Subcutaneous Herceptin meets Phase III endpoint

Roche (SIX:ROG; OTCQX:RHHBY) said subcutaneous Herceptin trastuzumab met the co-primary endpoints vs. IV Herceptin in the Phase III HannaH trial to treat HER2-positive breast cancer. The two treatments led to comparable serum trastuzumab concentrations during the first eight cycles of treatment and comparable complete pathologic response rates between treatment cycles eight and nine. No new safety signals were observed and adverse events, which included infections and abnormal blood counts, were consistent with that of IV Herceptin. The trial enrolled 596 patients. Roche plans to submit an MAA for subcutaneous Herceptin in Europe in 2012.

Subcutaneous Herceptin is formulated using Enhanze recombinant human hyaluronidase ( rHuPH20) drug delivery technology from Halozyme Therapeutics Inc. (NASDAQ:HALO), which gained $1.15 (19%) to $7.35 on Tuesday. ...