It announced the decision 10 months after it agreed to include an AML trial in its initiative to advance promising blood cancer research.
Those conducting the Beat AML Master Trial (NCT02927106) are using advanced genomic techniques to identify the mutations behind patients’ cancer. Then they assign the patients drugs that can address their mutation-driven cancer subtypes.
This means different patients receive different drugs — the reason why the approach is called precision medicine.
The study, which began in October 2016, is the first cancer trial led by a non-profit organization. The main question the trial seeks to answer is: “Can a personalized therapy based upon genomics be assigned to an AML patient within a seven-day period in a safe manner?”
AML treatment has changed little in 40 years. It consists of a combination of chemotherapies that many consider toxic.
Patients’ prognosis remains poor. Only 20 percent of those older than 60 live more than five years after treatment.
The Leukemia and Lymphoma Society invested more than $40 million in blood cancer research projects worldwide in 2016. The 75 newest grants mean it is now supporting 300 projects at leading scientific and medical centers. The work covers leukemia, lymphoma, myeloma, and other blood cancers.
Those conducting the Beat AML Master Trial said it takes only seven days to learn which mutations are behind a patient’s AML and match the person with a drug. That’s a lightning-fast time frame in genomic technology.
Seventy people have already enrolled in the trial, which is covering newly diagnosed patients age 60 and older.
Patients are receiving either samalizumab (ALXN6000), an anti-CD200 provided by Alexion; BI 836858, an anti-CD33 from Boehringer Ingelheim; enasidenib (AG-221/CC-90007), an IDH2 inhibitor from Celgene; or entospletinib, a SYK inhibitor from Gilead Sciences.
Three more pharmaceutical companies may join the trial soon. Eventually the study is expected to include 500 patients. Researchers expect it to continue another two years.
Six U.S. medical centers are participating in the study, including the Memorial Sloan Kettering Cancer Center in New York, the Ohio State University Comprehensive Cancer Center, and the Oregon Health & Science University Knight Cancer Institute. Four more centers are expected to join by September.
“Working closely with the U.S. Food and Drug Administration (FDA), renowned cancer researchers, medical centers and the pharmaceutical industry, we are seeking to change the way cancer research is conducted,” Dr. Louis J. DeGennaro, the president and chief executive officer of the Leukemia and Lymphoma Society, said in a press release. “We are very grateful to those patients who have enrolled in the Beat AML Master Trial.”
The knowledge and treatments “resulting from this innovative trial will help tackle these diseases by delivering the right drug to the right patient at the right time,” he added.
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