Avastin Shows Longest Overall Survival for Patients With Adenocarcinoma, the Most Common Type of Advanced Lung Cancer

Basel, Switzerland, August 6, 2010 (ots/PRNewswire) - This update
outlines data from a preplanned analysis of the pivotal E4599 study
in patients with non-small cell lung cancer (NSCLC), published in the
Journal of Thoracic Oncology. The analysis looked at the impact of
treatment with Avastin® (bevacizumab) in combination with
paclitaxel/carboplatin chemotherapy, according to histology subgroup
of NSCLC.

Outstanding survival benefits:

- The results demonstrate that first line Avastin-based therapy provided
the longest median overall survival (OS) duration yet shown in a phase
III trial of patients with advanced non-small cell adenocarcinoma of the
lung, at 14.2 months, versus 10.3 months with chemotherapy alone
(HR = 0.69, 95% CI: 0.58-0.83).[1] This represents an impressive 3.9
month improvement in OS over chemotherapy alone. Adenocarcinoma is both
the most common form of lung cancer and the most common form of NSCLC.
[2],[3]
- Fifty-seven percent of patients with adenocarcinoma who received
Avastin-based therapy were alive after one year (95% CI: 0.508-0.621)
compared to 43% of patients who received chemotherapy alone (95% CI:
0.376-0.490). In addition, 27% of patients who received Avastin-based
therapy were alive after two years (95% CI: 0.216-0.326) compared to 17%
of patients who received chemotherapy alone (95% CI: 0.121-0.216).[1]
- Median progression free survival (PFS) for patients with adenocarcinoma
histology was 6.6 months with Avastin-based therapy versus 5 months for
chemotherapy alone (HR=0.65, 95%CI: 0.54-0.78).[1]

Consistent safety profile:

- The safety profile in the present analysis was consistent across types
of NSCLC, confirming Avastin's well established and manageable safety
profile.

E4599 treatment impact by NSCLC type - background

E4599 is a US-based international phase III trial, conducted by
the Eastern Cooperative Oncology Group (ECOG). The primary analyses
were originally published in The New England Journal of Medicine in
2006[4]. The current analysis included 878 patients with newly
diagnosed recurrent or advanced NSCLC; the predominant tumor
histology was adenocarcinoma (68.8%). Patients were randomly assigned
to receive (1) treatment with Avastin (15 mg/kg, day 1), paclitaxel
(200 mg/m2, day 1) and carboplatin (6 mg/ml, day 1) or (2) treatment
with paclitaxel-carboplatin alone. The primary end point of the study
was OS. The effects of histology type on duration of survival and PFS
were preplanned in the statistical analysis plan of the trial.

Clinical relevance

- These findings confirm the outstanding efficacy of Avastin in the E4599
overall population, which showed that Avastin-based therapy was the first
treatment regimen to demonstrate median OS over one year in any phase III
trial of patients with advanced NSCLC.[4]
- These results demonstrate that Avastin is efficacious in patients with
advanced adenocarcinoma of the lung, showing a 3.9 month improvement in
OS over chemotherapy alone (14.2 months versus 10.3 months).[1]

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References

[1] Sandler A B, et al. Treatment outcomes by tumor histology in
Eastern Cooperative Oncology Group (ECOG) study E4599 of bevacizumab
with paclitaxel/carboplatin for advanced non-small cell lung cancer.
Journal of Thoracic Oncology, 5: early online, 03 August 2010.

[2] Alberg AJ, et al. Epidemiology of lung cancer. Chest
123:21S-49S, 2003.

[3] Govindan R, et al: Changing epidemiology of small cell lung
cancer in the United States over the last 30 years: Analysis of the
Surveillance, Epidemiology, and End Results database. J Clin Oncol
24: 4539-44, 2006.

[4] Sandler A, et al. Paclitaxel-Carboplatin Alone or with
Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med 355:
2542-50, 2006.

ots Originaltext: Roche Pharmaceuticals
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