Radotinib May Yield Superior Outcomes to Imatinib in Newly Diagnosed Chronic Myeloid Leukemia
Researchers randomly assigned 241 patients to receive radotinib 300 mg twice daily, radotinib 400 mg twice daily, or imatinib 400 mg once daily.
|The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Radotinib yields earlier, deeper, and significantly higher major molecular response (MMR) rates in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) compared with imatinib, according to an oral presentation at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
In the open-label phase 3 RERISE study, researchers randomly assigned 241 patients to receive radotinib 300 mg twice daily, radotinib 400 mg twice daily, or imatinib 400 mg once daily. Analyses at 12 and 24 months showed that patients treated with radotinib twice daily achieved significantly higher and faster rates of MMR and MR4.5 compared with imatinib. Patients who had a complete cytogenic response after 12 months were followed for 3 years.
This 36-month analysis showed that patients in the radotinib 300 mg arm had a significantly higher MMR rate of 75% than the 54% MMR rate noted in the imatinib arm (P = .0076). The MR4.5 rate was also higher, at 43% vs 28% in the radotinib arm vs the imatinib arm, respectively (P = .0538).
The estimated 36-month overall survival (OS) rates were 98% and 97% in the radotinib arm and the imatinib arm (P = .0554), respectively, and the 36-month progression-free survival (PFS) rates were 99% vs 95%, respectively (P = .4707).
Fewer deaths and treatment failures occurred in the radotinib arm (6%) compared with the imatinib arm (17%) during the study, though this difference was insignificant.
The safety profiles were consistent with those previously reported: the most frequent adverse events (AEs) included rash, nausea/vomiting, fatigue, hyperbilirubinemia, pruritus, ALT elevation, and musculoskeletal pain. Grade 3 or worse AEs reported included hematologic AEs (eg, anemia, thrombocytopenia, neutropenia) and biochemical abnormalities.
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- Do YR, Kim H, Kwak JY, et al. Deeper molecular response in patients (pts) with newly diagnosed chronic myeloid leukemia chronic phase (CML-CP) patients receiving radotinib 300 mg BID or imatinib: Rerise 36 months follow-up. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.