Can Venclexta be used for Multiple Myeloma?
Although Venclexta is not FDA approved for use in Multiple Myeloma (MM), some research indicates that it may be promising for some MM patients who have failed at least one prior treatment, especially those with the genetic abnormality t(11;14) or with high levels of BCL-2. However, its use is not without controversy.
One major trial investigating the use of Venclexta for relapsed and refractory MM was halted early by the FDA due to safety concerns. The BELLINI clinical trial used a regimen of Venclexta plus bortezomib (a protease inhibitor) plus dexamethasone for 291 patients with MM. Unfortunately, interim results at an average of 17.9 months revealed 41/194 people (21.1%) assigned to the Venclexta combination regimen had died compared to only 11/97 (11.3%) of those assigned to placebo. This equated to an increase of approximately two-fold in the relative risk of death from Venclexta. The FDA halted the trial on March 6, 2019; however, patients who were experiencing a clinical benefit could elect to continue if they wanted to. The FDA also suspended enrolment in other MM trials involving Venclexta that were ongoing at the time.
However, when researchers performed a subgroup analysis of the MM patients who experienced a clinical benefit, they found two subgroups of patients, those with the t(11;14) translocation and those with high levels of BCL-2, lived significantly longer without disease progression and there was also a non-significant trend towards longer survival.
Translocation is a genetic alteration that is common in MM patients. During translocations, chromosome segments and their genes change positions within the same chromosome or into another chromosome. The t(11;14) translocation means there is a translocation between chromosome 11 and chromosome 14.
Subgroup analysis of people with the t(11;14) translocation or high levels of BCL-2 revealed that 74% had a reduction in their risk of disease progression or death compared to placebo, higher response rates (88% vs. 70%), higher rates of complete response or better (42% vs. 3%), and higher rates of minimal residual disease negativity (19% vs. 0%), as well as a trend toward longer survival.
These findings do support the use of Venclexta in combination with other treatments for relapsed or refractory multiple myeloma bearing the t(11;14) translocation or with high levels of BCL-2. Other trials are currently ongoing.
Related questions
References
- Venclexta-Darzalex Combos Show Strong Response Rates in Multiple Myeloma Trial, Early Data Show. Dec 4 2019. Myeloma Research News https://myelomaresearchnews.com/2019/12/04/venclexta-darzalex-combos-showing-strong-response-rates-in-advanced-multiple-myeloma-trial/
- Inacio P. Venclexta Safe and Effective for Certain Multiple Myeloma Patients, Trial Data Show. Dec 3, 2019. Multiple Myeloma News https://myelomaresearchnews.com/2019/12/03/venclexta-safe-effective-in-subset-relapsed-refractory-myeloma-patients-data-show/#:~:text=Venclexta%20(venetoclax)%2C%20approved%20to,data%20from%20two%20studies%20suggest.
- FDA Warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma [3/21/2019] U.S. Food and Drug Administration https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-risks-associated-investigational-use-venclexta-multiple-myeloma
Read next
How is Venclexta (venetoclax) used for AML?
Venclexta is given once-daily with food in combination with either azacytidine, decitabine, or low-dose cytarabine in adults with AML. It works by binding to a specific protein that is over-expressed in cancerous lymphocytes, killing them. Continue reading
How does Venclexta work?
Vencelxta works by binding directly to a protein called BCL-2, which is overexpressed on some cancer cells. When Vencelxta binds to BCL-2 it displaces other proteins, such as BIM, which help to activate the process of apoptosis, which leads to the death of the cells. Continue reading
Is Velcade a type of chemotherapy?
Velcade is not a traditional form of chemotherapy (chemo). Velcade is a targeted drug therapy in the class of drugs known as proteasome inhibitors. Continue reading
Related medical questions
- Can Darzalex cure Multiple Myeloma?
- How long does Velcade stay in your body?
- Is Kyprolis a chemo drug and how does it work?
- How effective is Velcade for multiple myeloma?
- What is the mechanism of action for Tecvayli (teclistamab-cqyv)?
- Is Tecvayli FDA approved as a multiple myeloma treatment?
- What’s the difference between Tecvayli and Talvey?
- Is Darzalex chemotherapy?
- Where can I find the Tecvayli FDA package insert?
- How is Kyprolis (carfilzomib) administered?
- What is the success rate for Carvykti?
- What is Empliciti (elotuzumab)? and how does Empliciti work?
- What’s the mechanism of action of Carvykti?
- Is Abecma an orphan drug?
- What is Ninlaro used for?
Drug information
Related support groups
- Venclexta (6 questions, 3 members)
- Venetoclax (6 questions, 7 members)
- Multiple Myeloma (20 questions, 52 members)