All four adults with hard-to-treat acute myeloid leukemia (AML) who received treatment with a combination of Venclexta (venetoclax) and AB Science‘s experimental therapy AB8939 have responded to treatment, according to an update from AB.
The company previously announced that the first three participants in the AB18001 Phase 1/2 (NCT05211570) had all responded to the treatment, meaning their cancer burden was reduced to some extent.
A fourth patient has now responded, AB said in a company press release. The patient was in his fourth line of treatment, and his cancer carried a complex karyotype and TP53 mutation, molecular features that are associated with more aggressive disease and poorer response to available treatments, the company said.
AB said the patient had a “near complete response” after two weeks of treatment with AB8939 plus Venclexta. Two patients had partial responses (meaning the cancer burden decreased, but the cancer is still there), and one patient’s cancer is in full remission (showing no signs of active disease), according to the company.
“This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia,” said Nicholas J. Short, MD, associate professor and co-lead of developmental therapeutics in the leukemia department at the MD Anderson Cancer Center in Texas. “These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML.”
Study still recruiting patients
The treatment combination has been tolerated well so far, AB said. The company said there have been no safety issues suggesting the dose being used is too high, and no blood toxicity, which is a common issue with blood cancer treatments.
The Phase 1/2 study is currently recruiting participants at sites in Spain and Greece, with plans to expand recruitment to locations in the U.S. and France.
AML is an aggressive form of blood cancer. Venclexta is an approved AML treatment that works by triggering apoptosis (programmed cell death) in cancer cells by blocking signals that prevent this process. AB8939 is an experimental therapy that works by interfering with the molecular machinery that cancer cells need to divide, which is also expected to promote apoptosis.
“There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions,” said Olivier Hermine, MD, president of AB Science’s scientific committee and member of the Académie des Sciences in France. Hermine said the early clinical results “are supportive of this rationale.”
AB said the next step is to complete the Phase 1 trial and launch an expansion study in about 15 AML patients receiving the combination treatment at a selected dose. This phase is expected to provide early evidence of efficacy to support the clinical development strategy and potential partnerships.
At the same time, the company is discussing several registration options with the Food and Drug Administration and the European Medicines Agency, including the use of the combination as a first-line or later-line treatment, particularly in high-risk patients, or the use of AB8939 alone as a later-line treatment in patients with complex karyotypes.
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