COMUNICADO: New Phase III Data Highlights Excellent Efficacy of Roche's Cancer Drugs Xeloda and Avastin for Treatment of Advanced Co

Actualizado 22/01/2007 8:36:01 CET

BASEL, Switzerland, January 22 /PRNewswire/ --

-- New Phase III Data Presented at the American Society of Clinical Oncology

Gastrointestinal Symposium (ASCO GI) continue to demonstrate the excellent efficacy of two of Roche's innovative cancer drugs Xeloda and Avastin, which offer improved survival for patients with advanced colorectal cancer. The

NO16966 study showed that:

-- XELOX (oral Xeloda plus oxaliplatin) is at least as effective as

FOLFOX-4 in terms of overall survival

-- The addition of Avastin to either XELOX or FOLFOX leads to a statistically significant improvement in progression-free survival, as determined by an independent review committee (IRC)

"Overall, these results confirm the role of XELOX as the most convenient and patient-friendly treatment option in this disease area, which is very encouraging for colorectal cancer patients and healthcare providers," said

Professor Jim Cassidy, co-lead investigator for study NO16966 and Cancer

Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "In addition, the independent review confirms that by adding Avastin to any oxaliplatin-based regimen we can improve progression-free survival times even further, which we knew all along based on the second-line data with FOLFOX plus Avastin."

In the treatment of advanced (metastatic) colorectal cancer, these data showed that XELOX reached its primary endpoint:

-- The chemotherapy combination XELOX is as effective in terms of time patients live without their disease progressing (PFS) as FOLFOX-4.

-- Overall survival data of the first 634 patients enrolled prior to the introduction of Avastin indicate that XELOX is at least comparable to FOLFOX-4.

These data add to the results of previous studies, further endorsing that

Xeloda should replace infused 5-FU/leucovorin in colorectal cancer regimens.

The IRC which conducted a blinded analysis of the scans confirmed that

Avastin reached its primary endpoint:

-- The benefit provided by Avastin when added to chemotherapy (FOLFOX or

XELOX) significantly improved progression-free survival by 43% compared to chemotherapy alone, as assessed by the IRC. A previous analysis presented in

October 2006 showed an advantage of 20%.

-- Specifically there was also a statistically significant improvement in

PFS when assessing the addition of Avastin to either the XELOX or FOLFOX subgroup (p<0.007)

No new safety findings related to Avastin or Xeloda were observed in the trial.

Further analyses are ongoing and updated results will be presented at future scientific meetings. Based on findings from this study and the NO16967 and E3200 studies, Roche will be approaching worldwide regulatory authorities for new file submissions with Xeloda and Avastin respectively in advanced colorectal cancer.

In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers in Europe.(1) A World Health Organization report suggested that in 2005, 655,000 people worldwide died from colorectal

cancer.(2)

Notes to Editors:

About the Study

NO16966

NO16966 is a large, international Phase III trial which finally recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer:

-- XELOX (Xeloda plus oxaliplatin) vs FOLFOX-4 (intravenous bolus and

infusional 5-fluorouracil plus oxaliplatin)

The two-arm study recruited 634 patients.

After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design:

-- XELOX + placebo vs XELOX + Avastin (7.5 mg/kg q3w) vs. FOLFOX + placebo

vs FOLFOX + Avastin (5.0 mg/kg q2w).

The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved results compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.

Results presented previously at the European Society of Medical Oncology

(ESMO) meeting in October 2006 of the entire study population (N=2,034) show that:

-- XELOX is as effective as FOLFOX in terms of PFS (hazard ratio: 1.05; upper limit of the 97.5 percent confidence interval was below the non-inferiority margin of 1.23).

-- Adding Avastin to chemotherapy (FOLFOX and XELOX) significantly improved PFS compared to chemotherapy alone (hazard ratio: 0.83). This means that adding Avastin to either chemotherapy combination improves the chances of delaying progression of the disease by 20 percent.

-- No unexpected safety findings were identified for either XELOX or

Avastin:

-- Adverse events which occurred at a rate greater than 10 percent in any of the treatment arms were: diarrhoea (FOLFOX, 11.2 percent of patients;

XELOX, 20.2 percent of patients), neutropenia (FOLFOX, 43.8 percent of patients, XELOX, 7.0 percent of patients) and neurosensory toxicity (FOLFOX,

16.5 percent of patients; XELOX, 17.4 percent of patients).

-- The percentage of gastrointestinal perforations was 0.6 percent in the

Avastin arms compared to 0.3 percent in the placebo group. Grade 3/4 arterial thromboembolic events occurred in 1.7 percent vs 1.0 percent respectively.

Grade 3/4 proteinuria was reported for 0.6 percent of all patients receiving Avastin. Wound healing complications were not observed in a higher frequency than in the placebo group (0.1 vs 0.3 percent).

About Xeloda (capecitabine)

Xeloda is licensed in more than 90 countries worldwide including the EU,

USA, Japan, Australia and Canada and has been shown to be an effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration

(FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda recently received approval in South Korea for the first-line treatment of patients with locally advanced (metastatic) pancreatic cancer, in combination with gemcitabine. Xeloda is licensed in South Korea for the first-line treatment of stomach cancer.

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar

erythrodysesthaesia).

About Avastin (bevacizumab)

(CONTINUA)

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