NeuVax breast cancer vaccine tested .......

cp418

NeuVax breast cancer vaccine tested at Memorial Regional Cancer Center

http://www.wndu.com/content/news/NeuVax-Breast-Can...

mike3121

NeuVax is only for Her2+ right?

farmerlucy

very exciting!

cp418

mike - yes, for Her2+. Lots of vaccine research on TNBC and Her2+. We also need vaccine research for HR+, Her2 neg patients who develop drug resistance and are high risk for later recurrence. Vaccine for mets to stabalize patients and arrest progression would be better than winning the lottery IMO.

toomuch

Mike - There are at least 2 Neuvax trials. One enrolls women who are Her2 low, 1+ or 2+ positive, but considered Her2 negative for treatment. So, you can be considered Her2 negative and be enrolled in a vaccine trial.

wallycat

I'm wondering how this would apply to Her3+ in ILC sub-types....don't know enough about any of it to date.

Hopeful82014

As toomuch stated, NeuVax is NOT for her2 only, by any means. The confusion may arise because one clinical trial is studying the effect of treatment with both Herceptin and NeuVAx for high risk, low-intermediate Her2 expressing patients. Her2+ patients are specifically excluded from that trial. I believe there is another trial in Phase 3 without the Herceptin component.

JohnSmith

@Hopeful, which trial are you doing?

Vaccines across all cancer types have struggled in the last few years, especially when compared to the great strides made with immune checkpoint inhibitors and the promise of CAR-T / engineered T-cell receptor approaches. The real payoff will likely be when combining vaccines with these other immunotherapy approaches.
NeuVax is interesting though. I seriously hope it works since breast cancer needs to the lose the "nonimmunogenic" reputation.
With over 700 patients, the "PRESENT" clinical trial is the most significant, since it's a Phase III trial. (first one below)

Here's a short video from March 2016 where Dr. Elizabeth Mittendorf (MD Anderson) discusses NeuVax in relation to finding biomarkers of response.

Here's a simple breakdown of the four NeuVax vaccine clinical trials:

1. Prevention of Recurrence in Early-Stage, Node-Positive patients with Low to Intermediate HER2 Expressions With NeuVax Treatment (PRESENT trial)
Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: April 2025
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
UPDATE - June 29, 2016: Trial has been cancelled. NeuVax was unable to prevent recurrence in this clinical trial.
Source: Galena website - https://globenewswire.com/news-release/2016/06/29/852251/0/en/Galena-Biopharma-Discontinues-NeuVax-nelipepimut-S-Phase-3-PRESENT-Interim-Analysis-based-on-Independent-Data-Monitoring-Committee-Recommendation.html

2. Phase II Trial of Combination Immunotherapy with Nelipepimut-S + GM-CSF (NeuVax) and Herceptin in High-risk HER2+ Patients
Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

3. Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Patients to Prevent Recurrence
Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

* Target population: Node-positive (or Node-negative, if both ER- and PR-) patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy

4. Phase II Trial of Nelipepimut-S Peptide Vaccine in women with DCIS (VADIS Trial)
Estimated Enrollment: 108
Study Start Date: March 2016
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Hopeful82014

John, I'm in the third one on your list.

JohnSmith

Breaking news released today.

The NeuVax Phase 3 clinical trial (PRESENT) has been stopped (cancelled). NeuVax was unable to prevent recurrence in this clinical trial.
The Independent Data Monitoring Committee (IDMC) recommended that the PRESENT clinical trial be stopped due to futility.

I'm not sure how this affects the other three trials, but it might be wise to check in with your Oncologist ASAP.

Source: Galena website - https://globenewswire.com/news-release/2016/06/29/852251/0/en/Galena-Biopharma-Discontinues-NeuVax-nelipepimut-S-Phase-3-PRESENT-Interim-Analysis-based-on-Independent-Data-Monitoring-Committee-Recommendation.html

This is a monumental disappointment.

Hopeful82014

John, this is disappointing but does not apply at this time to the NeuVax plus Herceptin trial, which is the one in which I'm enrolled. I've put in a call to my study coordinator for more info.

FWIW, I think this is the trial for which I just missed the enrollment cut off date, which led me to the one I'm in.

If I hear anything useful from our study coordinator I'll pass it on.

muska

Wasn't it fast tracked by FDA just a few weeks ago based on preliminary results? How can it be fast tracked and then cancelled three or four weeks later?

Hopeful82014

Muska, it may have been one of the other therapy trials involving NeuVax - i.e., NeuVax plus Herceptin - that was fast-tracked.

muska

Hi Hopeful, on June 1 Galena posted the news about fast track designation for NeuVax PRESENT Clinical Trial, i.e. the trial that was cancelled today:

Fast Track for NewVax PRESENT Trial

ErenTo

I'd tried to get on this trial but mised the cut off date as well. I've been watching this since and also heard about it being fast tracked, so now this doesn't make sense.

Hopeful82014

You're absolutely correct, Muska; that is the same trial that was cancelled today. As ErenTo stated, this does not make any sense at all. I'm really curious to hear what our study coordinators come up with. Although they're not involved in this particular NeuVax trial they're pretty well in the loop as far as all of the various NeuVax trials.

muska

I don't know much about clinical trials but I suppose PRESENT's clinical data should have been analyzed in order to get fast tracked by FDA and that would be the same clinical data that prompted the Independent Data Monitoring Committee (IDMC) to recommend that the PRESENT trial be stopped due to futility.

Maybe somebody with more knowledge can comment on this but from a patient perspective I would be very hesitant to consider any trials until I am in a really dire situation and have nothing to lose. I am now reading that Phase II results didn't show any benefits to begin with.

ErenTo

muska, I think you're right. I still don't understand how they could get approval from FDA to fast track this before IDMC's analysis and recommendation was finalized. Some people must have made a lot of money with buying and selling Galena shares within the right window...

My search leads me to mostly investment sites who were watching this drug. I came across this one which is not only disappointing, but also scary.

The IDMC, after evaluating interim data from the Phase 3 program (the PRESENT study), determined that the breast cancer vaccine was ineffective at stopping the resurgence of tumors compared to the placebo group. The committee's short letter to Galena in regards to the futility of NeuVax as a cancer treatment actually suggests that the drug might have performed worse than the placebo during the trial.

http://www.economiccalendar.com/2016/06/30/galena-...

Also from the link:

It appeared as though NeuVax did not respond to cancer cells with high expression levels of HER2 – but worked best against those with low-to-intermediate levels of HER2.

I thought PRESENT trial was for low to intermediate HER2 expression? Not sure I'm very clear on this. Granted it's not a scientific writing, I'd be curious what the data looked like.

muska

Eren, I agree. I did a quick research about Galena and very quickly came across this recent court decision: Galena Stock Touting.

Here's another link that has some interesting info about insider trading when the stock was at its peak: Insider Trading

ErenTo

Interesting stuff. I like to know how their other trials are going, hope they're more promising than this one