Imlygic (talimogene laherparepvec) News

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|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: What is new in the diagnosis and therapy of malignant melanoma? (Pubmed Central) - Apr 13, 2021
Significant progress has also been made in the treatment of patients with cerebral melanoma metastasis since studies indicate that both BRAF/MEK inhibitors and the immunotherapy with CTLA4 and PD-1 inhibitors are efficient in this group of patients. With this wide range of possible systemic therapies for advanced melanoma further studies regarding therapy sequence, combinations between targeted therapies and immunotherapy as well as biomarkers for treatment response are needed to help guide physicians find the optimal therapy for patients with advanced malignant melanoma.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] Recurrent melanoma treated with talimogene laherparepvec in combination with radiation therapy: a case report () - Apr 10, 2021 - Abstract #AADVMX2021AAD_VMX_875;
There is limited literature concerning the management of advanced melanoma with T-VEC in combination with radiation, and this case demonstrates its utility clinically and supports the synergistic effects seen in mouse models [2]. This patient’s impressive improvement highlights the utility of TVEC and radiation as a valuable treatment option that Dermatologists and Oncologists should consider in the setting of advanced localized disease as an alternative or adjuvant to surgical intervention, and especially in unresectable localized recurrent melanomas.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, IO biomarker: Novel transcription regulatory sequences and factors of the immune evasion protein ICP47 (US12) of herpes simplex viruses. (Pubmed Central) - Apr 10, 2021
This patient’s impressive improvement highlights the utility of TVEC and radiation as a valuable treatment option that Dermatologists and Oncologists should consider in the setting of advanced localized disease as an alternative or adjuvant to surgical intervention, and especially in unresectable localized recurrent melanomas. Our findings have important implication to HSV biology, infection, immunity and oHSVs.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Talimogene Laherparepvec (T-VEC): An Intralesional Cancer Immunotherapy for Advanced Melanoma. (Pubmed Central) - Apr 7, 2021
In fact, despite improved local disease control and a trend toward superior overall survival in respect to the comparator GM-CSF (which was injected subcutaneously daily for two weeks), responses as a single agent therapy have been uncommon in patients with visceral metastases. For this reason, T-VEC is currently being evaluated in combinations with other immune checkpoint inhibitors such as ipilimumab and pembrolizumab, with interesting confirmation of activity even systemically.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Systemic Therapy of Metastatic Melanoma: On the Road to Cure. (Pubmed Central) - Apr 7, 2021
Today, novel combinations of such immune checkpoint inhibitors (ICIs) are under investigation, for example with cytokines and oncolytic viruses (i.e., pegylated interleukin-2, talimogene laherparepvec)...Several studies focus particularly on poor prognosis patients, as e.g., on anti-PD-1 refractory melanoma, patients with brain metastases, or uveal melanoma. It is hoped, on the road to cure, that these new approaches further improve long term survival in patients with advanced or metastatic melanoma.

|||||||||| Journal: The Rapid Development and Early Success of Covid 19 Vaccines Have Raised Hopes for Accelerating the Cancer Treatment Mechanism. (Pubmed Central) - Apr 7, 2021
An example of an anti-idiotype antibody is Racotumomab or Vaxira (Cancer, 2016)...There are currently FDA-approved products for helping cancer treatment such as BREYANZI, TECARTUS and YESCARTA for lymphoma, IMLYGIC for melanoma, KYMRIAH for acute lymphoblastic leukemia, and PROVENGE for prostate cancer...The current pandemic situation has necessitated the acceleration of Covid 19 vaccines and drugs and national and international protocols for their approval. If the currently produced vaccines can continue to be as successful as the preclinical and early phase studies, these changes and evolution have raised hopes for accelerating the use of these technologies and mechanisms in the field of cancer and other diseases vaccines, including HIV and influenza.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] Safety of Talimogene Laherparepvec in the Geriatric Melanoma Patient: A Multi-Institutional Experience () - Mar 26, 2021 - Abstract #SSO2021SSO_440;
The adverse events seen in this geriatric cohort are consistent with those reported in the literature, with few patients hospitalized or discontinuing therapy due to AE. This study provides evidence for surgeons to guide in shared-decision making when implementing TVEC therapy for metastatic melanoma in the geriatric patient.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Clinical: As a patient who luckily (four years ago) was presented with the actual trial drug (Keytruda and T-Vec), it literally saved my life. I can’t thank #ClevelandClinic, #TaussigCancerCenter, @FunchainMD, @DrKyleNealeHPM enough for the kindness extended to my family. (Twitter) - Mar 25, 2021

