HER2 Support Group Forums - View Single Post - New Vaccine Trials for Metastatic Breast Cancer

'lizbeth · 08-23-2013, 11:17 AM

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. 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?

08-23-2013, 11:17 AM	#4
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	Re: New Vaccine Trials for Metastatic Breast Cancer 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. 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?