Milademetan Introduced for Patients With De-Differentiated Liposarcoma in Clinical Trial
A phase 3 clinical trial has begun to evaluate the efficacy and safety of milademetan in patients with de-differentiated liposarcoma.
A phase 3 trial to evaluate the efficacy and safety of milademetan (RAIN-32) began in late July, after Rain Therapeutics, Inc. announced the first patient with de-differentiated liposarcoma (DD LPS) had been treated in the MANTRA trial.
“The start of our Phase 3 MANTRA study evaluating milademetan marks an important step forward in addressing a high unmet need for patients with DD LPS,” said Richard Bryce, MBChB, Chief Medical Officer at Rain Therapeutics, in a release.
Milademetan is an oral mouse double minute 2 (MDM2) inhibitor that demonstrated antitumor activity in a previous phase 1 trial. In the phase 3 trial, it will be compared with the current standard-of-care treatment, Yondelis (trabectedin).
The treatment will be given to 160 patients with unresectable or metastatic DD LPS with or without a well-differentiated LPS component that has progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. Researchers will examine survival outcomes and response rates as well as safety profiles.
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