ASH 2022: Dr. John Allan on Outcomes for Chronic Lymphocytic Leukemia (CLL) Patients with Undetectable Measurable Residual Disease (MRD) After Treatment with Ibrutinib Plus Venetoclax
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The Bottom Line:
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who achieved undetectable measurable (or minimal) residual disease (uMRD) after fixed-duration ibrutinib + venetoclax treatment continue to have excellent outcomes four years after stopping initial therapy. The results of this study suggest that if patients achieve uMRD remission, it is safe to stop treatment.
Who Performed the Research and Where Was it Presented:
Dr. John Allan from Weill Cornell Medicine and colleagues presented the results at the American Society for Hematology Annual Meeting in 2022.
Background:
MRD measures how much disease is circulating in the blood or bone marrow. If your MRD test can’t detect any CLL cells, you have undetectable MRD (uMRD), which is excellent. We have more detailed information on MRD available here. Researchers are increasingly interested in using MRD status to guide treatment decisions (i.e., treat until reach uMRD), but clinical trial data is still needed to support this approach.
In this video, Dr. Deborah Stephens, a Director of the CLL program at the University of Utah Huntsman Cancer Institute, interviewed Dr. John Allan, a CLL specialist at Weill Cornell Medicine in New York City. They discussed recent results from the CAPTIVATE trial testing the combination of ibrutinib + venetoclax and MRD-guided discontinuation.
Methods and Participants:
The CAPTIVATE study is a phase II clinical trial of ibrutinib + venetoclax for patients ≤70 years of age who had not previously been treated for CLL. The study design is summarized in the figure below, and the cohort discussed in this interview is circled in red. After one year of treatment with ibrutinib + venetoclax, 86 patients had undetectable MRD and were randomized to ibrutinib-only treatment or placebo (43 in each group).
Results:
The CAPTIVATE trial has been going on long enough now that it has been about 3-4 years since patients stopped the initial ibrutinib + venetoclax therapy.
At three years, disease-free survival (meaning no measurable disease detected) was 85% in the placebo group and 93% in the ibrutinib group.
At four years, the progression-free survival (meaning the disease had not started growing again) was 88% in the placebo group and 95% in the ibrutinib group.
At four years, the overall survival (meaning how many patients are still alive) was 100% in the placebo group and 98% in the ibrutinib group.
These are great results for both groups. However, while ibrutinib may have a slight statistical progression-free advantage, it may not be meaningful considering the added side effects and costs of staying on therapy.
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Len
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“These are great results for both groups. However, while ibrutinib may have a slight statistical progression-free advantage, it may not be meaningful considering the added side effects and costs of staying on therapy.”
Also, the group who didn’t receive the Ibrutinib still has that drug as a future treatment, although most who received it and stopped prior to progression could use the ibrutinib again I suppose. This is so confusing. Hard to know what the best sequence of drugs is best for individual patients.
This is not a criticism, just a note about generics and brand names.
There is no such generic medicine - as of yet - named Ibrutinib. It's called and sold by its brand name Imbruvica by AbbVie.
... and there will not be any Ibrutinib until at least 2032 because AbbVie, Inc. spent over 1.2 Billion dollars in legal fees (and currently still spending) to make sure that they would keep their monopoly on the medicine until that time.
If anyone has the time, go to YouTube and check out US Rep. Katie Porter's questioning of the CEO of AbbVie. It'll probably help burn off some of those bastard white B cells.
SNIP: Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names.[1] Under the INN system, generic names for drugs are constructed out of affixes and stems that classify the drugs into useful categories while keeping related names distinguishable.[2] A marketed drug might also have a company code or compound code.[3]
A marketed drug has three names: a chemical name, a generic name, and a brand name. A chemical name is given when a new chemical entity (NCE) is developed. The chemical name is a scientific name based on the compound's chemical structure (e.g., 6-thioguanine) and is almost never used to identify the drug in a clinical or marketing situation. The generic name is granted by the USAN Council and is commonly used to identify a drug during its useful clinical lifetime. The company that patents the drug creates the brand name (trademark). This name identifies the drug during the 17 years that the company has exclusive rights to make, sell, and use it under patent law.
