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Everolimus: in advanced renal cell carcinoma
Karly P Garnock-Jones1, Gillian M Keating
1Adis, Auckland, New Zealand. demail@adis.co.nz
Drugs
|October 2, 2009
Summary
Everolimus significantly improved progression-free survival in advanced renal cell carcinoma patients who progressed on prior therapies. This targeted therapy demonstrated a manageable safety profile in a phase III trial.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced renal cell carcinoma (RCC) presents a significant clinical challenge, often requiring targeted therapies after progression on standard treatments like sunitinib or sorafenib.
- The mammalian target of rapamycin (mTOR) pathway is crucial for cell growth and proliferation, making it a key target for novel cancer therapies.
Purpose of the Study:
- To evaluate the efficacy and safety of everolimus in patients with metastatic renal cell carcinoma (mRCC) who have progressed on prior targeted therapies.
- To compare progression-free survival (PFS) and overall survival (OS) between everolimus and placebo in this patient population.
Main Methods:
- A randomized, double-blind, placebo-controlled, multicentre, phase III trial was conducted.
- Patients with metastatic RCC who had progressed on sunitinib and/or sorafenib were randomized to receive either everolimus (10 mg once daily) or placebo.
- Progression-free survival, overall survival, and objective response rates were assessed.
Main Results:
- Everolimus demonstrated a significantly longer median progression-free survival compared to placebo in both interim (4.0 vs 1.9 months) and updated (4.9 vs 1.9 months) analyses.
- At the second interim analysis, median overall survival was 8.8 months for placebo recipients, while it had not yet been reached for everolimus recipients.
- Objective response rates showed 64% of everolimus recipients achieved partial response or stable disease compared to 32% for placebo recipients.
- The tolerability profile of everolimus was manageable, with most treatment-related adverse events being of grade 1 or 2 severity.
Conclusions:
- Everolimus is an effective targeted therapy for patients with advanced renal cell carcinoma who have progressed on prior treatments.
- Everolimus significantly improves progression-free survival and demonstrates a favorable response rate with a manageable safety profile in this patient group.
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