Replies to post #69958 on Biotech Values

[DewDiligence]

Aromasin Not Statsig Better Than Tamoxifen at 2.75 Years

[These data from PFE make NVS’ Femara results in the same setting even more impressive. In the Aromasin trial in progress, the interim HR for DFS was 0.89 at 2.75 years; in the similar Femara trial, the HR for DFS was 0.79 at three years, when the trial was unblinded (#msg-34138469). In PFE’s favor, however, is the protocol change in 2004 to include treatment on Aromasin after progression in the Tamoxifen arm, which had the effect of damping the DFS outcome; this change was motivated by the Femara DFS results reported in 2003.]

http://news.yahoo.com/s/nm/20081211/hl_nm/us_pfizer_breast_1

›Thu Dec 11, 5:37 pm ET

NEW YORK (Reuters) – Pfizer Inc said on Thursday its Aromasin cancer drug was no better than tamoxifen at achieving disease-free survival after 2.75 years among postmenopausal women with hormone-sensitive early breast cancer.

Pfizer said the results were from a trial called TEAM designed to compare the two medicines over a period of 5 years.

Aromasin failed the first co-primary goal of the study by not extending the period of survival without progression of disease after 2.75 years. Some 9,775 patients, receiving either Aromasin or tamoxifen as initial therapy, were studied.

Although Aromasin was associated with an 11 percent reduction in risk of disease progression or death [i.e. HR=0.89]/i], the difference was not considered statistically significant. The results were presented at the San Antonio Breast Cancer Symposium, in Texas.

Data from a second planned analysis in the trial, of disease-free survival after five years of therapy, is expected in late 2009, Pfizer said.

Aromasin is a member of a class of drugs called aromatase inhibitors. It is currently approved among postmenopausal women with early breast cancer who have already used tamoxifen for two to three years, Pfizer said.

Tamoxifen is a SERM, or selective estrogen receptor modulator, that is available as a generic and used to treat both early and advanced breast cancer, and for prevention of breast cancer in women at high risk of developing the disease.‹