R1549 Does Not Meet Primary Endpoint In Phase III Study In Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Apr 2004 - 0:00 PDT

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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.

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."

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.'

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.

About the SMART study

SMART (Study of Monoclonal Antibody RadioimmunoTherapy) is a phase III randomised, single-blinded parallel group trial that began in 1998. The trial included more than 420 women with ovarian cancer in seventeen countries and compares patients who received standard care plus R1549 with patients who received standard care alone. Women receiving R1549 were given a single dose of the drug via a catheter into the abdomen (intraperitoneal administration) after surgery and chemotherapy.

R1549

R1549 is a monoclonal antibody linked to the radioactive isotope yttrium-90 using a chelating agent (linker) CITC-DTPA. The antibody component binds to a protein (MUC1) found on the surface of ovarian cancer cells.R1549 was originally developed at the Imperial Cancer Research Fund (now Cancer Research UK) in London. Antisoma licensed the drug from Imperial Cancer Research Technologies (now Cancer Research Technologies) in 1996.

Roche Antisoma Collaboration

In November 2002, Roche and Antisoma entered into an expansive alliance to provide Roche with access to Antisoma's broad portfolio of oncology compounds. To date, two compounds have been incorporated into Roche's clinical portfolio (R1549 and R1550 a humanized monoclonal antibody targeting MUC1). Additionally, Roche maintains the option, effective for the first five years of the collaboration, to license any of Antisoma's preclinical oncology compounds when they start clinical trials. Roche currently holds a minority equity stake in Antisoma.

Roche in Oncology

Within the last five years the Roche Group has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin which has been launched in the US recently, treat a range of malignancies such as breast cancer, non-Hodgkin's lymphoma and colorectal cancer.

Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche's cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

Based on a positive phase III study Tarceva, the first and only EGFR-targeted drug, showed improved survival in patients with non-small cell lung cancer.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

About Antisoma

Based in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. The Company fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the pre-clinical and clinical development of these drug candidates. Antisoma forms partnerships with pharmaceutical companies to bring its products to market. Visit www.antisoma.com for further information about Antisoma.

All trademarks used or mentioned in this release are legally protected.

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