Genentech reports Herceptin phase III survival benefits

Study data showed that, after four years, 15% of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 33% of women treated with chemotherapy alone. Preliminary survival data showed a 49% improvement in overall survival and survival data continue to mature.

“The reduction in disease recurrence observed in these trials was the largest improvement I’ve seen in breast cancer clinical research. Herceptin plus chemotherapy can potentially stop or delay early-stage HER2-positive breast cancer from relapsing,” said Dr Edith Perez, professor of medicine at the Mayo Clinic and lead investigator in one of the two Herceptin trials. “These trials also underscore the importance for every woman diagnosed with breast cancer to receive a HER2 test.”

A preliminary safety analysis showed that adverse events in these studies were consistent with those seen in previous Herceptin clinical trials. According to the investigators, serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure occurred approximately 3 to 4% more often in the Herceptin plus chemotherapy arms than in the chemotherapy alone arms. Patients in these studies will continue to be followed for any additional side effects.

Based on the strength of this interim joint analysis, Genentech will work to prepare these data for discussion with the FDA about filing a supplemental biologics license application (sBLA) for Herceptin in the adjuvant setting.