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Title: "Smart Tablet" Xeloda (Capecitabine) Is Highly Effective And Makes Chemotherapy Easier For Patients: Presented at ASCO

""Smart Tablet" Xeloda (Capecitabine) Is Highly Effective And Makes Chemotherapy Easier For Patients: Presented at ASCO"

New data presented at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Orlando ORLANDO, FL -- May 24, 2002 -- Xeloda (capecitabine), Roche's innovative new oral tumour-activated chemotherapy treatment, is highly effective at treating gastrointestinal cancers (colorectal, stomach and oesophageal cancers), according to data presented at the 38th Annual Meeting of the American Society for Clinical Oncology (ASCO) in Orlando today. Various study results presented at the ASCO meeting show that oral Xeloda has the potential to effectively replace the current standard treatment, intravenous (iv) 5-FU, in gastrointestinal cancers. Xeloda monotherapy is already approved in most countries world-wide for the treatment of colorectal cancer. This approval was based on two studies involving more than 1200 patients showing better tumour shrinkage with Xeloda than 5-FU. Studies presented at the ASCO meeting show Xeloda's efficacy by itself in stomach cancer and also in chemotherapy combinations against both colorectal and stomach/oesophageal cancers. In addition to improved anti-cancer effectiveness, Xeloda dramatically reduces the burden for patients over conventional iv cancer treatment by avoiding lengthy and expensive hospital stays and painful injections, offering greater convenience to patients in comparison to iv 5-FU given by pumps. "Xeloda is an important new development in the treatment of gastrointestinal cancers," said Dr David Cunningham, of the Royal Marsden Hospital in the United Kingdom and lead investigator of one of the studies presented at ASCO. "Not only is it now an established treatment for colorectal cancer, the recent data from our own randomised trial would indicate it is likely to also have a pivotal place in the treatment of oesophageal and gastric cancers." Xeloda can free patients from the burden of inconvenient iv 5-FU therapy, where patients have to wear surgically implanted devices tunnelled under the skin to deliver the drug. The chemotherapy is pumped through these devices day and night, meaning that patients are unable to live their normal life; for instance sleeping is disturbed, wearing a car seatbelt is highly uncomfortable and even taking a shower is very difficult. "Xeloda also offers a significantly superior toxicity profile when compared to the standard chemotherapy schedule of iv 5-FU. In particular, Xeloda greatly reduces the life-threatening toxicity of neutropenia with diarrhoea," Dr Cunningham said. "It also promises to be a much better partner for combination with other modern cancer treatments such as irinotecan and oxaliplatin, as combining iv bolus 5-FU with such drugs can be associated with life-threatening side effects." Gastrointestinal Cancers Over a quarter of all cancer deaths worldwide are caused by gastrointestinal cancers (oesophagus, stomach, pancreas, colon and rectum), making them the most common cause of cancer-related death among men and women. According to the World Health Organisation, over two million people suffered from gastrointestinal cancers in 2000, with over 80% of them dying from the disease.1 Xeloda is Tumour-Activated Xeloda has been dubbed a "smart tablet" because of its novel mechanism of activation which occurs predominantly inside the cancer. Xeloda is activated by an enzyme, thymidine phosphorylase (TP), which is found at higher levels in cancer than in healthy tissue.2 Xeloda is therefore converted to the cancer-killing agent 5-FU preferentially at the site of the cancer,3 where it is needed. Xeloda Indications and Licensing Status Roche received marketing authorisation for Xeloda in the treatment of metastatic colorectal cancer in most countries worldwide, including the United States and Europe, last year. In addition, Xeloda is registered in more than 70 countries worldwide for the treatment of metastatic breast cancer. Xeloda in combination with Taxotere for the treatment of patients with metastatic breast cancer is registered in the U.S., Canada and in the European Union. Xeloda development in additional cancer indications and in combination with other cancer treatments is ongoing. