omniture

New Data Confirm Avastin's(R) Life Extending Benefits in Patients With Advanced Breast Cancer

Roche
2008-12-12 01:36 799

For Non-US and Non-UK Media and Non-Austrian Media Only

First Efficacy Results From Largest Ever Patient Safety Study in Real Life Setting

BASEL, Switzerland, Dec. 15 /PRNewswire-Asia/ -- A wealth of new Avastin (bevacizumab) data presented at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) confirms that Avastin-based therapy is essential for improving the lives of patients with advanced breast cancer. In total, 24 separate data presentations will be given which include the first efficacy and safety data from a study evaluating the benefits of Avastin in combination with a range of chemotherapies in a real life setting.

Large safety study of over 2,000 patients confirms that Avastin can be used with a broad range of chemotherapies

The efficacy benefits and safety profile of Avastin in combination with chemotherapy were confirmed in the Avastin breast cancer safety study MO19391, which combined Avastin with commonly used chemotherapies in women with locally recurrent or metastatic breast cancer. Key results include:

-- Avastin-based therapy delivered a median time to progression (a measure

of time after the cancer is treated until it starts to get worse) of

almost 10 months. This is in line with data from previously reported

phase III clinical trials.(1),(2)

-- Importantly, this trial supports the established safety profile of

Avastin as the Avastin-associated side effects in the broad patient

population recruited were consistent with those reported in other

clinical trials.

-- Further analysis including overall survival data which are still

immature at present and will be presented at a future scientific

congress.

Establishing the safety and therefore tolerability of a treatment is extremely important in advanced breast cancer as patients are often tired having been exposed to a wide range of earlier treatments. Knowing that they have an option that not only extends their time without their disease getting worse, but which does not add significantly to the side effects burden, will be extremely beneficial to patients and the physicians who are helping them manage their disease.

New AVADO analyses confirm the safety of Avastin in patients with

metastatic breast cancer

The AVADO study has already confirmed that Avastin in combination with

docetaxel gave patients a significant improvement in the time patients live without their disease getting worse, with a limited impact on the known safety profile of docetaxel.

Additional AVADO analyses presented in San Antonio confirm the safety associated with the use of Avastin in sub groups of patients: The efficacy of Avastin combined with docetaxel did not correlate with the incidence of hypertension observed in patients in the trial, nor did it affect the number of patients undergoing surgery. In addition, the incidence of thromboembolic and bleeding events did not seem to increase in those patients receiving anticoagulants concurrently with Avastin compared to those receiving chemotherapy alone.

Furthermore, an exploratory analysis of AVADO indicates that treatment with Avastin does not appear to be associated with brain haemorrhage (bleeding) in patients with cancer that had spread to the brain during therapy.

Key Data Presentation:

1. Chan A et al Efficacy of bevacizumab (BV) plus Thursday 11th

docetaxel (D) does not correlate December

with hypertension (HTN) or G-CSF use

in patients (pts) with locally 5:30pm - 7:30pm

recurrent (LR) or metastatic breast

cancer (mBC) in the AVADO phase III Poster Session 1

study Exhibit Hall B

2. Cortes J et al Safety of surgery in patients (pts) Thursday 11th

with locally recurrent (LR) or December

metastatic breast cancer (mBC)

treated with docetaxel (D) plus 5:30pm - 7:30pm

bevacizumab (BV) or placebo (PL) in

the AVADO phase III study Poster Session 1

Exhibit Hall B

3. Wardley A et Effect of anticoagulation therapy on Thursday 11th

al bleeding and thromboembolic events December

(TEs) in the AVADO phase III study

of docetaxel (D) plus or minus 5:30pm - 7:30pm

bevacizumab (BV) in inoperable

locally recurrent (LR) or metastatic Poster Session 1

breast cancer (mBC) Exhibit Hall B

4. Smith IE et al Primary analysis of study MO19391, Saturday 13th

an open-label safety study of December

bevacizumab plus taxane-based

therapy as 1st-line treatment of 7am

patients with locally recurrent or

metastatic breast cancer Poster Session 4

Exhibit Hall B

5. Dirix LY et al Safety of bevacizumab plus docetaxel Saturday 13th

in patients with locally recurrent December

or metastatic breast cancer who

developed brain metastases during 7am

the AVADO phase III study

Poster Session 4

Exhibit Hall B

Additional information

http://www.avastin-info.com

http://www.roche.com

http://www.thenewsmarket.com (video clips about Avastin in broadcast

standard, free of charge)

References

(1) Miller K et al. New Engl J Med 2007; 357: 2666-76

(2) Miles D et al. ASCO 2008, Abstract No. LBA1011, oral presentation

Source: Roche
collection