They enrolment rates, recurrence rates of controls at 18 and 24 months. Simple math. I would not be surprised if 70 th event happens Q2. The committee must now meet monthly, I suspect.
Who's he again? He failed. Study, unfortunately for the patients, failed. AF failed. I recommend you guys check the results of phase II studies and how unconvincing they were with more than half the patients in neuvax phase II trial. And how much the onco-financial twitters of this world pumped CLDX. This company was worth 2$B up unitl recently.
Should have been a thumbs up. My mistake.
We need a bit of meat at the next conference call.....accrual, interim?, abstract?
Since immune response take take to trigger and the fact that these medical researchers (Peoples, Mittendorf, et al.) decided to add a booster programme in their phase II trial is simply brilliant. It proved highly successful in phase II. If I'm not mistaken, all vaccine trials that have failed, failed to have a booster program. CLDX likely failed because of that. So did the recent three or four immunotherapy trials recently canned.
Actually, I think it's based on accrual rate and simple mathematics. I think patients accrued by march 2014 was approximately 300 patients.
But say for our own analysis, 500 plus patients were accrued by september 2014, according to published info.
Say 50/50 enrollment, which is highly the case, 250 patients at 20% recurrence at 24 months = 50 patients by September 2016. Say 10% recurrence for Neuvax = 10%X 250 = 25 patients...... Factor in a 2-5% dropout rate, I think that realistically, 70th event should be around june 2016.
True. And there will be recurrence in the remaining patients. Basically, we may have over estimated accrual. I could be wrong.
Anybody there that could give us a summary of her talk???
Fraud stein pumped a failed CLDX p.3 trial that was flawed as phase 2 controls were based on historical data. Moron. He could have simply done a medline search to see how the CLDX phase 2 data were simply flawed.
He's got zero credibility. Zero.
She's clearly optimistic.
Interview following Miami conference.
Very, very interesting. Check Video link
March 15, 2016 | MBCC 2016, Breast Cancer
By Elizabeth A. Mittendorf, MD, PhD
Cancer Network: How has being both a surgeon and immunologist, shaped your views of the potential clinical roles of cancer vaccines?
Dr. Mittendorf: As a surgeon, I see and treat patients with early-stage breast cancer that is potentially curable. Unfortunately, despite our best treatment—surgery, chemotherapy when indicated, radiation if required—we still see recurrences in up to 20% of these patients. I think it is not unreasonable to hypothesize that this recurrence is in part attributable to a failure of the immune response against the cancer—hence my enthusiasm for vaccines that could potentially augment that antitumor immunity, thereby decreasing the risk of recurrence.
Cancer Network: In what settings do breast cancer vaccines show the most promise?
Dr. Mittendorf: Secondary prevention. There is currently one vaccine that is being investigated in a phase III trial—NeuVax—which is made up of an immunogenic peptide combined with an immunoadjuvant. The trial is vaccinating patients in the adjuvant setting with the goal being to determine if vaccination can decrease the risk of recurrence.
Secondary prevention is the NEUVAX, PRESENT, phase III trial.
Dr. Mittendorf is the super-key investigator. Says tons of how well it will work.
Abstract Number: CT073
Presentation Title: Comparing an attenuated booster (E39’) vs E39 booster to potentiate the clinical benefit of the folate binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase I/IIa trial to prevent recurrence in endometrial (EC) and ovarian cancer (OC) patients
Presentation Time: Tuesday, Apr 19, 2016, 8:00 AM -12:00 PM
Trastuzumab increases uptake and cross-presentation of HER2-derived antigens by dendritic cells
Presentation Time: Sunday, Apr 17, 2016, 1:00 PM - 5:00 PM
Interesting. Somewhat strange that if 70th event to occur end of March, assessed by the central evaluating committee, say in April, data rolled up to independent committee in May, one day meeting, recommendation to GALE late May.....and only announced late June? Not sure what to make of it, but looks like a great sign to me
Means that the Independent data committee recommends to go forward with the trial as according to their statistical projections, study will meet primary end point.
Let's not minimize this outcome. Huge.
Also, despite the fact that the study has no stoppage rules at the interim point, the committee may recommend a halt for efficacy, especially if overall survival is skewed, and/or if the recurrence rate is extremely skewed in favour of neuvax. BUT, decision is to be taken by GALE only. That's when I would expect them to meet with FDA and discuss future plan of action.