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases:  Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). (clinicaltrials.gov) -  Mar 23, 2021
P2, N=72, Active, not recruiting,  Sponsor: Amgen
This study provides evidence for surgeons to guide in shared-decision making when implementing TVEC therapy for metastatic melanoma in the geriatric patient. Trial completion date: Jul 2024 --> Feb 2024 | Trial primary completion date: Jan 2022 --> Aug 2021

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases:  T-VEC in Non-melanoma Skin Cancer (clinicaltrials.gov) -  Mar 19, 2021
P1, N=20, Recruiting,  Sponsor: University of Zurich
Trial completion date: Jul 2024 --> Feb 2024 | Trial primary completion date: Jan 2022 --> Aug 2021 Trial completion date: Dec 2020 --> Feb 2022 | Trial primary completion date: Feb 2020 --> Feb 2022

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change, Tumor mutational burden:  Glaspy BMS CA209-9ET Breast: Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted (clinicaltrials.gov) -  Mar 19, 2021
P1, N=6, Active, not recruiting,  Sponsor: Jonsson Comprehensive Cancer Center
Trial completion date: Dec 2020 --> Feb 2022 | Trial primary completion date: Feb 2020 --> Feb 2022 Recruiting --> Active, not recruiting | N=20 --> 6

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases:  Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors (clinicaltrials.gov) -  Mar 18, 2021
P1, N=18, Recruiting,  Sponsor: Amgen
Recruiting --> Active, not recruiting | N=20 --> 6 Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Feb 2022 --> Aug 2022

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Preclinical, Journal, IO biomarker: The Novel Oncolytic Herpes Simplex Virus Type-1 (HSV-1) VC2 Promotes Long-lasting, Systemic Anti-melanoma Tumor Immune Responses and Increased Survival in an Immunocompetent B16F10-derived Mouse Melanoma Model. (Pubmed Central) - Mar 16, 2021
The only currently FDA-approved oncolytic virotherapy, T-Vec, is a modified type 1 herpes simplex virus (HSV-1)...Additionally, due to the high rates of survival and the dependence on CD8+ T-cells for efficacy, our model will enable study of the immunological correlates of protection for VC2 oncolytic virotherapy and oncolytic virotherapy in general. Understanding the mechanisms of efficacious oncolytic virotherapy will inform the rational design of improved oncolytic virotherapies.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases:  A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma (clinicaltrials.gov) -  Mar 15, 2021
P2, N=60, Recruiting,  Sponsor: Memorial Sloan Kettering Cancer Center
Understanding the mechanisms of efficacious oncolytic virotherapy will inform the rational design of improved oncolytic virotherapies. Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, Oncolytic Virus, Checkpoint inhibition: Oncolytic Viruses and Immune Checkpoint Inhibitors: Preclinical Developments to Clinical Trials. (Pubmed Central) - Mar 5, 2021
For this reason, OVs serve as ideal complements to ICIs, and multiple preclinical studies and clinical trials are demonstrating their combined therapeutic efficacy. This review will discuss the merits and limitations of OVs and ICIs as monotherapy then progress onto the preclinical rationale and the results of clinical trials of key combination therapies.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Overcoming Immune Evasion in Melanoma. (Pubmed Central) - Mar 5, 2021
The proposed mechanism of action and the roles of immunotherapeutic agents, ipilimumab, nivolumab, pembrolizumab, and atezolizumab, adoptive T- cell therapy plus T-VEC in the treatment of advanced melanoma are discussed. In this review, we implore that a better understanding of the steps that mediate melanoma onset and progression, immune evasion strategies exploited by these tumor cells, and the identification of biomarkers to predict treatment response are critical in the design of improved strategies to improve clinical outcomes for patients with this deadly disease.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: The Current State of Oncolytic Herpes Simplex Virus for Glioblastoma Treatment. (Pubmed Central) - Mar 5, 2021
The recent emergence of immuno-virotherapy and FDA approval of T-VEC have generated a great expectation towards oncolytic herpes simplex viruses (oHSVs) as a promising treatment option for GBM...Here, we revisit the literature to understand the recent advancement of oHSV in the treatment of GBM. In addition, we discuss current obstacles to oHSV-based therapies and possible strategies to overcome these pitfalls.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change:  A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors (clinicaltrials.gov) -  Mar 3, 2021
P2, N=19, Active, not recruiting,  Sponsor: Memorial Sloan Kettering Cancer Center
In addition, we discuss current obstacles to oHSV-based therapies and possible strategies to overcome these pitfalls. Recruiting --> Active, not recruiting | N=34 --> 19

