Genentech Announces Results of Adjuvant Trials

I received this about an hour ago. I would expect Roche to announce the results of their worldwide HERA trials shortly.

Joe

Final Results of BCIRG Herceptin Adjuvant Therapy Trials

Dear Advocates,

The Breast Cancer International Research Group (BCIRG), Sanofi-Aventis and Genentech today announced the results of a planned interim analysis of a Phase III trial of Herceptin in the adjuvant setting, which demonstrated a significant improvement in disease-free survival in women with early stage HER2 positive breast cancer. The arms of the study were as follows:

Arm 1 (control)
doxorubicin and cyclophosphamide (AC) --->Taxotere (T)
n=1043

Arm 2
AC-->T + Herceptin (H)
n=1072

Arm 3
T + carboplatin © + H
n=1056

The reduction in the risk of disease recurrence, the primary endpoint of the study, was 51 percent (95 percent confidence interval of 35 percent to 63 percent) in Arm 2 where Herceptin was added to Taxotere following AC and 39 percent (95 percent confidence interval of 21 percent to 53 percent) in Arm 3 (TCH). Since this is a planned interim analysis, the data is not mature enough to support a comparison of the efficacy of Arm 2 vs. Arm 3. In addition, there is not enough data to evaluate the secondary endpoint of overall survival. Adverse events in the BCIRG study were consistent with those seen in previous clinical trials of Herceptin. The rate of clinically significant cardiac events, including congestive heart failure (weakening of the heart muscle), in the TCH arm was the same as the AC/Taxotere arm (1.2 percent in each arm). Cardiac events occurred at a rate of 2.3 percent in the AC/Taxotere/Herceptin arm. The BCIRG study was sponsored by Sanofi-Aventis and Genentech. Please find the press release attached for your review.

I will be scheduling a conference call in the coming weeks for you and our Clinical team to review the BCIRG interim analysis and discuss concerns/questions on this study or the other Herceptin studies.

Also, it has come to my attention that there is some confusion around the Dear Healthcare Provider Letter, distributed on August 30, about the cardiotoxicity risk for adjuvant use of Herceptin. It is important to know that these safety data were presented at ASCO and are consistent with those previously reported in Herceptin clinical trials in women with metastatic breast cancer and are described in the current label. We voluntarily approached the FDA about issuing the letter to ensure that healthcare providers have this important safety information, as well as the eligibility and cardiac monitoring guidelines under which the trials were conducted. We can address additional questions or concerns about cardiotoxicity with Herceptin on the upcoming teleconference.

I look forward to speaking with you soon. As always, feel free to contact me in the meantime if you have immediate questions or concerns.

Best regards,
Ajanta

Now, if they can answer the question of overall survival... that would be the best news yet if it gets this kind of % improvement.

Dear Joe,
I was in the 3rd arm. ACT and in the background of the information sheet on that particular study, it just said it showed promise. Can they at least give us some clue as to what that promise was? Do we really have to wait until 2006 to find out the results of the 3rd arm? Can we assume that we are at least within the 50% reduction rate or are we more or less?
Sorry if I sound whinny, I am not. I am just very glad I got Herceptin when it wasn't approved. If you can find out anything myself and others in that arm would be greatly apprectiative. Thanks for all you and Christine do. LOL k

OPPS!!
I was the 3rd arm, chemo brain here. I got Carbo, Taxotere and Herceptin, don't know how ACT got typed in there? Sorry./ k

Kristen,

The third also showed 39% decrease in recurrence. Wonderful news.

At long last. This is great news. I was in th AC TH arm of this trial. I would love to know what this really means in common language. Do you know what percent in each arm is still disease free or what percent had a relapse. It is so hard to understand how they present it. Will we be able to sit in on the conference call?
Thanks for everything Joe.
Diane