"I must differ with your interpretation / statements.
Ibrutinib is the generic or nonproprietary name of the drug and
Imbruvica is the trade or brand name of that drug. " ...
There is nothing to differ with. My statement: "There is no such generic medicine - as of yet - named Ibrutinib. It's called and sold by its brand name Imbruvica by AbbVie."
You cannot buy Ibrutinib (generic) anywhere until 2032 because AbbVie has been spending over a billion dollars to keep the generic off the market so they can sell their proprietary drug.
Abbvie put billions into R&D so they deserve the protection. Stop allowing a return on investment and the drug pipeline will dry up. I for one can’t afford the pipeline to dry up.
Katie Porter is an extremist. Just like Majorie Taylor Greene is an extremist on the other side of the aisle. I wish I could eliminate 10% of the politicians on the far left and 10% of the politicians on the far right. We would be a far better country if that were possible.
As far as AbbVie putting "billions into R&D": In 2015, AbbVie acquired Imbruvica through a 20.2 billion dollar acquisition of Pharmacyclics. That's not "R&D". And, then, they doubled the price without any improvements to the drug.
And regarding Rep. Katie Porter, there are videos of her questioning pharmaceutical executives.
This link is the video of her questioning the CEO of AbbVie. If this is radicalism, it is radical only for those who wish to gouge the sick and dying.
This isn’t the proper venue for this topic. I apologize for responding in the first place. I refuse to listen to this lady. I’ve heard enough of her nonsense in the past.
Mark and SurviveOr , with respect to your discussion, we have the book "For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug" where the finance writer Nathan Vardi, covers how ibrutinib and acalabrutinib revolutionised the treatment of CLL. On 13th April 2023, CLL Society published a book review by "Dr. Ed Ratner (who) is a physician, former entrepreneur, and CLL patient who wrote a review from his unique perspective on this book that chronicles the development of two blockbuster drugs that have revolutionized the care of CLL/SLL and made fortunes for early investors.
Dr. Ratner comments on the thorny questions raised by the book around drug costs and the often underappreciated role of patients or physician researchers in drug development." (my emphasis) cllsociety.org/2023/04/dr-e...
That review includes a link to An Interview With the Author About the Development of Ibrutinib and Acalabrutinib - by Dr Brian Koffman
There's also an excerpt from the book about the pivotal Pharmacyclics study results on two CLL patients for the drug which eventually became known as ibrutinib here: cllsociety.org/2023/04/exce...
The author, Nathan Vardi, shares 5 key insights into the process of the development of ibrutinib and acalabrutinib from his book here: nextbigideaclub.com/magazin...
Finally, with respect to CLL specific R&D by Abbvie, the ClinicalTrials.gov site lists 51 trials: clinicaltrials.gov/ct2/resu...
So, not only do you have an unparalleled insight into how new drugs become available, you both reside in a democracy where you can vote to improve the process. I appreciate you keeping political discussion out of the forum.
And further, when speaking of the "generic or nonproprietary name", it's not to be capitalized unless it's the first word of a sentence. Patented, brand names *are* capitalized to make it clear one is speaking about the specific brand name drug. So it's never "Ibrutinib" it's "ibrutinib". "Ibrutinib" with a capital "i" only occurs if it happens to be the first word of a sentece, since that is grammatically correct for all English words starting sentences. Thus regardless of where in a sentence it is, we say Imbruvica or Venclexta because theose are patented, brand names, but it would be incorrect to write "Venetoclax" in the middle or end. Just like in cardiac publications there is a lot of mention of "digoxin" but when someone writes"Lanoxin" it's that specific company's brand, not a generic made by any number of makers of digoxin.
Thus, the CLL Society website and other publications are correct when writing about "ibrutinib" and "venetoclax". They aren't writing "Ibrutinib" or "Venetoclax."
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Good end to a bad year... My MRD Results are in!
