Dr. Gasparetto on Safety Concerns With Venetoclax in Multiple Myeloma

Cristina Gasparetto, MD
Published: Wednesday, Jul 17, 2019



Cristina Gasparetto, MD, an associate professor of medicine and director, Multiple Myeloma Program at Duke Cancer Institute, discusses safety concerns with venetoclax (Venclexta) in multiple myeloma.

Venetoclax targets the t(11;14) population, which accounts for about 30% of all patients with myeloma, says Gasparetto. Responses are generally very high in this patient population. When combined with dexamethasone, responses were about 60%. When venetoclax is combined with carfilzomib (Kyprolis), responses are nearly 100%. However, there is some concern with the increased risk of infection. As such, all patients are receiving antibiotics and prophylaxis.

In the phase III BELLINI study, patients in the relapsed setting were randomized to receive bortezomib (Velcade) and dexamethasone, which is a standard backbone, versus bortezomib, venetoclax, and dexamethasone. The primary endpoint was progression-free survival, which was found to be statistically significant. However, overall survival was inferior because there were an increased number of deaths in the experimental arm primarily due to bacterial infections, explains Gasparetto. In March 2019, the FDA suspended all clinical trials with venetoclax in multiple myeloma based on data from BELLINI, and a statement from the FDA regarding the agent’s future development is still pending.
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Cristina Gasparetto, MD, an associate professor of medicine and director, Multiple Myeloma Program at Duke Cancer Institute, discusses safety concerns with venetoclax (Venclexta) in multiple myeloma.

Venetoclax targets the t(11;14) population, which accounts for about 30% of all patients with myeloma, says Gasparetto. Responses are generally very high in this patient population. When combined with dexamethasone, responses were about 60%. When venetoclax is combined with carfilzomib (Kyprolis), responses are nearly 100%. However, there is some concern with the increased risk of infection. As such, all patients are receiving antibiotics and prophylaxis.

In the phase III BELLINI study, patients in the relapsed setting were randomized to receive bortezomib (Velcade) and dexamethasone, which is a standard backbone, versus bortezomib, venetoclax, and dexamethasone. The primary endpoint was progression-free survival, which was found to be statistically significant. However, overall survival was inferior because there were an increased number of deaths in the experimental arm primarily due to bacterial infections, explains Gasparetto. In March 2019, the FDA suspended all clinical trials with venetoclax in multiple myeloma based on data from BELLINI, and a statement from the FDA regarding the agent’s future development is still pending.

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