a break from therapy. Down side of Obinutuzumab right now is after 4 COVID-19 vaccines, I have still not formed antibodies.