CANCER DIGEST – Aug. 12, 2016 – In a small trial with 32 patients with acute myelogenous leukemia (AML) that no longer responded to chemotherapy, four patients treated with a new drug achieved a complete response, meaning no sign of cancer, and six had no cancer cells present, but continued to have signs of the cancer in their blood.
That is enough of a response to the drug Venclexta (venetoclax) to give researchers hope of adding a new approach to treating acute myelogenous leukemia, a particularly deadly type of blood cancer in which only about 27 percent survive five years after diagnosis.
The oral drug, Venclexta made by Abbvie and Genentech, was FDA-approved in April for the treatment of chronic lymphocytic leukemia (CLL). It works by targeting a gene called BCL-2, which plays a key role in promoting cancer cell growth and is over produced in CLL patients.
In the AML study researchers at Dana Farber Cancer Institute in Boston and MD Anderson Cancer Center in Houston found that although AML is not known for having the BCL-2 mutation, some of them do, and those might benefit from the oral Venclexta. They found that six of the patients had indications of high BCL-2 mutations suggesting that by careful analysis of AML patients might show who might benefit from the drug.
In the study, 19 percent of the 32 patients responded to the drug, two had a complete response and four had complete response but with blood counts indicating the undetectable cancer was still present. The response lasted a median of 144 days, meaning the cancer was halted in half the patients who responded for less than 144 days and half responded for longer.
This duration of response was not a long as the researchers had expected. Still it offers a glimmer of hope for patients with this particularly intractable form of leukemia.
"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," senior author Anthony Letai, MD, PhD, associate professor of medicine at Harvard Medical School said in a press release.
"This could be accomplished by a single oral dose of venetoclax daily and demonstrated the potential clinical activity of BCL-2 inhibition in AML," he added.
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