Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE):
More evidence of Ibrutinib superiority.
I think ibrutinib is great and I am sure the guys that design these studies know more than me, but I don’t get why the comparator drug in these studies is so often chlorambucil. Maybe it’s the pharma company playing it safe to “win” the trial.
The studies that compare the new kids on the block to FCR, BR or even among themselves provide so much more informaation to us. Every new drug should be able to outperform chlorambucil, this trial was a gimme going in.
The ibrutinib/FCR trial was very helpful. Now we want to see how all the new combos stack up. Let’s see how ibrutinib/Gazyva does vs venetoclax or venetoclax/Gazyva or ibrutinib/venetoclax. My guess is ibrutinib/venetoclax wins most all matchups. If Ibrutinib/rituximab beats FCR, imagine how much better ibrutinib/venetoclax would do.
Just stop using chlorambucil in these studies. It’s not helpful and seems designed to protect your drug. It’s like building a Ferrari and then testing it against a 20 yr old station wagon to see who wins. Try racing a Porsche if you really want to know if you are the fastest.
CajunJeff ... you're in auspicious company. I just heard Dr. Jeff Sharman (Medical Oncologist, Willamette Valley Cancer Institute and Research Center; Medical Director, The US Oncology Network) say that he thought the study testing Chorambucil against Ibrutinib was 'verging on unethical' because it was so well understood prior to the initiation of the head-to-head, that chlorambucil would lose.
Source: 6:04 into the 'Daily Wrapup, Day 5', 5th December, 2018 of the PatientPower ASH daily reviews.
In the UK Nice expect trials of new treatments to be compared with the best available which is why so many struggle to get approval and then there is the cost. Likely combinations will increase the chance of long term remission so may be cost effective.
This has been an issue for a long time. Why chlorambucil vs chlorambucil and Gazyva, for example? Obvious answer, and many doctors in the US leave the chlorambucil out now. Sadly that isn’t an option for patients in many countries. I agree with Dr. Sharman.
I was on the iLLUMINATE trial and got the chlorambucil/obinutuzumab arm. I have 17p and it wasn't very effective. My nodes reduced by only 20 per cent and my lymphocyte count was never lower than 11,000 after six months. A month after my treatment ended my lymphocytes had rebounded to 50,000 and I needed to be treated again. The lure of the trial was free access to Ibrutinib thereafter but as it turned out my haematologist had a Zanuibrutinib trial starting and I was enrolled in that instead (partly because I have stents and Z interferes less with platelets). Three years later, the drug is still working and my lymphocyte count is normal for the first time since 2010. (No one knows why my lymphocytes took nearly three years to reach normal since blood is usually cleared very quickly with 17p, but it is viewed as a good sign.)
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