Onyx and Bayer (
BAY.DE) presented data from their collaborative Phase 2 study of Nexavar. Clinical data presented by Onyx and Bayer show Nexavar may help breast cancer drugs work longer by circumventing the mechanism used by the cancer to resist the effects of the aromatase inhibitors. In this study, Nexavar was given to 35 post-menopausal women with advanced breast cancer resistant to treatment with aromatase inhibitors. All of the patients had disease progression and the researchers found that twenty-three percent of the women in the study experienced clinical benefit. This means they either had shrinkage of their tumors or the disease stayed stable. Onyx and Bayer are planning a Phase III study to further explore the clinical benefit of Nexavar. Read more about these findings
here.
An abundance of the research presented at the SABCS revolved around Genentech's (
DNA) blockbuster monoclonal antibody trastuzumab (Herceptin) and HER2+ over-expression. HER2 protein over-expression affects approximately 20% to 30% of breast cancer patients. Many studies in this area were provided for combination therapies utilizing trastuzumab. These studies include GlaxoSmithKline's (
GSK) Tykerb which showed that women with metastatic breast cancer treated with a combination of Tykerb and trastuzumab experienced a
median overall survival of 14 months compared with 9.5 months for those given Tykerb as a monotherapy. Read more about this story
here.
Not to be outdone, Genentech (
DNA) and ImmunoGen (
IMGN) announced positive Phase II clinical data for their next generation candidate trastuzumab-DM1 or T-DM1. T-DM1 comprises ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting trastuzumab. This Phase II study found that
T-DM1 achieved a 32.7 percent response rate among the 110 enrolled patient that have advanced (metastatic) HER2-positive breast cancer. Read more about this story
here.
The United States Military Cancer Institute and Antigen Express, a wholly owned subsidiary of Generex Biotechnolgy (
GNBT), presented positive data from an ongoing Phase II trial of the AE37 HER2/Neu peptide vaccine. As I mentioned in my blog last year detailing findings at SABCS 2008,
Genentech and Generex: New HER2/neu Research, while the target of AE37 is the same as trastuzumab, an advantage of using this type of active immunotherapy is that activated immune cells can detect and destroy cancer cells expressing much lower levels of HER-2/neu than is needed for recognition by trastuzumab. Only 25% of breast cancers have levels of HER-2/neu expression high enough to be candidates for trastuzumab related treatment, yet 75% of patients with breast cancer show some level of HER-2/neu expression in their tumors. All 75% of these patients are expected to be good candidates for active immunotherapy as is being pursued at Antigen Express.
The Phase II interim data reported by the USMCI Clinical Trials Group for the AE37 vaccine included 120 of a planned 200 breast cancer patients who are currently disease free but have a high risk for recurrence. DTH reactions to AE37 increased significantly from baseline at 1 month after completion of the primary series and the vaccine was well tolerated with no grade 4-5 local toxicities and no grade 3-5 systemic toxicities. (This is in stark contrast to the ill effects of many other cancer drugs in development or that are currently approved.)
At a median follow up of 13 months, there have been no (0.0%) recurrences in the patients receiving the AE37 vaccine (0/49) compared to 7.0% (5/71) in the control group (p=0.08). The authors conclude their remarks by stating the AE37 peptide vaccine may protect against breast cancer recurrences.
The endpoint for this efficacy study is a 50% reduction in the rate of relapse of disease at two years, so they are entering the critical months before a final conclusion may be attained. Continued success for AE37 in treating patients before they succumb to metastatic breast cancer will enable them to live longer, healthier lives and guard them from needing the other more costly and toxic drugs in development mentioned above. A goal of the USMCI and Antigen Express is to allow the cancer patients to live out full lives, rather than a focus on extending the final stages of disease by a few months. Learn more about the AE37 Ii-Key hybrid technology of Antigen Express
here and their collaboration with the USMCI
here.
All of the research presented at SABCS 2009 is needed and valuable. Breast cancer is the second-leading cause of cancer death among U.S. women. This is a very small sampling of the promising research that was presented at this high profile event. The many promising abstracts and posters presented at SABCS 2009 can be found at their main website by clicking
here. Simply navigate to the poster and abstract links and accept the terms as a guest. You can find the studies listed above by putting the drug name, ie AE37, in the search bar.
Regards
Joe
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