Dr. Matt Davids from Dana Farber presents early but very promising data on the combination of two strong oral targeted therapies, ibrutinib and venetoclax as front line therapy in CLL (chronic lymphocytic leukemia).
The CAPTIVATE trial was presented at the huge ASCO (American Society of Clinical Oncology) Annual Meeting 2018.
- Treatment-naïve patients <70 years old who needed treatment first receive single-agent ibrutinib for 3 months before initiating the venetoclax ramp-up to 400 mg/day.
- No clinical tumor lysis syndrome (TLS) occurred with the ibrutinib lead in. TLS occurs when cancer cells are killed so quickly they overcome the body’s ability to cope. Starting ibrutinib first significantly the risk that has been a serious problem with venetoclax in the past, largely mitigated by a slow ramp up in dosing.
- Side effects included diarrhea (39%), fatigue (23%), nausea (23%) and arthralgia (21%); significantly low neutrophils were seen in 10%. This is what might be expected with these drugs taken individually
- Response was seen 100%, in all 14/14.
- CLL was undetectable (U- MRD or undetectable minimal residual disease) down to 1 in 10,000 cells in the peripheral blood in the 9/11 assessed patients.
This is very small and early data. Longer follow-up and larger numbers will be presented at ASH 2018, but this was the first encouraging news and was presented at ASCO in Chicago where more research on chronic lymphocytic leukemia is no being debut.
This trial is exciting for three important reasons:
- It is a non-chemo approach in CLL using two strong oral targeted therapies that quickly knocked down the CLL to below detectible levels in most patients.
- It is using MRD status to guide therapeutic decisions.
- It is assessing stopping therapy after a fixed duration in this non-chemo approach.
Stay tune for an update from ASH soon.
Here is a link to the ASCO abstract:
Here is my five minute interview with Dr. Matt Davids:
Thanks for your interest.
We are all in this together
Executive VP and Chief Medical Officer, CLL Society