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NeuVax, Prevention of Recurrence in Early-Stage, N

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math666 View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Topic: NeuVax, Prevention of Recurrence in Early-Stage, N
    Posted: Jan 08 2016 at 8:10am
Good Morning,
 
Has someone taken NeuVax + Herceptin to prevent recurrence?  
 
Thanks!
 
math666


Edited by math666 - Jun 02 2016 at 5:58am
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Post Options Post Options   Thanks (0) Thanks(0)   Quote unklez Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2016 at 7:35pm
Hello Math666,

I am not 100% sure and I am not a medical professional but I believe Herceptin is only used for HER2 Positive cancers, no?


Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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Post Options Post Options   Thanks (1) Thanks(1)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2016 at 10:31pm
Hello, unklez.
 
There is a clinic trial for triple negative patients with Her2 +  or ++ but FISH <= 2.2,.
------------------------------------------------------
 

MDACC Study No:

2013-0436 (clinicaltrials.gov NCT No: NCT01570036)

Title:

Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2- expressing breast cancer patients to prevent recurrence

Principal Investigator:

Elizabeth A. Mittendorf

Treatment Agent:

Herceptin; NeuVax

Study Status:

Open

Study Description:

The goal of this clinical research study is to learn if the HER2/neu vaccine
E75, when given in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Herceptin (trastuzumab), may help prevent breast cancer from coming back. The safety of this drug combination will also be studied.


Hide details for General InformationGeneral Information

Disease Group:

Breast

Phase of Study:

Phase II

Treatment Agents:

Herceptin
NeuVax

Treatment Location:

Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:

Supported By:

Cancer Insight, LLC
Galena Biopharma
Genentech, Inc.

Return Visit:

Home Care:



Hide details for Study Contact InformationStudy Contact Information

Physician Name:

Elizabeth A. Mittendorf

Dept:

Surgical Oncology

For Clinical Trial Enrollment:

713-792-6940

For General Questions about Clinical Trials:

1-877-MDA-6789



Hide details for Study Objectives / OutcomesStudy Objectives / Outcomes

PRIMARY OBJECTIVES

The primary efficacy endpoint is to compare disease-free survival (DFS) at 24 months between treatment groups. The primary safety issue is to prove there is no additive cardiac toxicity with combination HER2-directed therapy.

SECONDARY OBJECTIVES

A secondary endpoint of the trial is to compare DFS at 36 months. Immunologic responses to the vaccine will also be documented and correlated to clinical benefit.


Hide details for Study Status InformationStudy Status Information

Study Activation/Registration Date:

IRB Review and Approval Date:

09/11/2013

Study Type:

Phase Ii Or Phase I/Ii

Recruitment Status:

Open

Projected Accrual:

300



Hide details for Enrollment EligibilityEnrollment Eligibility

Inclusion Criteria:

1)     Women 18 years or older.

2) Node-positive breast cancer (American Joint Committee on Cancer [AJCC] N1, N2, or N3).

3) Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR) receptors and have received chemotherapy as standard of care.

4) Clinically cancer-free (no evidence of disease) after standard of care therapy (surgery, chemotherapy, radiation therapy as directed by National Comprehensive Cancer Network (NCCN) guidelines). Hormonal therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.

5) Recovery from any toxicity(ies) associated with prior adjuvant therapy.

6) HER2 expression of 1+ or 2+ by immunohistochemistry (IHC). Fluorescence in situ hybridization (FISH) testing must be performed on IHC 2+ tumors and shown to be non-amplified (</= 2.2).

7) Human leukocyte antigen (HLA)-A2 and/or HLA-A3 positive.

8) Left ventricular ejection fraction (LVEF) >/= 50%, or an LVEF within the normal limits of the institution’s specific testing (MUGA or Echocardiogram).

9) Eastern Cooperative Oncology Group (ECOG) 0,1.

10) Signed informed consent.

11) Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms).

 

Exclusion Criteria:

1) Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER) and progesterone (PR) receptors and has received chemotherapy as standard of care.

2) Clinical or radiographic evidence of distant or residual breast cancer.

3) HER2 negative (IHC 0) or HER2 3+ or FISH amplified (FISH > 2.2).

4) Non-HLA-A2/3 positivity.

5) History of prior Herceptin (trastuzumab) therapy.

6) NYHA stage 3 or 4 cardiac disease.

7) LVEF <50%, or less than the normal limits of the institution’s specific testing (MUGA or Echo).

8) Immune deficiency disease or HIV, HBV, HCV.

9) Receiving immunosuppressive therapy including chemotherapy, chronic steroids, methotrexate, or other known immunosuppressive agents.

10) ECOG >/= 2.

11) Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000.

12) Pregnancy (assessed by urine HCG).

13) Breast feeding.

14) History of autoimmune disease.

15) Active pulmonary disease requiring medication to include multiple inhalers.

16) Involved in other experimental protocols (except with permission of the other study PI).

 
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EmT View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote EmT Quote  Post ReplyReply Direct Link To This Post Posted: Mar 08 2016 at 4:39pm
Yes & I am very familiar with the trial mentioned by Math666
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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Mar 08 2016 at 5:33pm
unklez! Good to see you here!
   Thanks math666, I would've been with unklez on my answer.
But wait a minute, after reading the post doesn't it look like the ER/PR neg is ok but not the HER2 neg...doesn't that show as disqualifying?

