Rain Therapeutics announces completion of enrollment in phase III MANTRA trial for milademetan in liposarcoma.

The trial targeted an enrollment of 160 patients and completed enrollment five months ahead of schedule with 175 patients. The MANTRA trial is evaluating milademetan compared to an approved standard of care in patients with well-differentiated / dedifferentiated (WD/DD) liposarcoma (LPS) that have progressed on at least one prior systemic therapy including an anthracycline. MANTRA is an event-driven trial with progression-free survival (PFS) as the primary endpoint, which will be analyzed upon reaching 105 events. The MANTRA trial is powered to show a doubling of PFS versus the standard of care.

About MANTRA Trial :The MANTRA trial, a randomized, multicenter, open-label, Phase III registrational study, is designed to evaluate the safety and efficacy of milademetan compared to trabectedin, a current standard of care, in patients with unresectable or metastatic DD LPS with or without a WD LPS component that has progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. 175 patients were enrolled and randomized in a 1:1 ratio to receive milademetan or trabectedin. The primary objective of the trial is to compare progression-free survival (PFS) by blinded independent review between the milademetan treatment arm and the trabectedin control arm. Secondary endpoints include overall survival, PFS by investigator assessment, objective response rate, duration of response, disease control rate, safety and patient reported outcomes.