New Vaccine Trials for Metastatic Breast Cancer

[Mtngrl]

The other day MedPage Today had an article on novel immune therapies for metastatic breast cancer. I was particularly intrigued by the one that is designed for HER-2 cancers (not just in the breast) that involves a custom-made vaccine from the patient's own tissues.

I told my oncologist I'm still interested in doing a vaccine trial, and she replied that the HER-2 study is being done where I get treated. She said they use tumor tissue to generate the vaccine. I have never had surgery, so if she means live tissue from the original tumor, I can do that. She asked me if I wanted to talk to the study folks and I said yes.

Here's how the article describes it:
An NCI-sponsored MBC trial is testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize human epidermal growth factor receptor 2 (HER2).3 The vaccine, called AdHER2/neu dendritic cell vaccine, is custom-made using an individual patient's own immune cells. This 1-year, phase I trial will determine the immunogenicity related to anti-HER2/neu antibody concentrations and the impact of the autologous AdHER2 dendritic cell vaccine on tumor growth and regression rates, disease status, and vaccine-induced antibody profiles. The vaccine is being studied in HER2-positive breast cancer as well as other types of HER2-positive solid tumors.
Here's the link: http://www.medpagetoday.com/resource-center/metastatic-breast-cancer/vaccines/a/37065?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2013-08-21&eun=g398260d0r&userid=398260&email=amy.west@durfeewest.com&mu_id=5390856

I'll keep you posted.

[jacqueline1102]

Thanks so much for this, Amy. Hope you are well. I always enjoy reading your posts.

Take care,

Jackie

[Rolepaul]

http://regulatoryaffairs.pharmaceutical-business-review.com/news/galena-announces-european-patent-notification-for-pharmaceutical-use-of-neuvax-220813
Another vaccine that was approved in Europe.

['lizbeth]

Amy,

I am so pleased that you are considering a dendritic vaccine trial. I had the impression that it was created from a blood draw, not the tumor tissue. So am quite curious to learn how the vaccine actually works.

I'm really excited that this is available for stage IV. I hope that you find it is perfect for you, and it takes out those pesky cancer cells cold with minimal side effects.

@RolePaul - I thought the same at first. This is one of the vaccines I follow closely because I know some of the clinical trial doctors and nurse from my own treatments. I see Galena Biopharma received a patent, expanding intellectual property which I believe is different than a drug approval.

Neuvax is in Phase III trials in the US. The PRESENT trial for low and intermediate expressors: Her2 1+ and Her2 2+. It has also entered a Phase IIb trial with Herceptin and Neuvax for the low and intermediate expressors.

Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com (http://www.neuvax.com). A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin(R) (trastuzumab; Genentech/Roche).

I personally hope that we high expressors will be included in the final drug approval. But I do not see clinical trials for the HER2 3+ with the vaccines I follow. There is some enrollment is specific locations for the Phase IIa AE37 clinical trial, which is a second generation vaccine after Neuvax. But I expect AE37 to switch to the larger market of low and intermediate expressors.

I am not that familiar with the FDA approval process, but am starting to feel that I was lucky enough to receive a vaccine. But will other Her2 3+ survivors miss out because the market is too small?