Early results of the Pirtobrutinib, Obinituzumab, Venetoclax trial I'm on have just been published

[SeymourB]

Dr. Jain of M.D. Anderson has published an oral abstract in advance of the European Hematological Association Congress June 13-16, 2024:

library.ehaweb.org/eha/2024...

Abstract: S164 Title: COMBINED PIRTOBRUTINIB, VENETOCLAX, AND OBINUTUZUMAB INFIRST-LINE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTICLEUKEMIA (CLL): A PHASE 2 TRIAL

The NCT info page:

clinicaltrials.gov/study/NC...

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

The trial is still recruiting.

The abstract does not mention that ClonoSEQ in peripheral blood was also done at end of Cycles 4 and 9, with similar U-MRD6 (<1 CLL cell in 1 million WBCs) results in the vast majority of patients, according to my trial nurse.

I was one of the first 7 participants, and finished in February, 2024. I have my first followup at the end of May, 2024. We'll be doing ClonoSEQ in peripheral blood again for each quarterly followup, I believe. I did have a single dominant clone detected in bone marrow out of 2.8M cells at end of Cycle 13. I consider that to be U-MRD6 even though it was not 0 detected dominant clones out of the whole sample. It was > 0 <1 out of 1 million.

I had a brief neutropenia. We stopped treatment briefly during cycle 11 in December, 2023 due to an unknown infection with fever > 100.4F/38C. Per the trial protocol, I was admitted to my local hospital, and did IV antibiotics and IVIG. I was discharged after the fever cleared, and then resumed trial meds.

=seymour=

[GumboKing]

way to go SeymourB

[scryer99]

That's a lot all at once, but it seems to be effective. Makes me glad I opted for combination therapy in a different clinical trial, even if it's taking longer than I had hoped.

[SeymourB in reply to scryer99]

scryer99 -

I do think that BTKi-BCL2 combos are the wave of the future for firstline treatment.

So I think the shorter duration of my trial compared to yours was enabled by the Obin. Did you have Obin in your trial?

So I'm very curious to hear more about your experiences on Zanubrutinib and Sonrotoclax - and anyone else on that therapy. There are 2 trials of that combo that I've found so far:

classic.clinicaltrials.gov/...

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

and:

classic.clinicaltrials.gov/...

Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

=seymour=

[scryer99 in reply to SeymourB]

I was an earlier wave, so no obinutuzumab for me. I've heard from two in the O arm and they both got to remission relatively quickly, less than a year. I've been in for a year and expect to be in for one more. I'm in that second trial. More details in my profile.

[SeymourB in reply to scryer99]

scryer99 -

I'll be curious to see your immune recovery, since Obin has a bad reputation for extended immune suppression.

=seymour=

[Poodle2 in reply to SeymourB]

Hi SeymourB, I was on O+V and I did have neutropenia for the whole duration of my treatment and needed regular GCSFs. My neutrophils were back to normal once I went off the GCSFs 4 weeks post treatment and stayed like that since. My immunoglobulins have been increasing and I have been really well - I have small kids and work as a primary school teacher so exposed to a lot of stuff! I am on prophylactic antibiotics but I'm genuinely shocked how healthy I have been since I stopped treatment - probably the best year in the last 10 years...I still can't believe it. I hope it lasts a few years at least.

All the best to you!!!

[Justasheet1 in reply to Poodle2]

Petra,

You went through hell asI remember. You will get more than a few years at least. The treatment you did is powerful.

Jeff

[Poodle2 in reply to Justasheet1]

Thanks Jeff 🙏🏻I pray and hope you are right. ❤️

[craterlake in reply to Poodle2]

Hi Poodle2 , that's so wonderful .. I am on O+V now .. very encouraging news . may God continue to bless you with a long remission .. James ...Romans 8:38-39

[Poodle2 in reply to craterlake]

Wishing you all the best Craterlake!

[cajunjeff]

Good stuff there Seymour, wishing you continued success.

[Zia2]

Triple? You’re brave! And thank you. Hope all continues well for you for a very long time.

[CoachVera55]

WOW, sounds like Rock Star Status. How did you tolerate it all 🤨🤔🧐

[CLLCalifornia-USA]

Stay strong Seymour. Thanks for sharing. Sally

[Stamphappy]

Seymour, thank you for participating in this trial and sharing this fantastic news! I'm grateful to hear you are doing well with this combo and pray for everyone's continued success. I'm really looking forward to your updates. Bless you.

[Smakwater]

Sounds like you're kicking butt Seymour!

Thanks for the update and trial participation.

JM

[bennevisplace]

Impressive results from the study so far. How are you feeling Seymour, compared with before treatment?

[SeymourB in reply to bennevisplace]

Bennevisplace -

I have lingering fatigue and sinus infection. Slowly working through the latter. Did a month of physical therapy to regain some strength. But I'm able to walk further than before or during treatment. The fatigue is no longer the profound must-sleep-now feeling.

=seymour=

[bennevisplace in reply to SeymourB]

I think that whatever the lab reports say, it takes the body quite a while to recover from a course of treatment. You had a whole year of it. I had 6 months of FCR and feel it has taken more than 3 years to get back into some kind of shape.