Genentech Announces Top-line Results Of Phase III MARIANNE Trial

(RTTNews) - Genentech, a member of the Roche Group (RHHBY.PK, ROG.SW, RO.SW) reported top-line results of the Phase III MARIANNE study. The trial evaluated three HER2-targeted regimens - Kadcyla plus Perjeta, Kadcyla alone, and Herceptin plus taxane chemotherapy in people with previously untreated (first-line) advanced HER2-positive breast cancer.

The 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. Neither Kadcyla-containing treatment arm significantly improved PFS compared to Herceptin plus chemotherapy. Adverse events seen in the two experimental arms of the study were generally consistent with those seen in previous studies of Kadcyla and/or Perjeta.

Kadcyla and Perjeta have been shown to extend survival in their approved uses for advanced HER2-positive breast cancer. Kadcyla is approved for people with previously treated disease. Perjeta is approved in combination with Herceptin and chemotherapy for people with previously untreated disease (first line).

Kadcyla is an antibody-drug conjugate being studied in HER2-positive cancers. It is the first ADC to result from Genentech's 30 years of HER2 pathway research and the third medicine Genentech has developed for the treatment of HER2-positive breast cancer. Genentech licenses technology for Kadcyla under a deal with ImmunoGen, Inc. (IMGN).

Roche expects data from the MARIANNE trial to be reported at an upcoming medical meeting, and to discuss the findings with appropriate regulatory authorities. This event will have no impact on ImmunoGen's forecast for the company's 2015 fiscal year, or on the approved use of Kadcyla, ImmunoGen noted.