Long-term Efficacy and Safety Proven
Il-yang Pharmaceuticals announced on Dec. 4 that it introduced the long-term efficacy and safety of its leukemia treatment ‘Supect’ (ingredient name: radotinib) at the American Society of Hematology (ASH) held in San Diego, USA from Dec. 1-4.
Professor Do Young-rok of the Department of Hemato-oncology at Keimyung University presented the outcome of a 48 month-long phase 3 clinical trial on patients diagnosed with chronic myelogenous leukemia.
In the 48-month clinical trial conducted by Professor Do, 76% of patients who were treated with 300 mg of radotinib twice a day for at least 48 months achieved major genetic responses (MMR, BCR-ABL1 ≤ 0.1%). This number was more statistically significant than the result previously received from treating patients with 400 mg of imatinib once a day (56%, P = 0.0070).
Any new serious adverse reactions were not found in the long-term treatment up to 48 months, and any adverse reaction that is found to be problematic for long-term safety in other second-generation drugs have not been reported.
In particular, radotinib’s clinical results for deep molecular response (MR4.5, BCR-ABL1 ≤ 0.0032%), which assesses the possibility of discontinuing medication in patients with chronic myelogenous leukemia, also appeared to be higher than that of imatinib, which received 33% respectively.
MR4.5 refers to a case in which the oncogene for leukemia is “less than 0.0032%” and is not detected in the test. If such a response is maintained for a certain period of time after reaching MR4.5, there is a possibility of a concept called “functional cure,” which refers to a state in which a stable condition is maintained without a recurrence after the drug treatment for chronic myeloid leukemia is ceased.
In addition, the number of patients who discontinued the clinical trials before reaching 48 months due to treatment failures was found to be significantly smaller than that of the group treated with imatinib when analyzed statistically.
Meanwhile, the long-term follow-up results were also announced at the Asia CML Study Alliance (ACSA) meeting held on December 2 by CML experts from Asia.