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Updated: Nov 5, 2025

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Did Everolimus Break the Rules?

Shumei Kato1, Ezra E W Cohen2

  • 1Division of Hematology-Oncology, Department of Internal Medicine, University of California, San Diego, Moores Cancer Center, La Jolla, California.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|May 14, 2021
PubMed

Insights

A phase II study investigated everolimus for advanced solid tumors with TSC1/TSC2 or MTOR alterations. While efficacy was limited, this research lays groundwork for future targeted therapy advancements.

Area of Science:

  • Oncology
  • Molecular Biology
  • Pharmacology

Background:

  • Targeted therapies are crucial for advanced solid tumors.
  • Genetic alterations in TSC1/TSC2 or MTOR pathways are implicated in tumor growth.
  • Everolimus is an inhibitor of the mTORC1 pathway.

Purpose of the Study:

  • To evaluate the efficacy of everolimus in patients with advanced solid tumors harboring TSC1/TSC2 or MTOR alterations.
  • To assess the potential of targeting the mTORC1 pathway in this patient population.

Main Methods:

  • Phase II clinical study design.
  • Patient cohort with advanced solid tumors and specific genetic alterations (TSC1/TSC2 or MTOR).
  • Treatment with everolimus (mTORC1 inhibitor).

Main Results:

  • Limited overall efficacy observed with everolimus treatment.
  • The study identified a patient population for potential targeted therapy.

Conclusions:

  • Everolimus demonstrated limited efficacy in this specific patient group.
  • The study provides a foundation for further research into targeted therapies for tumors with TSC1/TSC2 or MTOR alterations.

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