Study shows promise for Venclexta in acute myelogenous leukaemia
pharmafile | August 12, 2016 | News story | Research and Development, Sales and Marketing | AbbVie, Genentech, Roche, Venclexta, venetoclax
A study published in Cancer Discovery, the journal of the American Association for Cancer Research, suggests that Vencletxa (venetoclax) is safe and potentially efficacious in patients with acute myelogenous leukaemia.
The drug, which was approved by the US FDA in patients with chronic lymphocytic leukaemia in April, is co-marketed by AbbVie and Roche subsidiary Genentech in the US, while AbbVie retains the rights in the rest of the world.
Venclexta works by binding to BCL-2, an antiapoptotic protein that plays a role in many blood cancers. This then frees the propaptotic proteins, which rapidly and irreversibly induces the acute myelogenous leukaemia cells to undergo apoptosis, or cell death.
Although only a small study, researchers from Harvard Medical School, the Dana-Farber Cancer Institute and the University of Texas MD Anderson Cancer Center observed an overall response in 19% of patients, with two out of 32 patients having complete response to therapy. The researchers found that response to therapy correlated with the biomarker results of participants, including indices of BCL-2 protein expression and BH3 profiling.
Anthony Letai, senior author of the study, says: “Acute myelogenous leukaemia is a disease in which new therapies are desperately needed, and based on published preclinical work, this type of cancer seemed to be an excellent target for the BCL-2 inhibitor venetoclax. In this clinical trial, we found that even among pretreated patients whose AML was refractory to intensive chemotherapy there was evidence of exceptional sensitivity to selective BCL-2 inhibition, even to the point of complete remissions.
“It is also worth noting that in this age of precision medicine, dominated by genomics, this is an example of the importance of functional precision medicine. Chronic lympocytic leukaemia and acute myelogenous leukaemia lack genetic abnormalities related to BCL-2. Instead, their vulnerability to BCL-2 inhibition was identified using functional studies. This is support that functional studies need to be part of any mature precision medicine project.”
His colleague, lead author Marina Konopleva, adds: “We believe that venetoclax will soon become an equal partner to standard-of-care chemotherapy in elderly patients with acute myelogenous leukaemia when used in combinations with hypomethylating agents and other approaches. Planned studies will test the hypothesis that venetoclax may likewise improve outcomes in younger acute myelogenous leukaemia patients when combined high dose chemotherapy.”
The study was funded by AbbVie in collaboration with Roche.
Sean Murray
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