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Phase 1b results show manageable toxicities with Venclexta and Rydapt.
Vyxeos is a combination of two chemotherapy agents, daunorubicin and cytarabine, in a lipid carrier that is designed to home in on dividing the malignant, rapidly dividing myeloid cell that characterizes acute myeloid leukemia.
It makes for a more powerful chemotherapeutic agent: “As a result, you can deliver more drug to a cancer and less drug to the rest of the body and it creates a better safety profile,” says
Robert Iannone, M.D., executive vice president, research and development, chief medical officer at Jazz Pharmaceutical, the developer of Vyxeos.
Now researchers are testing with whether Vyxeos can be combined with other chemotherapy agents — a combination agent combined with other drugs. The three-arm, phase 1b V-FAST study is designed to test Vyxeos with three different drugs: Venclexta (venetoclax), a BCL-2 inhibitor; Rydapt (midostaurin), a FLT3-inhibitor; and Idhifa (ensaidenib), an IDH2 inhibitor.
Results from the V-FAST presented at the American Society of Clinical Oncology’s annual meeting this week show that patients can take the full doses of Venclexta and Rydapt with Vyxeos that is well tolerated, Iannone said in a video interview with Managed Healthcare Executive.® Enrollment in the “C arm” of the trial that involves Idhifa is ongoing.
Iannone says preliminary results from V-FAST also suggest the Vyxeos combinations are efficacious.