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] Moving beyond T-VEC – novel virotherapies (HALL B) - Mar 1, 2021 - Abstract #EADOWCM2021EADO-WCM_58;

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic Virus: The Present Status of Immuno-Oncolytic Viruses in the Treatment of Pancreatic Cancer. (Pubmed Central) - Feb 27, 2021
While many vectors have been explored, few show promise as treatment for pancreatic cancer, and fewer still have progressed to clinical trial evaluation. This review outlines recent strategies in the development of OVs targeting treatment of PDAC, current state of preclinical and clinical investigation and application.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). (clinicaltrials.gov) -  Feb 18, 2021
P2, N=100, Active, not recruiting,  Sponsor: Amgen
This review outlines recent strategies in the development of OVs targeting treatment of PDAC, current state of preclinical and clinical investigation and application. Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Sep 2021 --> Jan 2022

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Viral Nanoparticles: Cancer Vaccines and Immune Modulators. (Pubmed Central) - Feb 17, 2021
This category of viruses, named 'Oncolytic viruses', have been investigated and used for cancer treatment in the past decades resulting in the approval of the first oncolytic virus, a herpes simplex virus expressing a stimulating factor, named T-Vec, in 2015...Viruses experienced then a renaissance not only as infecting agent but as nanoparticle and cancer vaccines too. These strategies bring new life to the concept of using viruses as viral particles for therapeutic applications.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] Circulating tumor DNA as a biomarker for treatment response in an advanced Merkel cell carcinoma patient () - Feb 12, 2021 - Abstract #SID2021SID_444;
Our patient is a 70-year-old female whose MCC initially recurred after surgery and progressed on pembrolizumab, with debilitating side effects...As her MCC was extremely aggressive and had recurred shortly after every prior treatment modality, this is a promising outcome. Our pioneer observation underpins future study to ascertain the transformative role of ctDNA in MCC management, including post-operative risk stratification, early detection of relapse, biomarkers for treatment response and prognosis.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic Virus: From threat to cure: understanding of virus-induced cell death leads to highly immunogenic oncolytic influenza viruses. (Pubmed Central) - Feb 11, 2021
The first oncolytic virus, Talimogene laherparepvec (T-VEC), based on herpes simplex virus 1 (HSV-1), was approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2015...We discuss strategies for targeting viral replication to cancerous lesions and arming them with immunogenic transgenes. We furthermore describe which modes of cell death are induced by influenza A virus infection and how these insights may be utilized to optimize influenza A virus-based oncolytic virus design.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date:  TEMPO: Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (clinicaltrials.gov) -  Feb 10, 2021
P1, N=24, Recruiting,  Sponsor: Dan Blazer III, M.D.
We furthermore describe which modes of cell death are induced by influenza A virus infection and how these insights may be utilized to optimize influenza A virus-based oncolytic virus design. Trial completion date: Mar 2022 --> Sep 2022 | Trial primary completion date: Mar 2021 --> Sep 2021

