Ridaforolimus Well-Tolerated, Improves PFS in Metastatic Sarcoma Patients

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(CHICAGO, IL) – Oral ridaforolimus is generally well tolerated and significantly improves progression-free survival (PFS) in metastatic sarcoma patients, according to the results of the phase 3 SUCCEED trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Ridaforolimus, an oral mTOR inhibitor, demonstrated clinical activity in previous nonrandomized trials in advanced sarcomas following failure of prior chemotherapy, but its role as a maintenance therapy in the this disease is unknown, said lead study author Jean-Yves Blay, MD, PhD, Professor of Medicine in Medical Oncology and Head of the Medical Oncology Department at University Claude Bernard in Lyon I, Centre Léon Bérard, Lyon, France

The SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus) trial was an international, multicenter, placebo-controlled, phase 3 trial designed to evaluate maintenance therapy with ridaforolimus in patients with metastatic soft-tissue or bone sarcomas who achieved disease control from prior chemotherapy. Patients were randomized to either the experimental arm (oral ridaforolimus, 40mg once daily, 5 days per week) or the placebo arm, and followed to a primary end point of PFS. Secondary end points included overall survival (OS), safety, and tolerability. For OS, patients were to be followed at 3-month intervals for at least 24 months and up to 60 months after randomization.

Of the 711 eligible patients, 702 received treatment. Ridaforolimus significantly improved the primary endpoint of PFS vs placebo with median PFS of 17.7 weeks vs 14.6 weeks (HR=0.72; 95% CI: 0.61, 0.85; P=0.0001). PFS improved across all pre-specified baseline characteristics. At the time of the data cutoff for OS (478 deaths), patients in the study population had been followed for at least 15 months. Median OS was 88.0 weeks with ridaforolimus vs 78.7 weeks with placebo (HR=0.92; 95% CI: 0.78–1.12; P=0.45). The most common adverse events were those anticipated for an mTOR inhibitor, namely stomatitis, thrombocytopenia, fatigue, hypertriglyceridemia, hyperglycemia, infections, and rash.

Dr. Blay and colleagues concluded that, “oral ridaforolimus was generally well tolerated and significantly improved PFS in metastatic sarcoma patients with benefit from prior chemotherapy, offering an effective treatment alternative to surveillance alone.”

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