The role of the molecular tumor board: learnings from the ROME trial.

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Journal: NPJ precision oncology

This publication reports on the Phase II ROME trial, a randomized study assessing whether treatment selection guided by comprehensive genomic profiling and a centralized Molecular Tumor Board (MTB) can improve outcomes compared with standard-of-care therapy in patients with advanced solid tumors.

Key points:

  • Population and design:
    • 897 patients with advanced solid tumors were reviewed by an MTB between November 2020 and August 2023.
    • Of these, 400 patients met predefined criteria and were randomized to either MTB-guided personalized therapy or standard-of-care.
  • Basis for MTB-guided therapy:
    • Randomization was primarily driven by the presence of:
      • High tumor mutational burden (TMB)
      • Microsatellite instability (MSI)
      • Actionable genomic alterations, with frequent involvement of the PIK3CA/AKT/PTEN pathway.
    • Patients were excluded mainly because:
      • No actionable alteration was identified, or
      • The matched trial drug was not available.
  • Role of the MTB:
    • The MTB integrated genomic and other molecular data with clinical context to generate individualized treatment recommendations.
    • It functioned as a gatekeeper to refine which patients were likely to benefit from precision strategies and to direct them to appropriate targeted or immunotherapy options, often within trial settings.
  • Main implications:
    • MTBs are essential to operationalizing precision oncology in routine practice, particularly as genomic and multi-omic data become more complex.
    • The trial underscores that not all profiled patients will have an actionable target or practical access to matched therapy, making structured, expert review crucial.
    • Standardization and broader implementation of MTBs are highlighted as key steps to improving patient selection, optimizing use of targeted agents and immunotherapies, and ultimately enhancing clinical outcomes.

The trial is registered as NCT04591431 and 2018-002190-21, with authorization by the Italian medicines agency in July 2020.

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