12:00 AM
Oct 24, 2016
 |  BioCentury  |  Product Development

A new BEAT for AML

How LLS hopes to disrupt AML paradigms with new platform trial

With the first collaborative, multidrug trial in a blood cancer, The Leukemia & Lymphoma Society aims to dramatically alter the 40-year-old diagnosis and treatment paradigm in first-line acute myelogenous leukemia, and to create a virtuous cycle of identifying new driver mutations that can be matched to targeted agents.

The standard of care in first-line AML consists of four to six cycles of anthracycline-based chemotherapy plus cytarabine. The drugs are started together. Anthracycline is given for the first three days and cytarabine for a full seven days. The regimen, commonly called “seven plus three,” has been in use since the early 1970s.

Once patients are in remission, they undergo consolidation chemotherapy and may receive a stem cell transplant.

Genomic analysis is used for prognostic purposes and to identify candidates for stem cell transplants, but not to choose drug therapy given lack of approved targeted agents for newly diagnosed patients.

In the over-60 population, who constitute the majority of newly diagnosed patients with AML, many cannot tolerate the intense chemotherapy cycles, resulting in a five-year survival rate in this population of about 10%, according to LLS.

LLS hopes to change this.

“A one-size fits-all approach doesn’t work. So we are leading the offensive against AML using an innovative precision medicine protocol with genomic technology to find and match mutations in patients over age 60 with those drugs best-suited to attack their mutations,” said Louis DeGennaro, president and CEO of LLS.

The trial will begin enrolling up to 500 patients by December.

Patients will have a bone marrow biopsy that will be screened using Foundation Medicine Inc.’s genomic profiling assay for hematologic malignancies. Patients will be assigned to a treatment arm based on the genomic analysis.

The trial will start with four different treatment arms, including a “marker-negative” group for patients with a genomic profile that does not match a targeted agent.

“Everyone screened and enrolled in the trial will be given the opportunity to receive a treatment,” said John Byrd, who is co-PI on the study and chair of leukemia research and director of the division of hematology at The Ohio State University Wexner Medical Center.

Four biopharma companies will provide study drugs and financial support: Alexion Pharmaceuticals Inc., Boehringer Ingelheim GmbH, Celgene Corp. and Gilead Sciences Inc.


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