Ibrutinib Plus Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia: Update on The CLARITY Study

[Jm954]

Published on line July 11, 2019, Accepted by JCO May 31 2019

Dr P Hillmen

We have some members who are in this important CLARITY Study in UK.

CLARITY is a phase II trial that combined ibrutinib with venetoclax in patients with relapsed or refractory CLL. The primary end point was eradication of MRD after 12 months of combined therapy.

In 53 patients after 12 months of ibrutinib plus venetoclax, MRD negativity (fewer than one CLL cell in 10,000 leukocytes) was achieved in the blood of 28 (53%) and the marrow of 19 (36%). Forty-seven patients (89%) responded, and 27 (51%) achieved a complete remission. After a median follow-up of 21.1 months, one patient progressed, and all patients were alive.

More here: ascopubs.org/doi/full/10.12...

Jackie

[cartwheels]

This is very encouraging news

[Newdawn Administrator]

These results always cheer me! 😊

Newdawn

[Jm954 Administrator in reply to Newdawn]

This is for R/R patients, should be much better for first line treatment

[J_88 in reply to Jm954]

Awesome

[J_88 in reply to J_88]

I was reading something where a trial had a 100% response rate, I can't remember what it was. I think it was Ibruitinib and FCR.

[Jm954 Administrator in reply to J_88]

Yep, I think that was first line.

[mrsjsmith in reply to Newdawn]

And me ! 🙂

[Fran57]

Great news!

Fran 😉

[HopeME]

If this combination is available and I realize that is a big if, is Ibrutinib and Ventetoclax now recognized as the best treatment for R/R CLL/SLL after having been treated with chemo? When might this combination be approved by the FDA entities in the various countries throughout the world?

Thanks

Mark

[Jm954 Administrator in reply to HopeME]

As far as I am aware this combination is only available in clinical trials at the moment and the data/results are too immature to determine what the long term results are like.

Once there is enough data showing clinical effectiveness and cost effectiveness then countries start to look at approving it by their regulatory bodies.

USA will probably be the first country in the world, they usually are.

Jackie

[HopeME]

It seems the data to support the combination’s adoption is rapidly accumulating. What is your best guess as to when it becomes available in the US? 2-3 years?

[DaleFL in reply to HopeME]

I was going to ask the same question. Can a phase II trial in the USA result in approval?

[Mldeterm in reply to DaleFL]

There are phase III combo trials running now, my husband is in one for treatment naïve. I think phase II just moves it along to phase III.

[pkpayne]

Inspiring!