Roche has suffered a setback after Avastin failed in a late-stage study evaluating the blockbuster as a treatment for advanced stomach cancer.

The Swiss major has announced topline results from a Phase III trial investigating the use of Avastin (bevacizumab) in combination with the company’s Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in 774 patients with inoperable, advanced or metastatic gastric cancer. The study, called AVAGAST, did not meet its primary endpoint of extending overall survival in patients treated with Avastin in combination with chemotherapy compared to the same chemotherapy plus placebo.

Roche’s chief medical officer Hal Barron admitted that “we are disappointed with these results because treatment options for stomach cancer are limited.” However, the firm will present the full data, including secondary endpoints (such as progression free survival and overall response rate) at the American Society of Clinical Oncology meeting in June, and Dr Barron added that Roche is “committed to developing medicines for people with stomach cancer, including Herceptin (trastuzumab) and Xeloda.”

These findings are a bit of a blow to Roche seeing as how it hoped sales of Avastin in this indication alone could be worth between $500 million-$1 billion. The drug, which is approved in the USA and Europe for the treatment of advanced stages of colorectal breast, non-small cell lung and kidney cancers (and also across the pond for glioblastoma, contributed 6.22 billion Swiss francs to Roche’s coffers last year. Over 450 clinical trials are investigating the use of Avastin in various tumour types and different settings, the company concluded.

Meantime, Roche has announced that the European Medicines Agency's Committee on Human Medicinal Products has recommended that Xeloda should be used in combination with Sanofi-Aventis' Eloxatin (oxaliplatin) for the post-surgery treatment of patients with early colon cancer.