Edited by mainsailset - Mar 08 2016 at 5:39pm
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Mar 29 2016 at 4:00pm

7:28 am Galena Biopharma phase 3 present clinical trial with Neuvax achieves 70 qualifying disease free survival events (GALE) :

PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is an international, Phase 3 study to evaluate NeuVax plus granulocyte macrophage-colony stimulating factor (GM-CSF) versus placebo plus GM-CSF to prevent cancer recurrence.

  • NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma
  • Based on clinical and radiological data, seventy qualifying DFS events have been confirmed by the trial's independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. In the ensuing months, Galena will compile and submit the clinical data to the trial's Independent Data Monitoring Committee (:IDMC) to perform the Interim Analysis. The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial
  • Dr. Nejadnik continued, "The 70th event also represents a significant maturation of the program and is a meaningful time point as it brings us halfway to the full number of 141 events required for the primary endpoint analysis in conjunction with three years minimum follow-up."

http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#gale

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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 01 2016 at 11:19am
NOTE:   Many triple negative patients with Her2 +  or ++ but FISH <= 2.2.


Galena Biopharma Receives Fast Track Designation for NeuVax™ (nelipepimut-S) PRESENT Clinical Trial

SAN RAMON, Calif., June 01, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has designated NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena’s PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.

“This Fast Track designation by the FDA reflects the importance of NeuVax as a potential treatment option addressing an unmet medical need in a serious medical condition,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  “With the number of cancer survivors in the United States projected to increase by 31% to almost 19 million by 20241, there is a clear need to prevent recurrence in women with breast cancer who have completed their standard of care, but have limited therapies to maintain their disease free status.  As we approach our interim safety and futility analysis for PRESENT, and initiate our efforts towards the filing of a Biologics License Application (BLA), this Fast Track designation will be extremely valuable to us as we seek marketing authorization for NeuVax.”

“Fast Track designation provides us with opportunities for frequent interactions with the FDA review team for our NeuVax development program in breast cancer, including the PRESENT trial, as we prepare our BLA for filing. As such, assuming a successful clinical readout in the PRESENT trial, we may be eligible for a rolling review. We look forward to collaborating closely with the FDA at this critical stage for NeuVax development,” added Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer.

The Fast Track designation provides for the designation of a drug as a fast track product if it is intended for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.2 This designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.3 Designation as a Fast Track product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application (rolling review).4 In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA submission.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Oct 19 2016 at 11:47am
Has someone still in NeuVax clinic trial for preventing recurrence?  Thanks!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote strongtogether Quote  Post ReplyReply Direct Link To This Post Posted: Nov 19 2019 at 1:16am
Originally posted by math666 math666 wrote:

Has someone still in NeuVax clinic trial for preventing recurrence?  Thanks!

 I'd love to know the answer to this. Are there any people still on a Neuvax trial?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Nov 19 2019 at 8:06am
I believe this trial was for Er, Pr negative and low to intermediate Her2+ only.  (Criteria:HER2 expression of 1+ or 2+ by immunohistochemistry (IHC)).  The vaccine was combined with Herceptin for the trial.


**************************************************************************************************

Vaccine Prolongs Remission in Triple-Negative Breast Cancer

Treatment with a novel peptide vaccine appeared to delay disease recurrence in triple-negative breast cancer (TNBC) patients with low HER2 expression, a subgroup analysis of a phase II trial found.

At a median follow-up of 26.1 months, disease recurrence occurred in 7.5% of TNBC patients who received nelipepimut-S (NeuVax) compared with 26.7% in the control arm (HR 0.26, 95% CI 0.08-0.81, P=0.01), reported Guy T. Clifton, MD, of San Antonio Military Medical Center in Texas. . . .

. . .

Clifton concluded that the combination is safe, added no cardiac toxicity, and "may provide benefit for patients with HER2-low expressing triple-negative breast cancer," but said this would need to be confirmed in a phase III trial, which is being pursued.

"Our approach has been to use this in the adjuvant setting, in patients who are clinically disease free," he said. "It avoids immunosuppression associated with patients who are metastatic, but also avoids the tumor suppressive microenvironment associated with established tumors."

"This is really an immuno-prevention trial, where you're trying to do a secondary prevention," said discussant Kunle Odunsi, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, New York. "Therefore the type of T cells that you need to generate ideally should have memory attributes or even those stem cell attributes."

He said that strengths of the study include the "very robust" preclinical rationale for the vaccine's efficacy in this setting, use of a shared antigen allowing for ease of production and availability, and the broad patient group -- patients had to be clinically disease free following standard therapies and positive for HLA-A2, A3, A24, or A26. During screening, only 17% were excluded for HLA status.

Odunsi noted that the effect observed in the TNBC group appears to be "clinically meaningful," but also questioned whether the study was powered for such a subgroup analysis and whether GM-CSF is the most appropriate adjuvant.

From 2013 to 2018 the trial enrolled high-risk, invasive breast cancer patients with HER2 expression levels of 1-2 on immunohistochemical staining, across 26 U.S. centers. High-risk was defined as node-positive, regardless of hormone receptor status, or node-negative for TNBC patients.

Patients were well-matched for stage, said Clifton, and a little over half of patients in each arm received neoadjuvant chemotherapy. . . .

To read the entire article:
https://www.medpagetoday.com/meetingcoverage/additionalmeetings/78441









Edited by 123Donna - Nov 19 2019 at 8:14am
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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