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Biomarker, Retrospective data, Journal: Lower Genital Tract Melanomas: Staging, Predictors of Outcome, and New Therapeutic Options. (Pubmed Central) - Feb 9, 2021
Surgery has a therapeutic effect in early stage LGTM. Advanced stages may be treated with immunotherapy, radiation therapy, a combination of both, and oncolytic viral immunotherapy.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic Virus: Oncolytic Virotherapy Shows Promise for Cutaneous B-cell Lymphoma. (Pubmed Central) - Jan 31, 2021
Advanced stages may be treated with immunotherapy, radiation therapy, a combination of both, and oncolytic viral immunotherapy. T-VEC virotherapy yielded complete responses in injected lesions in 46% of patients in a phase I trial.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion:  Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma (clinicaltrials.gov) -  Jan 26, 2021
P2, N=112, Completed,  Sponsor: Amgen
T-VEC virotherapy yielded complete responses in injected lesions in 46% of patients in a phase I trial. Active, not recruiting --> Completed

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: How We Do It: Administration Guide for Intralesional Immunotherapy With Talimogene Laherparepvec (T-VEC) for Advanced Melanoma. (Pubmed Central) - Jan 23, 2021
Active, not recruiting --> Completed No abstract available

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic Virus: Review of Talimogene Laherparepvec (T-VEC): A First in Class Oncolytic Viral Treatment of Advanced Melanoma. (Pubmed Central) - Jan 23, 2021
Phase I to III clinical trials and early real-world experience have demonstrated the efficacy of T-VEC in advanced melanoma as single or combination therapy with tolerable adverse effects. We conclude that with a standardized clinical approach and training, dermatologists can pave the way in using T-VEC and future oncolytic virus therapies in appropriate clinical scenarios.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Journal, Combination therapy, Oncolytic Virus, Checkpoint inhibition: Combination therapy with oncolytic viruses and immune checkpoint inhibitors. (Pubmed Central) - Jan 13, 2021
We also explore the future directions of this novel combination strategy.Expert opinion: The imminent results of the Phase 3 study combining pembrolizumab with or without T-Vec injection are eagerly awaited. OV/ICI combinations remain one of the most promising avenues to explore in the success of cancer immunotherapy.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, PD(L)-1 Biomarker, IO biomarker: An update on the safety of nivolumab for the treatment of advanced melanoma. (Pubmed Central) - Jan 8, 2021
Introduction: Due to its unique mechanism of action as an immune checkpoint inhibitor, nivolumab has high antitumor activity, but at the same time this mechanism is responsible for immune-related adverse events that may limit patients' safety and therapy continuation.Areas covered: Long term safety of nivolumab including 5-year follow-up, safety of nivolumab treatment after ipilimumab therapy, safety of nivolumab in challenging subgroups (elderly, patients with brain metastases, patients with autoimmune disorders), safety of nivolumab in with rare melanoma subtypes (including mucosal melanoma), as well as specificity of AEs reported for nivolumab treatment in melanoma patients in comparison to other cancer types and other immunotherapy molecules, and impact of AEs on response rates and PFS on nivolumab treatment are discussed.Expert opinion: Search for biomarkers that would help us to identify patient populations that may suffer from severe nivolumab toxicity could help in selecting patients that should not be treated with this type of therapy. Novel combinations and immunotherapy drugs including use of NKTR-214 (IL-2 pathway), lymphocyte-activation gene 3 (LAG-3), local injections of talimogene laherparepvec (T-VEC) or systemic use of T-cell receptors agonists such as OX40, CD137, ICOS-1, could provide regimens with limited toxicity and higher activity.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Tecentriq (atezolizumab) / Roche
Trial primary completion date, PD(L)-1 Biomarker:  PROMETEO: Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer (clinicaltrials.gov) -  Jan 6, 2021
P1, N=30, Recruiting,  Sponsor: SOLTI Breast Cancer Research Group
Novel combinations and immunotherapy drugs including use of NKTR-214 (IL-2 pathway), lymphocyte-activation gene 3 (LAG-3), local injections of talimogene laherparepvec (T-VEC) or systemic use of T-cell receptors agonists such as OX40, CD137, ICOS-1, could provide regimens with limited toxicity and higher activity. Trial primary completion date: Nov 2020 --> Dec 2021

