R1549 does not meet primary endpoint in phase III study in ovarian cancer
26 April 2004
Roche and Antisoma announced today that they have completed SMART (Study of Monoclonal Antibody RadioimmunoTherapy), a phase III study of R1549 in ovarian cancer. The outcomes for R1549-treated patients appeared no better than those of patients in the comparative arm of the trial. Given these findings, it is unlikely that development of R1549 will continue. A more detailed analysis of the data from SMART will be completed. The trial provides an extensive clinical database which may be of interest for future research into ovarian cancer.
Commenting on the result, Glyn Edwards, CEO of Antisoma said “We’re obviously disappointed by the R1549 result, but will now have the opportunity to focus all our efforts on the strong, diverse and rapidly advancing pipeline of other drugs we have in development. We’re also confident that we will add further to our clinical portfolio by the end of this year.”
William M. Burns, Head of Roche's Pharmaceuticals Division, said “Drug development is a high-risk endeavour and such results are not unexpected in the development of novel treatment modalities. The outcome of this study will have no impact on our growth outlook and we remain committed to our long-term relationship with Antisoma, which is based upon multiple products. Commercially more important, Roche also announced today highly significant phase III data on Tarceva in non-small cell lung cancer which will be the next regulatory submission of a major product contribution to the treatment of cancer. The Roche group will be in the unparalleled position of having five cancer medicines with a proven survival benefit - Herceptin, MabThera, Xeloda, most recently Avastin and now Tarceva.”
Antisoma and Roche are co-developing a number of drugs under the broad strategic alliance formed in November 2002. These include R1550, a humanised monoclonal antibody in phase I trials for breast cancer, and AS1404, a small-molecule vascular targeting agent, that is expected to start a phase II programme of combination studies later this year.
Enquiries:
Antisoma plc:
Glyn Edwards,
Chief Executive Officer
Tel: +44 20 8799 8200
Financial Dynamics:
Julia Phillips
Ben Atwell
Tel: +44 (0)20 7831 3113