The University of Texas MD Anderson Cancer Center and Daiichi Sankyo said today they plan to develop novel therapies for acute myeloid leukemia (AML) through a multiyear collaboration whose value was not disclosed.

MD Anderson and Daiichi Sankyo said their collaboration will focus on carrying out “numerous” clinical trials assessing combination regimens that use several investigational compounds from Daiichi Sankyo’s pipeline and multiple other treatments.

The collaboration plans to launch multiple Phase I and Phase II clinical trials to be conducted by MD Anderson, with the aim of accelerating the development of new therapies. The studies will incorporate translational work, including exploration of novel biomarkers as well as preclinical studies of new agents targeting mechanisms of resistance to existing treatments, MD Anderson and Daiichi Sankyo said.

Among Daiichi Sankyo compounds to be studied will be quizartinib, a late-stage inhibitor against a receptor-type tyrosine kinase FMS-like tyrosine kinase-3 (FLT3). In October 2016, Daiichi Sankyo announced enrollment of its first patient in the global Phase III QuANTUM-First trial, designed to examine the safety and efficacy of quizartinib as a first-line treatment in combination with induction and consolidation chemotherapy and as maintenance monotherapy in patients with newly diagnosed FLT3-ITD-positive AML.

According to Daiichi Sankyo, approximately 30% of patients with AML have FLT3-ITD, a genetic mutation associated with more aggressive disease, resulting in increased relapse rate and reduced overall survival compared to those without the mutation.

Also to be studied by MD Anderson and Daiichi Sankyo are three of the company’s Phase I  AML candidates: DS-3032, a murine double minute 2 (MDM2) inhibitor under study in leukemia as well as solid tumors; DS-3201, a dual enhancer of zeste homolog 1 and 2 (EZH1/2) inhibitor being assessed for AML in the U.S. and non-Hodgkin's lymphoma in Japan; and PLX51107, a bromodomain and extra terminal protein (BET) inhibitor under study in blood cancers.

Also on the leukemia front, Daiichi Sankyo in January paid Kite Pharma $50 million upfront for Japanese rights to axicabtagene ciloleucel (formerly KTE-C19)—which a month earlier generated positive data in adult and pediatric relapsed/refractory acute lymphoblastic leukemia in Kite’s Phase I ZUMA-3 and ZUMA-4 trials.

AML is the most common type of acute leukemia, accounting for about 33% of all new cases of leukemia, according to Daiichi Sankyo.

“Given that AML is not a single disease, but a group of related diseases, it is important that we work to address it from a variety of angles,” Antoine Yver, M.D., evp and global head, oncology research and development at Daiichi Sankyo, said in a statement. “This illustrates the commitment of our AML franchise to science and academic partnership. By joining forces with the talent and resources of MD Anderson, we aim to help improve the standard of care for patients with AML.”

Added Hagop Kantarjian, M.D., chair of leukemia at MD Anderson: “It is our hope this collaboration will provide opportunities to offer more effective options for treating our AML patients.”








This site uses Akismet to reduce spam. Learn how your comment data is processed.