UPDATE -- Rain Therapeutics Announces Completion of Enrollment in Phase 3 MANTRA Trial for Milademetan in Liposarcoma
– Phase 3 MANTRA trial completed enrollment five months ahead of previous guidance –
– MANTRA topline data anticipated in 1H 2023 –
– Management to host 2Q 2022 Earnings Call today at 5:00 PM Eastern Time –
NEWARK, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics, today announced completion of enrollment in its Phase 3 MANTRA randomized, global, registrational trial of its lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53. 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.
"We are excited to have achieved a milestone in our milademetan clinical program. We believe the rapid enrollment in MANTRA reflects a patient population in LPS that may be larger than expected, and that exhibits a significant unmet medical need,” said Avanish Vellanki, co-founder and chief executive officer of Rain.
Richard Bryce, MBChB, Rain’s chief medical officer continued, “The rapid enrollment five months ahead of schedule, across 70 international sites, also reflects the ability of the Rain team to expedite milademetan development for patients in significant need. Rain is grateful for the patients and clinicians who made the completion of enrollment in MANTRA possible, and we remain committed to the continued development of milademetan as a targeted therapy to reactivate p53 across a variety of MDM2-dependent cancers."
About MANTRA Trial
About Well-Differentiated/Dedifferentiated Liposarcoma (WD/DD LPS)
About Rain Therapeutics Inc.
Forward Looking Statements