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date:  Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma (clinicaltrials.gov) -  Jan 5, 2021
P2, N=112, Active, not recruiting,  Sponsor: Amgen
Trial primary completion date: Nov 2020 --> Dec 2021 Trial completion date: Mar 2021 --> Dec 2020

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal: Erfolgreiche Behandlung eines metastasierenden Melanoms mit Talimogen laherparepvec (T-VEC) bei einer lebertransplantierten Patientin. (Pubmed Central) - Dec 31, 2020
Trial completion date: Mar 2021 --> Dec 2020 No abstract available

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal: Assessment of Image-Guided Intratumoral Delivery of Immunotherapeutics in Patients With Cancer. (Pubmed Central) - Dec 30, 2020
Image-guided biopsies and intratumoral injections of immunotherapies across several clinical trials as well as standard of care talimogene laherparepvec therapy...Performing physicians should have the necessary safeguards in place to respond as needed. Optimal methods for intratumoral drug delivery remain unresolved, and efforts to standardize drug delivery techniques are required.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Preclinical, Journal: Oncolytic effects of the recombinant Newcastle disease virus, rAF-IL12, against colon cancer cells in vitro and in tumor-challenged NCr-Foxn1nu nude mice. (Pubmed Central) - Dec 30, 2020
Alternative modalities such as the use of viral-based therapeutic cancer vaccine is still limited, with only the herpes simplex virus (HSV) expressing granulocyte-macrophage colony- stimulating factor (GM-CSF) or talimogene laherparepvec (T-Vec) being approved in the USA and Europe so far...Besides, rAF-IL12 intra-tumoral delivery was considered safe and was not hazardous to the host as evidenced in pathophysiology of the normal tissues and organs of the mice as well as from the serum biochemistry profile of liver and kidney. Therefore, this study proves that rAF-IL12 had better cytotoxicity effects than its parental AF2240-i and could potentially be an ideal treatment for colon cancer in the near future.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Tumor mutational burden:  myDCTV: Intratumoral Injection of Autologous CD1c (BDCA-1)+ Myeloid Dendritic Cells Plus Talimogene Laherparepvec (T-VEC) (clinicaltrials.gov) -  Dec 29, 2020
P1, N=18, Active, not recruiting,  Sponsor: Universitair Ziekenhuis Brussel
Therefore, this study proves that rAF-IL12 had better cytotoxicity effects than its parental AF2240-i and could potentially be an ideal treatment for colon cancer in the near future. Recruiting --> Active, not recruiting

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical: We are looking for a multi-center study in the use of T-VEC in transplant receipients. Plz msg me If you have patients and want to collaborate. See our prior Letter to the Editor with @MallikaGuptaMD https://t.co/GvWHuMc5to (Twitter) - Dec 23, 2020

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Clinical, P2 data, Journal, Combination therapy, PD(L)-1 Biomarker: Objective Response Rate Among Patients With Locally Advanced or Metastatic Sarcoma Treated With Talimogene Laherparepvec in Combination With Pembrolizumab: A Phase 2 Clinical Trial. (Pubmed Central) - Dec 20, 2020
P2
This combination therapy met its predefined primary study end point; further evaluation of T-VEC in combination with pembrolizumab for patients with select sarcoma subtypes is planned. ClinicalTrials.gov identifier: NCT03069378.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Cavatak (CVA21) / Merck (MSD)
Clinical, Journal, Oncolytic Virus, IO Biomarker: Oncolytic Immunotherapy for Bladder Cancer Using Coxsackie A21 Virus: Using a Bladder Tumor Precision-Cut Slice Model System to Assess Viral Efficacy. (Pubmed Central) - Dec 18, 2020
Coxsackievirus A21 (CVA21) is a novel intercellular adhesion molecule-1 (ICAM-1)-targeted immunotherapeutic virus...In this chapter we demonstrate the utility of the precision cut tumor slice model as a unique organotypic model to test oncolytic viruses. We will describe how to prepare and slice the tumor using a vibrating microtome together with the optimum culture and conditions for treatment.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, IO biomarker, Surgery:  Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (clinicaltrials.gov) -  Dec 17, 2020
P2, N=40, Recruiting,  Sponsor: National Cancer Institute (NCI)
We will describe how to prepare and slice the tumor using a vibrating microtome together with the optimum culture and conditions for treatment. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Enrollment change:  T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer (clinicaltrials.gov) -  Dec 17, 2020
P1b, N=25, Recruiting,  Sponsor: University of California, San Francisco
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 N=15 --> 25

