It was not all doom and gloom for Bayer, which reported disappointing late-stage data for the clotbuster alfimeprase yesterday, as newly-acquired Schering AG and partner Genzyme Corp presented encouraging Phase III data for the cancer drug Campath as a first-line therapy for B-cell chronic lymphocytic leukemia.
The 297-patient trial, data for which was presented at the American Society of Hematology in Orlando, showed that Campath (alemtuzumab) resulted in superior progression free survival compared to chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia, with the former reducing the risk of disease progression or death by 42%.
Secondary endpoint analyses revealed that patients who received Campath, sold as MabCampath in Europe, for a median of nearly twelve weeks exhibited significantly higher overall and complete response rates, with a manageable safety profile, compared with those patients who were treated with chlorambucil for a median of 24 weeks. The data showed a nearly 30% greater overall response rate among patients treated with Campath and a 12-fold increase in complete response rates.
Mark Enyedy, general manager of Genzyme’s oncology business unit, noted that, based on these results, the firms will now work with the US Food and Drug Administration “regarding a supplement to the product labelling to support treatment of patients earlier in the course of their disease.”
Campath is currently indicated for the treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy, and an application to expand its label to cover previously-untreated patients will probably be filed in early 2007, said Schering.
Phase III MS study planned
The companies are also pressing on with plans to start a Phase III study of Campath for the treatment of relapsing/remitting multiple sclerosis, although this strategy has run into difficulties of late. They were forced to halt dosing in a Phase II trial of Campath for MS after a patient died of a serious bleeding disorder. However, the drug’s efficacy was seen to be excellent, cutting the relapse rate in patients by 75% compared to the comparator drug, Serono’s blockbuster Rebif (interferon beta-1a). Furthermore, Campath is given just once a year, while Rebif is administered three times a week, providing another significant treatment advantage.