Stimuvax (tecemotide) / EMD Serono, Ono Pharma 
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  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Review, Journal:  Liposomal formulations for lung cancer treatment in the last two decades: a systematic review. (Pubmed Central) -  Aug 7, 2022   
    This systematic review (registration number CRD42021246587) demonstrates that liposomal formulations are promising alternatives to overcome limitations of traditional cancer therapy. However, larger, longer, randomized and double-blinded clinical trials, selecting their patients' cohort considering more responsive subgroups would be beneficial to strengthen the scientific and clinical evidence of the results herein reported.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Clinical, Journal:  Survival after secondary liver resection in metastatic colorectal cancer: Comparing data of three prospective randomized European trials (LICC, CELIM, FIRE-3). (Pubmed Central) -  Feb 25, 2022   
    The objective of this analysis was to compare these favorable outcome data with recent results from the LICC trial investigating the antigen-specific cancer vaccine tecemotide (L-BLP25) as adjuvant therapy in mCRC patients with LLD after R0/R1 resection...Secondarily resected patients of LICC, CELIM and FIRE-3 showed an impressive median survival with a tendency for improved survival for patients in the LICC trial. A younger patient cohort but also more selective surgery, improved resection techniques, deep responses and a close surveillance program after surgery in the LICC trial may have had a positive impact on survival.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Review, Journal, Checkpoint inhibition:  Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. (Pubmed Central) -  Jan 7, 2022   
    The immunological interventions were active immunotherapy Bacillus Calmette-Guérin (BCG) adoptive cell transfer (i.e. transfer factor (TF), tumour-infiltrating lymphocytes (TIL), dendritic cell/cytokine-induced killer (DC/CIK), antigen-specific cancer vaccines (melanoma-associated antigen 3 (MAGE-A3) and L-BLP25), and targeted natural killer (NK) cells...Two trials provided health-related quality of life results with contradicting results.  AUTHORS' Based on this updated review, the current literature does not provide evidence that suggests a survival benefit from adding immunotherapy (excluding checkpoint inhibitors) to conventional curative surgery or radiotherapy, for people with localised NSCLC (stages I to III). Several ongoing trials with immune checkpoints inhibitors (PD-1/PD-L1) might bring new insights into the role of immunotherapy for people with stages I to III NSCLC.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Seattle Genetics, cyclophosphamide intravenous / Generic mfg.
    Clinical, P2 data, Journal:  Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC). (Pubmed Central) -  Sep 16, 2020   
    P2
    MUC1 expression was not associated with outcome.EudraCT No: 2011-000218-20Clinical Trial Information: NCT01462513Financial Support: Merck KGaA, Darmstadt, Germany. AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca, BMS, Stimuvax (tecemotide) / EMD Serono, Seattle Genetics
    Journal:  Role of immunotherapy in stage III nonsmall cell lung cancer. (Pubmed Central) -  Feb 14, 2020   
    PACIFIC trial results are expected to definitely establish durvalumab as standard consolidation strategy in LA-NSCLC. Many clinical trials are ongoing in the field of immunoradiotherapy in LA-NSCLC to define the optimal conditions for this therapeutic combination.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    New P2 trial, MSi-H Biomarker, IO biomarker:  SPRINT: Tecemotide (L-BLP25) in Rectal Cancer (clinicaltrials.gov) -  Jan 3, 2019   
    P2,  N=124, Active, not recruiting, 
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial completion, Trial completion date:  L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases (clinicaltrials.gov) -  Feb 13, 2018   
    P2,  N=122, Completed, 
    Many clinical trials are ongoing in the field of immunoradiotherapy in LA-NSCLC to define the optimal conditions for this therapeutic combination. Active, not recruiting --> Completed | Trial completion date: Jan 2018 --> Jan 2018
