NeuVax (nelipepimut-S) / Dr. Reddy’s 
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  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    P2 data, Journal:  Phase II Trial of Nelipepimut-S Peptide Vaccine in Women with Ductal Carcinoma In Situ. (Pubmed Central) -  Jun 5, 2023   
    This trial showed that vaccination of patients with HLA-A2-positive DCIS with NeuVax in the preoperative setting can induce a sustained antigen-specific T-cell response. This provides proof of principle that vaccination in the preoperative or adjuvant setting may stimulate an adaptive immune response that could potentially prevent disease recurrence.
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Enrollment change:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  May 16, 2023   
    P2,  N=43, Active, not recruiting, 
    Caution is required when associating radiation with TKI and antibody drugs, considering the limited evidence. N=13 --> 43
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    P2 data, Journal:  Phase II Trial of Nelipepimut-S Peptide Vaccine in Women with Ductal Carcinoma in Situ. (Pubmed Central) -  May 15, 2023   
    NPS+GM-CSF is safe and well-tolerated when given preoperatively to DCIS patients. In HLA-A2-positive DCIS patients, two inoculations with NPS+GM-CSF can induce in vivo immunity and a continued antigen-specific T-cell response one-month post-surgery.
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    P2 data, Journal:  Phase II Trial of Nelipepimut-S Peptide Vaccine in Women with Ductal Carcinoma In Situ. (Pubmed Central) -  May 11, 2023   
    This trial showed that vaccination of patients with HLA-A2-positive DCIS with NeuVax in the preoperative setting can induce a sustained antigen-specific T-cell response. This provides proof of principle that vaccination in the preoperative or adjuvant setting may stimulate an adaptive immune response that could potentially prevent disease recurrence.
  • ||||||||||  Journal:  Immunotherapy for the Breast Cancer treatment: Current Evidence and Therapeutic Options. (Pubmed Central) -  Apr 13, 2022   
    Immune checkpoint inhibitors (anti-PD-1/ anti-CTLA-4) and anti-cancer vaccines (NeuVax, Muc-1, AVX901, INO-1400 and CEA), either alone or in combination with other therapies have created new paradigm in therapeutic world. In this review, we highlighted the current immunotherapeutic aspects and their ongoing trials towards the better treatment regimen for BC.
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Trial completion date, Trial primary completion date:  Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (clinicaltrials.gov) -  Apr 26, 2021   
    P2,  N=100, Active, not recruiting, 
    The observed benefit to this high-risk subgroup warrants confirmation in a phase III trial. Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021
  • ||||||||||  NeuVax (nelipepimut-S) / SELLAS Life Sciences
    [VIRTUAL] Vadis trial: phase II trial of Nelipepimut-S peptide vaccine in women with DCIS of the breast (Channel 1) -  Oct 2, 2020 - Abstract #SABCS2020SABCS_1274;    
    In HLA-A2 positive patients with DCIS, a single inoculation with NPS+GM-CSF can induce in vivo immunity and a continued antigen-specific T-cell response one month post-surgery. This data provides support for further testing of NPS+GM-CSF in the neoadjuvant and adjuvant settings in an attempt to prevent invasive recurrence in DCIS.
  • ||||||||||  NeuVax (nelipepimut-S) / SELLAS Life Sciences
    Journal:  Towards Breast Cancer Vaccines, Progress and Challenges. (Pubmed Central) -  Sep 5, 2020   
    One breast cancer vaccine (NeuVax) has now completed clinical trial phase III and a few preventive and therapeutic breast cancer vaccines are at different steps of development. We think that with the recent advancements in immunotherapy a breast cancer vaccine is not far from reach.
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy’s
    Review, Journal:  Evaluating Nelipepimut-S in the Treatment of Breast Cancer: A Short Report on the Emerging Data. (Pubmed Central) -  Apr 21, 2020   
    The current leading peptide vaccine for human application is a HER2-based vaccine known as Nelipepimut-S, which has demonstrated immune activity and promising clinical activity in some settings. This review covers the development of this newer peptide vaccine for both HER2 amplified and non-amplified breast cancer.
