Rain Therapeutics Initiates Phase 3 MANTRA Clinical Trial of Milademetan for De-differentiated Liposarcoma and Provides Patient Update from Prior Clinical Program
The randomized, multi-center, open-label Phase 3 trial will evaluate the efficacy and safety of milademetan in patients with de-differentiated (DD) liposarcoma (LPS)
Multiple patients with liposarcoma have demonstrated long-term therapy with milademetan monotherapy now exceeding 4 years
NEWARK, Calif., July 20, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc., a clinical-stage company developing precision oncology therapeutics, today announced that the first patient has been randomized in the multicenter, open-label, Phase 3 registrational study (MANTRA) evaluating milademetan (RAIN-32), an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of DD LPS.
“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. “We are proud to have advanced milademetan into a pivotal study less than 12 months after acquiring the program, and believe it has the potential to be the best-in-class MDM2 inhibitor.”
The MANTRA trial, a randomized, multicenter, open-label, Phase 3 registrational study, is designed to evaluate the safety and efficacy of RAIN-32 compared to trabectedin, a current standard of care, in patients with unresectable or metastatic DD LPS with or without a well-differentiated (WD) LPS component that has progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. Approximately 160 patients are expected to be 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.
The Company also provided an update on patients continuing to receive RAIN-32 monotherapy from the previously concluded Phase 1 dose escalation and expansion study. As of July 1, 2021, three WD/DD LPS patients received therapy with milademetan monotherapy for greater than 51 months. Two of these patients continue to receive therapy with durations now at 51 and 57 months without disease progression, and an additional patient received therapy for greater than 59 months beforediscontinuation in the second quarter of 2021. This highlights the potential for a favorable milademetan long-term tolerability and safety profile.
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