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial completion, Combination therapy:  EMR 63325-015: Tecemotide (L-BLP25) in Prostate Cancer (clinicaltrials.gov) -  Feb 16, 2017   
    P2,  N=28, Completed, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2016 --> May 2017 Active, not recruiting --> Completed
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial termination, Trial primary completion date:  START2: Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer (clinicaltrials.gov) -  Oct 23, 2015   
    P3,  N=35, Terminated, 
    Active, not recruiting --> Completed Active, not recruiting --> Terminated | Trial primary completion date: Jul 2018 --> Jul 2015; The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment change, Trial termination, Trial primary completion date:  INSPIRE: Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population (clinicaltrials.gov) -  Sep 4, 2015   
    P3,  N=285, Terminated, 
    Active, not recruiting --> Terminated | Trial primary completion date: Jul 2018 --> Jul 2015; The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC N=40 --> 285 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2015 --> Jun 2015; The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial termination:  EMR 63325-011: Common Safety Follow-up Trial of Tecemotide (L-BLP25) (clinicaltrials.gov) -  Aug 14, 2015   
    P=N/A,  N=20, Terminated, 
    Trial primary completion date: Sep 2009 --> Sep 2007 Active, not recruiting --> Terminated; The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial completion, MSi-H Biomarker, IO biomarker:  SPRINT: Tecemotide (L-BLP25) in Rectal Cancer (clinicaltrials.gov) -  Aug 12, 2015   
    P2,  N=124, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy:  EMR 63325-015: Tecemotide (L-BLP25) in Prostate Cancer (clinicaltrials.gov) -  Feb 20, 2015   
    P2,  N=28, Active, not recruiting, 
    N=159 --> 122 | Trial primary completion date: Sep 2016 --> Dec 2017 Recruiting --> Active, not recruiting | N=48 --> 28 | Trial primary completion date: Aug 2017 --> Sep 2016
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment closed, Enrollment change, Trial primary completion date:  EMR 63325-011: Common Safety Follow-up Trial of Tecemotide (L-BLP25) (clinicaltrials.gov) -  Nov 24, 2014   
    P=N/A,  N=20, Active, not recruiting, 
    Completed --> Active, not recruiting Enrolling by invitation --> Active, not recruiting | N=262 --> 20 | Trial primary completion date: Dec 2019 --> May 2015
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment closed:  Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START) (clinicaltrials.gov) -  Oct 28, 2014   
    P3,  N=1513, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=500 --> 40 | Trial primary completion date: May 2020 --> Mar 2015 Completed --> Active, not recruiting
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Trial primary completion date, Combination therapy:  EMR 63325-015: Tecemotide (L-BLP25) in Prostate Cancer (clinicaltrials.gov) -  Aug 1, 2014   
    P2,  N=48, Recruiting, 
    Active, not recruiting --> Completed Trial primary completion date: Jan 2016 --> Aug 2017
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment change, Trial initiation date, Combination therapy, Metastases:  STRIDE - STimulating Immune Response In aDvanced brEast Cancer (clinicaltrials.gov) -  Jul 24, 2014   
    P3,  N=16, Terminated, 
    Trial primary completion date: Jan 2016 --> Aug 2017 N=42 --> 16 | Initiation date: Jun 2009 --> Sep 2009
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment change, MSi-H Biomarker, IO biomarker:  SPRINT: Tecemotide (L-BLP25) in Rectal Cancer (clinicaltrials.gov) -  Jan 28, 2014   
    P2,  N=124, Active, not recruiting, 
    Not yet recruiting --> Recruiting N=87 --> 124
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment closed, MSi-H Biomarker, IO biomarker:  SPRINT: Tecemotide (L-BLP25) in Rectal Cancer (clinicaltrials.gov) -  Jan 28, 2014   
    P2,  N=124, Active, not recruiting, 
    N=87 --> 124 Recruiting --> Active, not recruiting
  • ||||||||||  Stimuvax (tecemotide) / EMD Serono, Ono Pharma
    Enrollment open:  EMR 63325-011: Common Safety Follow-up Trial of Tecemotide (L-BLP25) (clinicaltrials.gov) -  Feb 28, 2012   
    P=N/A,  N=250, Enrolling by invitation, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Enrolling by invitation