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Friday, 12/19/2014 1:11:05 PM

Friday, December 19, 2014 1:11:05 PM

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Roche has reported the MARIANNE study showed the three regimens helped people live without their disease worsening (PFS) for a similar amount of time, meeting its non-inferiority endpoint as assessed by an Independent Review Committee. However, neither Kadcyla-containing treatment arm significantly improved PFS compared to Herceptin and chemotherapy. Adverse events observed in the two experimental arms of the study were generally consistent with those seen in previous studies of Kadcyla and/or Perjeta.

“While we are disappointed by this unexpected outcome, we are pleased that so many patients can benefit from Kadcyla with its already approved use and also with the breadth of Roche’s Kadcyla clinical development program,” commented Daniel Junius, President and CEO. “Roche has a number of other trials underway with Kadcyla, and in 2015 expects data and – if positive – regulatory submission from its GATSBY study in gastric cancer.”
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