BioCentury
ARTICLE | Clinical News

Bendamustine: Updated Phase III data

March 4, 2013 8:00 AM UTC

Updated data from the open-label, German Phase III StiL NHL-1 trial in 549 patients with newly diagnosed stage 3/4 indolent NHL or mantle cell lymphoma (MCL) showed that first-line therapy with bendamustine plus rituximab significantly improved median PFS, the primary endpoint, vs. R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) at a median follow-up of 45 months (69.5 vs. 31.2 months, p<0.0001). Bendamustine plus rituximab also significantly improved the complete response rate vs. R-CHOP (40% vs. 30%, p=0.021). Bendamustine plus rituximab was better tolerated than R-CHOP, with lower rates of alopecia, hematological toxicity, infections, peripheral neuropathy and stomatitis. Erythematous skin reactions were more common in patients in the bendamustine plus rituximab group than in those in the R-CHOP group. Mundipharma said the StiL NHL-1 data have been submitted to regulatory authorities. Data were published in The Lancet and were previously reported in 2008 and 2009 (see BioCentury, Dec. 15, 2008 & Nov. 16, 2009).

Last October, Teva said FDA issued a complete response letter for an sNDA for Treanda for first-line treatment of indolent B cell NHL in combination with rituximab. The agency asked for additional PFS data from the Phase III Study 3064 trial. At the time, Teva said it is evaluating its options and is requesting a meeting with FDA (see BioCentury, Oct. 29, 2012). Cephalon Inc., which Teva acquired, markets the drug in the U.S. to treat chronic lymphocytic leukemia (CLL) and indolent B cell NHL in patients refractory to rituximab. ...