imported_Joe
09-13-2005, 03:17 PM
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 (http://www.her2support.org/genfin.htm)
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
Joe
Final Results of BCIRG Herceptin Adjuvant Therapy Trials (http://www.her2support.org/genfin.htm)
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