COLUMBUS, Ohio – Patients participating in the Leukemia & Lymphoma Society’s (LLS) precision medicine Beat AML Master Clinical Trial had superior treatment and survival outcomes compared to acute myeloid leukemia (AML) patients who opted for standard chemotherapy treatment, according to findings published today in the medical journal Nature Medicine. The Beat AML trial was launched in 2016 as a research collaboration between top leukemia researchers, biopharmaceutical companies and a leading genomics information company aimed at advancing treatment for AML, a deadly disease that affects more than 20,000 Americans annually but that has seen few treatment improvements in the past 40 years. In this new newly reported data, the Beat AML research team reports data demonstrating that genomic analysis of the leukemia cells to identify AML subtypes can be completed within seven days. “This is unprecedented and practice-changing because it gives us critical information to guide more personalized treatment decision without risking the patient’s chance for survival. In the past, this type of analysis simply wasn’t available or could take months, causing risky delays in treatment,” says John C. Byrd, MD, a hematologist and scientist with The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). Byrd serves as lead investigator of Beat AML trial and corresponding author of the Nature Medicine study. He is the D. Warren Brown Chair of Leukemia Research of The Ohio State University College of Medicine. Researchers note this new data demonstrates a paradigm shift in how patients diagnosed with AML should be treated, proving that using genetic information to match patients to targeted therapies leads to better survival rates than the traditional one-size-fits-all treatment approach. For decades, the standard of care for AML patients has involved either an infusion of a combination of two chemotherapies — cytarabine and daunorubicin ­­­— or treatment with a so-called hypomethylating agent, a drug that unleashes signals allowing the cancer cells to die. These therapies, however, have shown limited effectiveness for long-term cancer control. “The study shows that delaying treatment up to seven days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival compared to patients who opted for standard of care,” adds Byrd, “This patient-centric study shows that we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual case.” The Beat AML study is led in partnership by Byrd; Amy Burd, PhD, LLS vice president of research strategy, and first author on the paper; and Brian Druker, MD, director of the Knight Cancer Institute at Oregon Health & Science University, and Ross L. Levine, MD, director of the Center for Hematologic Malignancies at Memorial Sloane Kettering Cancer Center. To date, the trial, which is ongoing, has screened more than 1,000 patients at 16 cancer centers. The data presented in today’s Nature Medicine publication represents patient enrollment during a slice of time between November 17, 2016 and January 30, 2018. Compelling Data Findings Of 487 patients with suspected AML who agreed to participate during that timeframe, 395 were found eligible for the trial. Screening and analysis was successfully completed within the seven-day timeline for 374 (94.7 percent) of those patients. Ultimately, 224 of those patients opted to participate on one of the 11 study arms that were active during that period. The patients who chose not to join the study either opted for standard of care, palliative care or an alternative clinical trial. The median overall survival for patients in Beat AML was 12.8 months v. 3.9 months for patients opting for standard of care. Alice Mims, MD, who serves as the principal investigator of the Beat AML study arm at the OSUCCC – James, notes that since 2017, five new agents have been approved for newly diagnosed AML patients — either as single agents or in combination with other chemotherapy drugs ­— but none are considered curative, especially in older patients (age greater than 60). “The Beat AML has shown us that waiting on sequencing results to return in newly diagnosed, older patients is safe to do for the majority of patients and can be helpful in selecting initial, upfront therapy. This individualized approach to therapy ensures the patient gets the right therapy at the right time. In the past, AML was treated with a blanket approach where all patients received similar therapies and resulting in overall poor long-term outcomes,” says Mims. “This benchmark study is already advancing our scientific understanding of this disease and new potential options for treatment through clinical trials that will hopefully yield benefits for both young and older AML patients through better, less toxic treatment approaches that offer curative intent.” To learn more about ongoing hematology research and patient care at the OSUCCC – James, visit cancer.osu.edu/hematology or call 1-800-293-5066. OSUCCC – James Media Contact: Amanda J. Harper Direct Line: 614-685-5420 Central Media Relations: 614-293-3737 Amanda.Harper2@osumc.edu LLS Media Contact: Andrea Greif 914-772-3027 andrea.greif@lls.org