RAD001 is active and well tolerated in relapsed NHL

ATLANTA-In aggressive, relapsed non-Hodgkin’s lymphoma, the oral investigational mTOR inhibitor RAD001 (everolimus) has single-agent activity and is well-tolerated for long periods, according to interim results of a phase II study presented at ASH 2007 (abstract 121). Craig B. Reeder, MD, of the Mayo Clinic, Scottsdale, Arizona, reported the results of the Mayo Clinic/Dana-Farber Cancer Institute trial (MAYO-MC048G).

Eligible patients had aggressive histologies, including diffuse large B-cell lymphoma (DLBCL) (54%), mantle cell lymphoma (MCL) (38%), and grade 3 follicular lymphomas. The patients had received a median of 4 prior therapies, with as many as 15. They received RAD001 at 10 mg/d on days 1 to 28 for up to 12 courses.

With patients having received a median of 2 cycles of RAD001 (range, 1 to 16+), the overall response rate was 32% (12 of 37 patients). Responses included 1 complete and 11 partial responses. The response rates for DLBCL and MCL were 35% and 29%, respectively.

Overall time to progression was 3.1 months, and the median duration of response for the 12 responders was 5.5 months, Dr. Reeder reported. Five patients were progression free at 6+ months, and 3 maintained a response at a median of 10.5 months (2.09 to 15.6+ months).

Grade 2 toxicities were hyperglycemia (16%) and hyperlipidemia (11%). Grade 3 toxicities included anemia (11%), neutropenia (16%), thrombocytopenia (30%), and hyperglycemia (11%). Grade 4 hyperlipidemia was reported in one patient (2%).

Dr. Reeder concluded, “The data offer proof of concept that targeting mTOR is clinically relevant in NHL.”