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1733 Final Study Results of Newly Diagnosed Chronic Myeloid Leukemia Chronic Phase (CML-CP) Patients Receiving Radotinib 300 Mg BID or Imatinib: Rerise 48 Months Follow-up

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Therapy: Poster I
Hematology Disease Topics & Pathways:
Diseases, Biological, Adult, CML, Therapies, Study Population, Clinically relevant, Myeloid Malignancies, TKI
Saturday, December 1, 2018, 6:15 PM-8:15 PM
Hall GH (San Diego Convention Center)

Young Rok Do, PhD, MD1, Jae-Yong Kwak, MD, PhD2, Hawk Kim, MD, PhD3, Jeong-A Kim, MD, PhD4, Hyeoung-Joon Kim, MD, PhD5, Joon Seong Park, MD6*, Jooseop Chung, Doctor7, Ho-Jin Shin, MD, PhD8*, Sung-Hyun Kim, MD, PhD9, Udomsak Bunworasate, MD10*, Chul Won Choi, MD, PhD11*, Narcisa Sonia Cornejo Comia, MD12*, Dae Young Zang, MD, PhD13*, Sukjoong Oh, MD, PhD14, Saengsuree Jootar, MD15*, Ary Harryanto Reksodiputro, MD, PhD16*, Won-Sik Lee, MD17, Yeung-Chul Mun, MD, PhD18*, Jee Hyun Kong, MD19*, Priscilla B. Caguioa, MD20*, Jinny Park, MD, PhD21, Chul W. Jung, MD, PhD22 and Dong-Wook Kim, MD, PhD23

1Department of Internal Medicine, Dongsan Medical Center Keimyung University, Daegu, Korea, Republic of (South)
2Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea, Republic of (South)
3Division of Hematology, Ulsan University Hospital, College of Medicine, Incheon, South Korea
4Department of Hematology, The Catholic University of Korea, St. Vincent’s Hospital, Suwon, Korea, Republic of (South)
5Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea, Republic of (South)
6Ajou University School of Medicine, Suwon, Korea, Republic of (South)
7Department of Hematology-oncology, Pusan National University Hospital, Busan, Korea, Republic of (South)
8Department of Internal Medicine, Pusan National University Hospital, Busan, Korea, Republic of (South)
9Dong-A University Hospital, Busan, Korea, Republic of (South)
10Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand
11Divison of Hematology-Oncology, Department of Internal Medicine, Korea University College of Medicine, Guro Hospital, Seoul, Korea, Republic of (South)
12Mary Mediatrix Med. Ctr., Lipa City, PHL
13Department of Internal Medicine, Hallym University College of Medicine, Hallym University Hospital, Anyang, Korea, Republic of (South)
14Division of Hematology-Oncology, School of Medicine, Sungkyunkwan University, Kangbuk Samsung Hospital, Seoul, Korea, Republic of (South)
15Division of Hematology, Department of Internal Medicine, Ramathibodi Hospital, Bangkok, Thailand
16Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
17Inje Univ. Busan Baik-Hospital, Busan, Korea, Republic of (South)
18Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of (South)
19Division of Hematology-oncology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University College of Medicine, Wonju, Korea, Republic of (South)
20St. Luke's Medical Center Cancer Institute, Quezon City, PHL
21Division of Hematology, Gachon University Gil Medical Center, Incheon, Korea, Republic of (South)
22Samsung Medical Center, Seoul, KOR
23Department of Hematology, Seoul St. Mary's Hospital The Catholic University of Korea, Seoul, South Korea

Background: In RERISE phase 3 study, radotinib demonstrated significantly higher and faster rates of major molecular response (MMR) than imatinib in patients with newly diagnosed CML-CP. By 36 months follow up, MMR (BCR-ABL1IS ≤ 0.1%) and MR4.5 (BCR-ABL1IS ≤ 0.0032%) in radotinib 300 mg twice daily (bid) were higher than imatinib group. Also, early molecular response (EMR) at 3 months could predict better long term outcomes in both radotinib and imatinib groups. Here, authors updated 48 months long-term benefits and risks of 300mg bid and imatinib 400mg qd from RERISE phase 3 study (NCT01511289).

Methods: RERISE study was randomized trial of radotinib 300 mg bid (n=79), radotinib 400 mg bid (n=81), or imatinib 400 mg once daily (qd) (n=81) in patients with newly diagnosed CML-CP. We evaluated long-term MMR and MR4.5, overall survival (OS), and progression-free survival (PFS) including safety data by 48 months.

Results: At the study completion, 53% of patients with radotinib and 44% of patients with imatinib treated were remained. MMR and MR4.5 continued to be higher in patients receiving radotinib 300 mg bid compared with imatinib 400mg qd (Table). Especially, MMR rate by 48 months was significantly higher for radotinib compared to imatinib (76% vs 56%; P=0.0070, Figure). Also, early molecular response (EMR) at 3 months were observed in 86% of patients in the radotinib 300 mg bid group and 68% in the imatinib group (P = 0.0179). More patients treated with radotinib 300mg bid who had EMR at 3 months achieved MMR and MR4.5 by 48 months: 84% and 53% in the radotinib 300 mg bid group and 71% and 44% in the imatinib group, respectively. 48 months estimated OS and PFS rate were not significantly different in two groups (99% vs 94%; P=0.3224, 97% vs 94%; P=0.4328). Treatment failure was lower in radotinib group compared with imatinib group (Table).

The safety profiles were consistent with those previously reported and most of adverse events (AEs) developed within 12 months. No new or unexpected safety events were reported in both arms by 48 months and no serious CVE related with radotinib reported.

Conclusions: With a minimum 48 months follow-up, radotinib continued to demonstrate higher rates of MMR and MR4.5 than imatinib in newly diagnosed CML-CP. Also, these responses with radotinib were earlier and deeper compared with imatinib. Up to 48 months, no new and serious safety events related with radotinib reported. These results demonstrate that radotinib may have higher possibility of treatment- free remission (TFR) on frontline therapy as well as it can be one of the standards of care in newly diagnosed CML-CP.

Disclosures: Bunworasate: IL-YANG: Research Funding. Comia: IL-YANG: Research Funding. Mun: IL-YANG: Research Funding. Caguioa: IL-YANG: Research Funding. Kim: Pfizer: Research Funding; Novartis: Research Funding; BMS: Research Funding; Ilyang: Research Funding.

*signifies non-member of ASH