Kensuke Usuki, Toshihiro Miyamoto, Takuji Yamauchi, Kiyoshi Ando, Yoshiaki Ogawa, Masahiro Onozawa, Takahiro Yamauchi, Hitoshi Kiyoi, Akira Yokota, Takayuki Ikezoe, Yuna Katsuoka, Satoru Takada, Nobuyuki Aotsuka, Yasuyoshi Morita, Takayuki Ishikawa, Noboru Asada, Shuichi Ota, Atsushi Dohi, Kensaku Morimoto, Shunji Imai, Umi Kishimoto, Koichi Akashi, Yasushi Miyazaki
OBJECTIVES: NS-87/CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin. NS-87/CPX-351 exerts antileukemic action by maintaining a synergistic molar ratio of cytarabine to daunorubicin of 5:1 within the liposome while in circulation. Patients with high-risk acute myeloid leukemia (AML), which includes therapy-related AML and AML with myelodysplasia-related changes (AML-MRC), have poorer outcomes than those with other AML. METHODOLOGY: This open-label phase 1/2 (P1/2) study was conducted in 47 Japanese patients aged 60-75 years with newly diagnosed high-risk AML to evaluate the pharmacokinetics, safety, and efficacy of NS-87/CPX-351...
March 26, 2024: International Journal of Hematology