Venetoclax is FDA approved for use in certain types of leukemia. It proved to be useful for some leukemia patients with a chromosome 17 P deletion. For the past few years, Venetoclax has been the subject of several studies for use in myeloma. But it has been a bumpy road. During testing several patients died and the FDA, for a time, put a halt to the study. It is still unclear exactly why the deaths happened. But at the same time, studies have shown that Venetoclax has a remarkable ability to target myeloma cells in patients with chromosome 11/14 translocations without this kind of toxicity.
The FDA has not yet approved Venetoclax for use in myeloma. Some doctors are using it off label for their t (11;14) myeloma patients. Many are calling for its approval.
There were a number of abstracts dealing with Venetoclax at ASH 2019. Here is a summary of several of their conclusions.
This study recognized that the results of previous study and the shorter overall survival rate (due to the deaths) highlighted the challenges secondary resistance poses and the need to investigate the mechanisms mediating the emerged resistance to Venetoclax.
The study discovered mutations that cause resistance to Venetoclax. The conclusion states that early detection and dynamic monitoring of these abnormalities with early therapeutic interventions targeting these clones may enhance Venetoclax efficacy and improve patient survival.
It was an earlier BELLINI study that had the patient deaths. The study was halted but those who were benefiting from the drug were allowed to continue. This phase 3 study concludes: “ Adding Venetoclax to Bortezomib demonstrates significant efficacy in patients with relapsed refractory multiple myeloma harboring either T (11; 14) or tumor cells expressing high levels of BCL2. The benefit risk profile appears to be favorable in these subsets of patients and additional studies to gain further safety and efficacy information are warranted.”
This study showed that Venetoclax was efficacious and demonstrated tolerable safety in patients with T (11;14) relapsed refractory multiple myeloma. It’s stated that these results support further investigation Venetoclax combinations in this patient population.
Health related quality of life was comparable in patients receiving Venetoclax in combination with bortezomib and dexamethasone compared to patient receiving bortezomib and dexamethasone alone.
Thank you to our Myeloma Coach ASH 2019 sponsors:
By Vicki Jones
about the author
I’ve been fighting Multiple Myeloma for more than 15 years. I’ve been on pretty much every approved drug regimen and they’ve all worked really well for me. But of course nothing works forever. Other than some minor fatigue and some of the normal side effects of being 66, I’m feeling great! My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. I’ve recently retired from a career as a CPA. Being a Myeloma Coach is a new found joy.