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life. Roche is a world leader in oncology. Its franchise includes Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea). Xeloda demonstrates improved tumour shrinkage with fewer side effects in oesophago-gastric cancer In a large randomised, multi-centre phase III clinical trial, Xeloda was compared to iv 5-FU in combination with other chemotherapy agents (cisplatin or oxaliplatin and epirubicin) in patients with stomach and oesophageal cancer. Interim results presented today demonstrated that patients treated with the triple drug combination containing Xeloda tablets had better tumour shrinkage (in 49 % vs 22 % of patients) and fewer side effects than those treated with the combination containing daily continuous 5-FU infusion, using pumps and under-the-skin devices.4 This trial is ongoing. In addition, a South Korean phase II trial of 44 patients with stomach cancer found that Xeloda by itself showed very promising tumour shrinkage. Eleven patients (28 %) had substantial tumour shrinkage with Xeloda and in a further 14 patients (36%) Xeloda halted tumour growth, with few side effects and none of the inconvenience of iv chemotherapy.5 Xeloda highly effective in colorectal cancer Because 5-FU has been the most widely used chemotherapy in gastrointestinal cancer for many decades, the potential for oral Xeloda to replace inconvenient iv 5-FU is not limited to stomach cancer. Interesting results were also seen in a large colorectal cancer trial, presented at the annual meeting of ASCO. Results of this global phase II trial showed that Xeloda in combination with oxaliplatin was highly effective in substantially shrinking the tumours of more than half the patients. Tumour growth was halted for around eight months (on average) thanks to the Xeloda/oxaliplatin combination. Encouragingly, the majority of patients survived over one year. This result compares favourably with standard colorectal cancer treatment (iv 5-FU/leucovorin + oxaliplatin), which requires permanent under-the-skin devices.6 In addition the Xeloda/oxaliplatin combination demonstrated a remarkable safety profile. Xeloda in combination with irinotecan holds promise for colorectal cancer patients Another two trials presented at ASCO have shown that Xeloda can also be effectively combined with another important colorectal cancer drug, irinotecan, which again potentially eliminates iv 5-FU therapy by replacing it with oral Xeloda. Up until now irinotecan has always been given with iv 5-FU. A Dutch/UK phase I trial (now recruiting for phase II) demonstrated that 48 % of patients treated with Xeloda and irinotecan had substantial tumour shrinkage and in a further 41 % of patients tumour growth was halted.7 Preliminary results of a phase I multi-centre French trial will also be presented at ASCO and confirm the results of the Dutch/UK trial.8 Because of these encouraging results, a phase III multinational trial will begin shortly to test the Xeloda/irinotecan combination in metastatic colorectal cancer. References: 1. World Health Organisation. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide. 2000 2. Miwa M, Ura M, Nishida M et al. Eur J Cancer 1998; 34: 1274-1281 3. Schüller J, Cassidy J, Dumont E et al. Cancer Chemotherapy. Pharmacol 2000; 45: 291-297 4. Tebbutt N, Norman A, Cunningham D et al. Randomised, multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophago-gastric cancer; interim analysis. Proc Am Soc Clin Oncol 21: 2002 (abstr 523) 5. Hong YS, Song SY, Cho JY,et al. A phase II trial of capecitabine (Xeloda®) in chemotherapy naïve patients with advanced and/or metastatic gastric cancer. Proc Am Soc Clin Oncol 21: 2002 (abstr 623) 6. Tabernero J, Butts CA, Cassidy J et al. Capecitabine and oxaliplatin in combination as first line therapy for patients with metastatic colorectal cancer: results of an international multicenter phase II trial. Proc Am Soc Clin Oncol 21: 2002 (abstr 531) 7. Kerr DJ, Ten Bokkel Huinink WW, Ferry DR et al. A phase I/II study of CPT-11 in combination with capecitabine as first line chemotherapy for metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 21: 2002 (abstr 643) 8. Delord JP, Pierga JY, Dieras V et al. Dose escalation and pharmacokinetic study of capecitabine (Xeloda ®) and irinotecan (CPT-11) in gastro-intestinal tumours. Preliminary results. Proc Am Soc Clin Oncol 21: 2002 (abstr 397) SOURCE: Roche Pharmaceuticals Business Communications

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