Treatment with Roche’s oncology agent, Hercpetin (trastuzumab) doubles the number of long-term survivors with an aggressive form of metastatic breast cancer, known as HER2-positive, according to new trial results from the Swiss firm.
The data, which were presented at the American Society of Clinical Oncology annual meeting, come from a two-year follow-up trial, which investigated Herceptin in combination with Sanofi-Aventis’ Taxotere (docetaxel), versus the latter drug alone as a first-line treatment in HER2-positive patients with metastatic disease. Long-term follow-up now shows that twice as many patients who received the combination therapy are still alive three years after starting therapy (33% versus 16%). The combination also significantly prolonged life by more than one-third (31 months versus 23 months), which Roche notes is “highly statistically significant” in this patient population.
“These data confirm the impressive durability of response with Herceptin in the treatment of metastatic breast cancer and will provide great hope to thousands of patients,” said principal study investigator, Professor Michel Marty, head of therapeutic innovation in Onco Haematology at Saint Louis University Hospital, Paris, France. “There is now firm evidence from two large randomised studies that Herceptin provides significant survival benefit for women with HER2-positive metastatic breast cancer.”
– Meanwhile, Roche received a further boost on news that the European Commission’s advisory board, the CHMP, had said that the firm’s weight loss medicine, Xenical (orlistat), could include data on its use in obese adolescents aged 12 years and over. Once the decision receives final EC backing, the Swiss company notes that Xenical will be the only weight loss treatment in either the US or Europe that provides data on use in adolescents.
The label change is based on data from a large study in which 539 obese adolescent patients received either 120mg Xenical or placebo three times daily alongside a reduced-calorie diet and exercise for one year. At the end of treatment, the Xenical group had a significantly reduced body mass index versus placebo, which was associated with greater loss of body fat in the Xenical group. Adolescents treated with Xenical plus diet also had significantly greater reductions in body weight.
