Rain Therapeutics Provides Interim Analysis of Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)
– Two patients exhibited an unconfirmed partial response at their first scan, and two additional patients saw promising tumor regression activity out of ten efficacy evaluable patients, demonstrating monotherapy activity of milademetan in MDM2-amplified patients –
– Drug safety profile of milademetan preliminarily consistent with prior Phase 1 trial –
– Protocol amendment planned to adjust MDM2 copy number (CN) threshold to CN ≥8 from CN ≥12; MANTRA-2 continues to enroll –
Excerpt from the Press Release:
NEWARK, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) — Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead clinical candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today announced preliminary data in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors.
“We are encouraged by the preliminary observations from the MANTRA-2 trial,” said Avanish Vellanki, co-founder and chief executive officer of Rain. “Treatment with milademetan led to tumor regression in patients previously treated with a multitude of therapies across a range of cancers. We look forward to expanding this dataset as the trial continues to enroll.”
Dr. Richard Bryce, MBChB, chief medical officer of Rain continued, “In the first ten evaluable patients, we have observed activity with two unconfirmed partial responses (PRs) at their first scan and promising tumor regression activity in two patients following milademetan monotherapy. In addition, anti-tumor activity was observed in patients with genetic co-alterations, and in tumors with MDM2 copy number above 8. Hence, we plan to revise the protocol to include patients tested locally for MDM2 copy number of 8 and greater. We are encouraged by these preliminary data and we look forward to continuing the trial and evaluating additional data as they become available in the coming months.”
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