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    Phase classification:  Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer (clinicaltrials.gov) -  Mar 31, 2020   
    P1,  N=95, Completed, 
    This review covers the development of this newer peptide vaccine for both HER2 amplified and non-amplified breast cancer. Phase classification: P1/2 --> P1
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Enrollment change:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Jul 18, 2019   
    P2,  N=13, Active, not recruiting, 
    The clinical efficacy of this combination will be reported 6 months after the final patient was enrolled. N=108 --> 13
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Trial primary completion date:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Mar 12, 2019   
    P2,  N=108, Active, not recruiting, 
    Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Dec 2019 --> Mar 2021 Trial primary completion date: Mar 2019 --> Aug 2019
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Enrollment closed, Trial primary completion date:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Feb 22, 2019   
    P2,  N=108, Active, not recruiting, 
    Trial primary completion date: Mar 2019 --> Aug 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2019 --> Mar 2019
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Trial completion, Trial completion date, Trial primary completion date:  Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax (clinicaltrials.gov) -  Nov 27, 2018   
    P2,  N=300, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Sep 2018 | Trial primary completion date: Jun 2019 --> Sep 2018
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Trial primary completion date:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Aug 7, 2018   
    P2,  N=108, Recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Sep 2018 | Trial primary completion date: Jun 2019 --> Sep 2018 Trial primary completion date: Mar 2019 --> Sep 2019
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Enrollment closed:  Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax (clinicaltrials.gov) -  Apr 6, 2018   
    P2,  N=300, Active, not recruiting, 
    Trial primary completion date: Mar 2019 --> Sep 2019 Recruiting --> Active, not recruiting
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Trial primary completion date:  Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax (clinicaltrials.gov) -  Apr 7, 2017   
    P2,  N=300, Recruiting, 
    Recruiting --> Active, not recruiting Trial primary completion date: Dec 2017 --> Jun 2019
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    Trial completion, Trial primary completion date:  PRESENT: Efficacy and Safety Study of NeuVax (clinicaltrials.gov) -  Feb 24, 2017   
    P3,  N=700, Completed, 
    Trial primary completion date: Oct 2018 --> Dec 2019 Active, not recruiting --> Completed | Trial primary completion date: Apr 2018 --> Sep 2016
  • ||||||||||  NeuVax (nelipepimut-S) / SELLAS Life Sciences, Herceptin (trastuzumab) / Roche
    Journal:  Effect of novel peptide vaccines on secondary recurrences and survivorship. (Pubmed Central) -  Feb 3, 2017   
    P1
    Nelipepimut-S is currently being investigated in three ongoing adjuvant clinical trials - 1) single agent in a registrational Phase 3, PRESENT, under a FDA-approved SPA; 2) combination with trastuzumab in IHC 1+/2+ and IHC 3+. Early results of E39 are encouraging and a Phase 2b is being planned in gynecological malignancies.
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Trial primary completion date:  Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax (clinicaltrials.gov) -  Jan 4, 2017   
    P2,  N=300, Recruiting, 
    Early results of E39 are encouraging and a Phase 2b is being planned in gynecological malignancies. Trial primary completion date: Dec 2016 --> Dec 2017
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    Enrollment open, Trial initiation date, Trial primary completion date, IO biomarker:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Jun 29, 2016   
    P2,  N=108, Recruiting, 
    Recruiting --> Suspended Not yet recruiting --> Recruiting | Initiation date: Mar 2016 --> Jun 2016 | Trial primary completion date: Sep 2019 --> Mar 2019
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's
    New P2 trial, IO biomarker:  VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) -  Dec 22, 2015   
    P2,  N=108, Not yet recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Mar 2016 --> Jun 2016 | Trial primary completion date: Sep 2019 --> Mar 2019 .
  • ||||||||||  Leukine (sargramostim) / Partner Therap, NeuVax (nelipepimut-S) / Dr. Reddy's, Herceptin (trastuzumab) / Roche
    Trial primary completion date:  Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax (clinicaltrials.gov) -  Nov 22, 2015   
    P2,  N=300, Recruiting, 
    . Trial primary completion date: Dec 2015 --> Dec 2016
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    Enrollment closed, Trial primary completion date:  PRESENT: Efficacy and Safety Study of NeuVax (clinicaltrials.gov) -  Apr 15, 2015   
    P3,  N=700, Active, not recruiting, 
    Trial primary completion date: Dec 2015 --> Dec 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2017 --> Apr 2018
  • ||||||||||  NeuVax (nelipepimut-S) / Dr. Reddy's
    Trial primary completion date:  Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer (clinicaltrials.gov) -  Jun 1, 2014   
    P1/2,  N=95, Completed, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2017 --> Apr 2018 Trial primary completion date: Dec 2007 --> May 2012