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Eve4.2

Everolimus – Forschung

Überwiegend Mechanismus / Beobachtung

7 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

Die meisten Studien zu Everolimus sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.

Die meiste Evidenz stammt aus mittelwertigen randomisierten Studien, veröffentlicht 2008–2025 mit einer typischen Studiengröße von 410 Teilnehmenden.

Basierend auf 7 Studien · 5 RCTs · 1,616 Teilnehmende insgesamt

Konfidenz

Hohe Konfidenz

Nach Outcome

Aging & healthspan (emerging)
Überwiegend Mechanismus / Beobachtung5 Studien
Immune & vaccine responseRandomisierte Studien zeigten, dass niedrig dosiertes Everolimus die Reaktion auf den Influenza-Impfstoff verbesserte und ein TORC1-selektives Regime Infektionen bei älteren Erwachsenen reduzierte · Wochen der Einnahme rund um die Impfung
Überwiegend Mechanismus / Beobachtung4 Studien
Oncology (approved use)
Zu wenige bewertete Studien2 Studien
Safety profile
Zu wenige bewertete Studien1 Studie

Aktives Forschungsgebiet

3 Studien in den letzten 5 Jahren

200820162025

1RCTn=410 · medium study2008

Everolimus prolonged progression-free survival relative to placebo in patients with metastatic renal cell carcinoma whose disease had progressed on VEGF-targeted therapy.

Motzer, Escudier, Oudard, Hutson, Porta, Bracarda · Lancet (London, England) (2008)

RECORD-1: pivotal phase III RCT of everolimus 10 mg/day vs placebo in metastatic renal cell carcinoma (n=410)
Significantly prolonged progression-free survival — the registration trial that established everolimus as an oncology drug
Confirms everolimus pharmacology, dosing, and the immunosuppressant safety profile in humans

Quelle ansehen

2RCTn=724 · large study2012

Everolimus combined with exemestane improved progression-free survival in HR-positive advanced breast cancer (BOLERO-2).

Baselga, Campone, Piccart, Burris, Rugo, Sahmoud · The New England journal of medicine (2012)

BOLERO-2: pivotal phase III RCT of everolimus + exemestane vs exemestane in HR-positive advanced breast cancer
More than doubled progression-free survival — a second registration-grade RCT for everolimus
Reinforces the human dosing and toxicity profile (stomatitis, pneumonitis, hyperglycemia) at oncology doses

Quelle ansehen

3RCTn=218 · medium study2014

RAD001 (everolimus) enhanced the response to the influenza vaccine by about 20% at doses that were relatively well tolerated.

Mannick, Del Giudice, Lattanzi, Valiante, Praestgaard, Huang · Science translational medicine (2014)

Randomized, placebo-controlled trial of low-dose everolimus (RAD001) in elderly volunteers
Improved the antibody response to influenza vaccination by ~20% and reduced PD-1 exhaustion marker on CD4/CD8 T cells
The best human signal that mTOR inhibition can partially reverse immunosenescence

Quelle ansehen

4RCTn=264 · medium study2018

A low-dose combination including everolimus (RAD001) that selectively inhibits TORC1 was associated with a significant decrease in the rate of infections reported by elderly subjects.

Mannick, Morris, Hockey, Roma, Beibel, Kulmatycki · Science translational medicine (2018)

Phase 2a randomized, placebo-controlled trial in 264 elderly subjects (low-dose BEZ235 + everolimus, selective TORC1 inhibition)
Significantly decreased the rate of infections (P=0.001) reported over the year after dosing, and up-regulated antiviral gene expression
Improved influenza-vaccine response — extends the immune-aging signal from biomarkers to a clinical infection endpoint

Quelle ansehen

5RCT2021

In the phase 3 PROTECT trial, RTB101 did not significantly reduce the percentage of older adults with clinically symptomatic respiratory illness.

Mannick, Teo, Bernardo, Quinn, Russell, Klickstein · The lancet. Healthy longevity (2021)

Phase 2b and phase 3 (PROTECT) randomized, placebo-controlled trials of the mTOR inhibitor RTB101 in adults aged ≥65 to prevent respiratory illness
The phase-3 trial MISSED its primary endpoint — RTB101 did not significantly reduce clinically symptomatic respiratory illness
Mandatory counter-evidence: the program's larger confirmatory effort failed to replicate the earlier infection-reduction signal

Quelle ansehen

6Systematische Übersicht2022

Preclinical studies show a role for rapamycin and its analogues (rapalogues) in age-related musculoskeletal disorders, but the applicability to humans is unknown.

Lin, Salech, Lim, Vogrin, Duque · Aging clinical and experimental research (2022)

PRISMA systematic review of rapamycin and rapalogues (including everolimus) on age-related musculoskeletal disorders in humans
Strong preclinical mTORC1-inhibition rationale, but human evidence is sparse and inconclusive
Top-of-pyramid synthesis showing the human geroscience evidence base remains thin

Quelle ansehen

7Übersicht2025

mTOR inhibitors such as rapamycin and everolimus are among the leading candidate geroprotectors, but no agent has yet been shown to extend human healthspan.

Kritchevsky, Cummings · JAMA (2025)

Translational review of the geroscience field and candidate geroprotective drugs
Frames mTOR inhibition (rapamycin/rapalogs) and the immune-aging trials within the broader evidence base
Reiterates that no drug has demonstrated human healthspan/lifespan extension

Quelle ansehen

In der Forschungsbibliothek ansehen

Everolimus – Forschung

Überwiegend Mechanismus / Beobachtung

Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial.

Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer.

mTOR inhibition improves immune function in the elderly.

TORC1 inhibition enhances immune function and reduces infections in the elderly.

Targeting the biology of ageing with mTOR inhibitors to improve immune function in older adults: phase 2b and phase 3 randomised trials.

The effect of rapamycin and its analogues on age-related musculoskeletal diseases: a systematic review.

Geroscience: A Translational Review.