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MRT-2359 Shows Promise in Prostate Cancer Treatment, Monte Rosa Therapeutics Announces Positive Clinical Data

Monte Rosa Therapeutics (GLUE) | Dec. 16, 2025

By Laura Young

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Monte Rosa Therapeutics released positive interim data from a Phase 1/2 study on MRT-2359 in combination with enzalutamide for metastatic castration-resistant prostate cancer patients.

The study showed a 100% PSA response rate in patients with AR mutations, highlighting the potential of MRT-2359 in heavily pretreated populations.

Combination of MRT-2359 and enzalutamide demonstrated a 64% disease control rate, indicating promising clinical activity.

Promising Clinical Activity

MRT-2359 in combination with enzalutamide achieved a 100% PSA response rate in mCRPC patients with AR mutations.

Signal-Confirming Phase 2 Study

Monte Rosa Therapeutics plans to initiate a new Phase 2 study in 2026 targeting AR mutant and AR signaling-dependent patients.

Biomarker Impact

MRT-2359 impacted the MYC and E2F signaling pathways, supporting its mechanism of action beyond AR signaling inhibition.

  • The Phase 1/2 study reported compelling clinical activity of MRT-2359 in heavily pretreated mCRPC patients, with favorable safety and significant impact on AR mutant populations.
  • Updated MRT-2359 data is anticipated to be presented at the ASCO Genitourinary Cancers Symposium conference in February 2026, underscoring the potential of this novel treatment approach.

The positive interim results of MRT-2359 in combination with enzalutamide offer hope for advanced prostate cancer patients with limited treatment options. Monte Rosa Therapeutics is optimistic about the program's future and the upcoming Phase 2 study.