Revolutionary results in the treatment of acute myeloid leukemia patients

An exceptional abstract was presented during the virtual 25th European Hematology
Association (EHA) Annual Congress (June 11-21). The abstract demonstrated revolutionary
outcomes in treating patients with acute myeloid leukemia (AML), who have very few
therapeutic options.
The results constitute a historical breakthrough after 20 years in which many attempts have
been made to develop a therapy for AML patients who are ineligible for bone marrow transplant.
or intensive chemotherapy. The breakthrough has shown these patients can now receive a
relatively simple oral treatment that extends their survival. This patient group is characterized
by extremely low survival prospects (less than 10% for five years). AML is the most common
type of acute leukemia, with 160 thousand patients who live with the disease across the globe.
Phase III of the trial showed that the survival rate of patients ineligible for intensive
chemotherapy, who were treated with combo-therapy of Venetoclax and Azacitidine, rose
significantly compared with the control arm, which received Azacitidine and placebo, with a
complete response (CR) of over X2. The patients who received the combo-therapy with
Venetocalx achieved a 34%-decrease in the risk of death as well as a median survival of five
months. None of previous phase-III trials demonstrated survival rate superiority with focused
treatment in this type of leukemia.
Israel was the fifth largest country in terms of the number of patients enrolled in the study. It
was also one of the first countries in the world to approve the therapy and include it in the
National Health Basket based on earlier findings from phase-Ib. The approval was granted as
part of a pilot track, which accelerates the registration of selected therapies that respond to a
significant unmet need.
Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and
Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
Dr. Courtney D. DiNardo from the department of leukemia at the MD Anderson Medical
Center, and the chief researcher in the study: "Patients who are diagnosed with AML face a
very difficult disease with few currently approved treatment options, and survival in this patient
population is low. Patients and their healthcare providers need access to treatments that have
demonstrated both safety and efficacy in well-designed clinical trials. Given the seriousness and
aggressiveness of this AML, I’m hopeful regulatory agencies will work closely with the trial
sponsors to determine a pathway to provide. I have enjoyed close collaborations with Israeli
physicians and in particular was fortunate to attend a Hematology Conference in Tel Aviv in
early 2019. Since that time, I have remained in close contact with several Israeli physicians, and
we have shared wisdom on patient experiences with venetoclax-based therapies".
Irene, 84, from Lod, was diagnosed with acute myeloid leukemia in February 2019: “They
referred me immediately to a series of tests. At the time of diagnosis, I felt perfectly well. I was
active, athletic and strong, so it came as a devastating shock. I had no choice but to fight back,

which I did, with the invaluable help of my daughter, who has been extremely supportive. I have
no words to describe the suffering that came with therapy. Then my doctor, Dr. Arieh Appel
from Assaf Harofe Medical Center, told me about the new therapy, describing it as a rescue. I
regained my hope, and he was right. I am a new woman today. I am my old self again. I grew
stronger and gained weight, and my functioning is normal. I’m excited about the Health Ministry
adding the therapy to the basket so that other patients and I can benefit from it.”