RAD001 Improves Survival in Renal Cancer Patients Failing Targeted Therapies: Presented at ESMO

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Title: RAD001 Improves Survival in Renal Cancer Patients Failing Targeted Therapies: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C806.htm
Doctor's Guide
September 16, 2008

By Jill Stein

STOCKHOLM -- September 16, 2008 -- Treatment with once-daily oral RAD001 results in more than double the progression-free survival (PFS) achieved in patients with advanced renal cell carcinoma who do not respond to conventional treatment, according to a study presented here at the 33rd European Society for Medical Oncology Congress (ESMO).

Bernard Escudier, MD, Immunotherapy and Innovative Therapy Unit, Institut Gustave Roussy, Villejuif, France, in a presentation on September 16, discussed updated results of the Renal Cell Cancer Treatment With Oral RAD001 (RECORD-1) study.

The study is the largest phase 3 trial to date to examine the effects of an oral mammalian target of rapamycin (mTOR) inhibitor in patients with metastatic renal cell cancer whose cancer worsened after they were treated with the multitargeted receptor tyrosine kinase inhibitors sorafenib or sunitinib, or these agents in combination.

An earlier analysis of the RECORD-1 data showed that RAD001 decreased the risk of disease progression by 70% (P < .0001).

The study randomised 410 patients in a 2:1 design to treatment with RAD001 10 mg/day or placebo in patients receiving best supportive care. Participants in the trial were stratified according to Memorial Sloan-Kettering Cancer Center risk criteria and prior anticancer therapy.

The primary endpoint was PFS that was evaluated by blinded, independent central review. Secondary trial endpoints included overall survival, safety, and quality of life.

The updated results showed a PFS of 5 months in patients randomised to RAD001 and 1.9 months in the placebo cohort, for a risk reduction of 67% (P < .001).

Twenty-five percent of patients experienced PFS beyond 10 months.

In addition, RAD001 prolonged PFS compared with placebo irrespective of prior treatments, risk status, age, or gender.

The study found no significant difference in overall survival between the active and placebo groups (P = .137).

The safety findings in the study were consistent with those seen in phase 2 trials of RAD001 and most often included mouth sores, rash, weakness, and fatigue.

No significant difference between RAD001 and placebo groups were seen in the effects of treatment on quality of life, Dr. Escudier said.

The trial was stopped earlier this year after interim results showed that RAD001-treated patients had a significantly longer PFS survival than placebo-treated patients.

"The findings are extremely important because they demonstrate for the first time that a drug can show significant benefit after approved therapies have failed, thereby satisfying an unmet medical need," Dr. Escudier commented.

He added that RAD001 is the first and only drug with documented clinical benefit for the treatment of patients with renal cell cancer after failure of vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy.

RAD001 was recently granted priority review by the US Food and Drug Administration as treatment for advanced renal cell carcinoma. A marketing authorisation application has also been filed in the European Union and Switzerland.

Funding for the study was provided by Novartis.

[Presentation Title: Phase 3 Randomized Trial of Everolimus (RAD001) Versus Placebo in Metastatic Renal Cell Carcinoma. Abstract 72O]

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