With encouraging new research and literally hundreds of potential combination treatment options, a challenging question remains: which myeloma patients will respond best to specific drugs, in specific combinations, at specific times? Although researchers are working hard to answer these important questions, there is one subgroup of myeloma patients where a precision-based strategy may be possible. For the approximately 15% of patients who have translocation 11:14, t(11;14), it is believed that the potent oral, BCL2 inhibitor, Venetoclax may be an appropriate option to consider.
For information on the use of Venetoclax in myeloma patients with t(11:14), click here to listen to this HealthTree Podcast featuring Jonathan Kaufman from Emory University. (Note this is from October 23, 2020, but it is still relevant.)
At ASH 2022, two abstracts from Mohamed A Badawai, PhD and fellow authors provide useful insights regarding dose selection in relapsed t(11:14) patients:
- Abstract 1864: This analysis showed that patients receiving higher doses of Venetoclax alone or in combination with dexamethasone showed improved efficacy without an increase in adverse safety events compared to lower doses. “These findings support dosing Venetoclax at 800mg once a day dose in combination with dexamethasone in this patient population in the CANOVA Phase 3 study.”
- Abstract 3232: This analysis was designed to determine the optimal dose when Venetoclax is used in combination with daratumumab and dexamethasone. The authors state, “Exposure- response analyses support the selection and evaluation of the 400mg once a day dosing of Venetoclax in combination with daratumumab and dexamethasone in t(11:14)…” They note this is a lower dose than when Venetoclax is used as a single agent with dexamethasone.
What are My Myeloma Genetics?
As a myeloma patient, you may be asking, how do I know if I have t(11:14)? For most patients, if you have had a bone marrow biopsy, you can check your FISH report to find out if you are positive for t(11:14) or you can simply ask your doctor. Translocation 11:14 is not considered a high-risk genetic feature, but since there is a unique treatment option for these patients, it is useful to know your status. If you are in this subgroup, ask your doctor if at some point, Venetoclax may be an appropriate part of your treatment strategy.
If it is determined that Venetoclax may be right for you, there are a couple ways to potentially gain access. First, you can explore clinical trial options. There are numerous clinical trials currently recruiting t(11:14) patients at US and international sites. These trials can be found through HealthTree’s clinical trial finderor on the US government site.
Venetoclax in Other Cancers and Use in Myeloma
Venetoclax is FDA approved and available for Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL) patients. Although it is currently not FDA approved for myeloma, it is under investigation and appropriate patients may gain access by working with your doctor to submit a prior authorization.
Prior authorization approval is often based on a drug’s status on the National Comprehensive Cancer Network (NCCN) Guidelines for Myeloma. In Version 2.2023 released 10/31/2022, Venetoclax in combination with dexamethasone for t(11:14) patients is recommended in a list of options considered as “Useful in Certain Circumstances for Early Relapses (1-3 prior therapies).”
A Reason for Hope
The exciting research presented at ASH 2022 provides many additional reasons for hope! To turn hope into reality, myeloma patients are encouraged to get educated on the basics of myeloma including your overall genetic risk profile (standard or high) and t(11:14) status. With this education, we can be empowered to advocate for timely access to the best, most appropriate drugs, in the right combination, at the right time.
As a volunteer HealthTree Coach, Todd shares his time, knowledge of myeloma treatment and resources to help empower others to advocate for themselves.
about the author
Todd Kennedy was diagnosed with multiple myeloma in December 2017 and is grateful to be celebrating his deep remission and 5-year survivor milestone. His background includes over 30 years working in the pharmaceutical industry until he decided to refocus and serve as a patient advocate, research advisor, HealthTree Myeloma Coach and support group co-leader.