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Rain Oncology Announces Topline Results from Phase 3 MANTRA Trial of Milademetan for the Treatment of Dedifferentiated Liposarcoma
– The Phase 3 MANTRA trial did not meet the primary endpoint of progression free survival vs. standard of care – – The median PFS was 3.6 months for
About this update from Rain Enhancement Technologies Holdco, Inc.
[{"type":"text","content":"– The Phase 3 MANTRA trial did not meet the primary endpoint of progression free survival vs. standard of care – – The median PFS was 3.6 months for milademetan versus 2.2 months for trabectedin with a hazard ratio of 0.89 – – Rain to host a conference call at 8:30 a.m. ET – NEWARK, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology therapeutics with its lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today announced its topline pivotal Phase 3 MANTRA data. The trial, evaluating the efficacy, safety, and tolerability of milademetan in patients with dedifferentiated (DD) liposarcoma (LPS), did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review compared to the standard of care, trabectedin. The median PFS for milademetan was 3.6 months vs 2.2 months for trabectedin, with a hazard ratio of 0.89, p=0.53. The most common treatment emergent adverse events (TEAEs) in the milademetan arm included nausea, thrombocytopenia, anemia, vomiting and neutropenia. The most common Grade 3/4 TEAEs were thrombocytopenia (39.5%), neutropenia (25.5%) and anemia (18.6%). Dose reductions in the milademetan arm were 44.2% vs 29.1% in the trabectedin arm. Discontinuation in the milademetan arm due to AEs were 11.6% vs 19.0% for trabectedin. Based upon these topline data, Rain does not expect to pursue further development of milademetan in DD LPS. Rain hopes to present the MANTRA data in an upcoming medical conference. “We are very disappointed in the outcome of the MANTRA trial, as the results did not closely mirror prior clinical results in patients with DD LPS,” said Avanish Vellanki, co-founder and chief executive officer of Rain. “We are truly saddened we will not likely be able to offer patients new treatment options for this challenging disease. However, the quality and robustness of the global MANTRA trial reflects an unambiguous data set. Rain’s mission remains to advance science, and therefore we will further evaluate the totality of the MANTRA data to support the scientific and medical community in the hope we can aid others in finding new strategies for patients with DD LPS. Based on the MANTRA topline results, we will also re-evaluate the ...
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