Roche reported hitting its primary endpoint in the latest test of its antibody, pertuzumab, used in combination with Herceptin and docetaxel for the treatment of Her2-positive breast cancer patients. The combination therapy reportedly worked better than Herceptin and docetaxel alone as measured by progression-free survival (PFS).
Roche says it plans to file for approval with the FDA before the end of 2011. Some industry analysts, however, questioned whether PFS improvements alone would be enough to sway the FDA to approve without more data on overall patient survival.
With pertuzumab, Roche has at least found a new way to target Her2 (found in about 25% of breast cancers). It is the same receptor that Roche's other drug Herceptin targets but hits a different region of the receptor for a multi-pronged attack of the cancer. Combination therapies of mutliple antibodies and/or chemotherapeutic agents are becoming a more predominant means of attacking cancers. See Fierce Biotech.
Posted by Bruce Lehr July 15th 2011.