HUTCHMED Limited (HCM), a commercial-stage, biopharmaceutical company, and Innovent Biologics Inc. (IVBXF.OB), on Tuesday, announced the conditional regulatory approval of ELUNATE in combination with TYVYT for the treatment of advanced endometrial cancer in China.
The approval follows a priority review and Breakthrough Therapy Designation, supported by positive results from the FRUSICA-1 Phase II trial, which evaluated the combination of ELUNATE and TYVYT.
The trial showed a 35.6 percent objective response rate (ORR), an 88.5 percent disease control rate (DCR), median progression-free survival (PFS) of 9.5 months, and overall survival of 21.3 months. The combination also demonstrated rapid efficacy, with a median time to response of 1.6 months.
ELUNATE, discovered and developed in-house by HUTCHMED, and TYVYT, jointly developed by Innovent and Lilly in China, are already approved individually for various cancer indications.
HUTCHMED and Innovent are further advancing the ELUNATE and TYVYT combination into a Phase III confirmatory study in advanced endometrial cancer.
HCM closed Monday's trading at $17.36, up 2.42%, while IVBXF closed at $4.85, unchanged from the previous day's close.
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