Hanmi Pharm(Hanmi) announced on the 11th that additional clinical data on its new drug ‘Tuspetinib (TUS1)’ for the treatment of acute myeloid leukemia (AML), was presented at the American Society of Hematology (ASH) on the 9th.
Aptose, a partner company developing TUS, disclosed a detailed clinical profile related to the advanced clinical data of TUS at the ASH.
The published clinical profile shows that excellent effects, such as ‘complete response (disappearance of tumor),’ have been consistently confirmed in TUS monotherapy and combination therapy with other drugs (Venetoclax, VEN).
Dr. Naval G. Daver, an MD Anderson Cancer Center professor, said, “The effectiveness of TUS was excellent for AML both as a monotherapy and in combination with other drugs.”
Hanmi explained, “TUS showed sustained therapeutic effects even in patients who did not undergo hematopoietic stem cell transplantation (HSCT) treatment,” and added, “Clinical test results showed no side effects or toxicity at the maximum daily dose of TSU.” Accordingly, Hanmi decided the recommended dose for the future phase 2 to be 80mg.
TUS is an oral myeloid kinome inhibitor (MKI) administered once daily and targets key kinases that act in myeloid malignancies.
Previously, Hanmi signed a contract with Aptose to export TSU technology worth USD 420 million in 2021. The U.S. FDA designated TUS as a first-in-class drug (2018) and a fast-track development item (2022).
Dr. Dever explained, “TUS has shown therapeutic effects in relapsed/refractory AML, an incurable disease,” and added, “TUS is showing therapeutic effects in a broad group of patients with AML.”
He continued, “The safety profile of TUS serves as a basis for future use of TUS/VEN/HMA (Hypomethylating agent) triple therapy as a first-line treatment for new AML patients.” He added, “We expect that patients in the early stages of therapy will have an excellent drug response.”
The link to the Korean version of this article is as below.
▷한미약품, 급성골수성백혈병 신약→美 혈액학회서 단독·병용요법 효과 발표
By_BK Min, KDFN
kdf@kdfnews.com
Source_ⓒHanmi Pharm