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Tumor mutational burden:  myDCTV: Intratumoral Injection of Autologous CD1c (BDCA-1)+ Myeloid Dendritic Cells Plus Talimogene Laherparepvec (T-VEC) (clinicaltrials.gov) -  Dec 17, 2020
P1, N=18, Recruiting,  Sponsor: Universitair Ziekenhuis Brussel
N=15 --> 25 Trial completion date: Oct 2019 --> Oct 2023 | Trial primary completion date: Oct 2019 --> Oct 2023

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Come over to #oncology - we’ve got some good ones 😳 Here’s an example: Talimogene laherparepvec (brand name = Imlygic), referred to as “t-vec” #oncopharm (Twitter) - Dec 14, 2020

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Glybera (alipogene tiparvovec) / uniQure, Chiesi, Xenon
Journal: Engineering HSV-1 Vectors for Gene Therapy. (Pubmed Central) - Dec 3, 2020
Virus vectors have been employed as gene transfer vehicles for various preclinical and clinical gene therapy applications and with the approval of Glybera (Alipogene tiparvovec) as the first gene therapy product as a standard medical treatment (Yla-Herttuala, Mol Ther 20:1831-1832, 2013), gene therapy has reached the status of being a part of standard patient care...In fact, Imlygic (T-VEC, Talimogene laherparepvec, formerly known as OncoVex GM-CSF), displayed efficacy in a recent Phase-III trial when compared to standard GM-CSF treatment alone (Andtbacka et al., J Clin Oncol 31:sLBA9008, 2013), and has since become the first FDA-approved viral gene therapy product used in standard patient care (October 2015) (Pol et al., Oncoimmunology 5:e1115641, 2016)...Research during the last decade on the development of HSV vectors has resulted in the engineering of recombinant vectors that are completely replication defective, nontoxic, and capable of long-term transgene expression in neurons. This chapter describes methods for the construction of recombinant genomic HSV vectors based on the HSV-1 replication-defective vector backbones, steps in their purification, and their small-scale production for use in cell culture experiments as well as preclinical animal studies.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Review, Journal, Oncolytic Virus: HSV-1 Oncolytic Viruses from Bench to Bedside: An Overview of Current Clinical Trials. (Pubmed Central) - Dec 2, 2020
Successful clinical data resulted in the FDA-approval of the oHSV talimogene laherparepvec (T-Vec) in 2015, and several other variants are currently undergoing clinical assessment and may expand the landscape of future oncologic therapy options. This review offers a detailed overview of the latest results from clinical trials as well as an outlook on newly developed HSV-1 oncolytic variants with improved tumor selectivity, replication, and immunostimulatory capacity and related clinical studies.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases:  Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). (clinicaltrials.gov) -  Nov 30, 2020
P2, N=100, Recruiting,  Sponsor: Amgen
This review offers a detailed overview of the latest results from clinical trials as well as an outlook on newly developed HSV-1 oncolytic variants with improved tumor selectivity, replication, and immunostimulatory capacity and related clinical studies. Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: May 2021 --> Sep 2021

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date:  Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma (clinicaltrials.gov) -  Nov 27, 2020
P1, N=18, Active, not recruiting,  Sponsor: Amgen
Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: May 2021 --> Sep 2021 Trial completion date: Apr 2021 --> Jan 2023

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic Virus: Mapping the preclinical to clinical evidence and development trajectory of the oncolytic virus talimogene laherparepvec (T-VEC): a systematic review. (Pubmed Central) - Nov 22, 2020
Our findings illustrate that even successful biotherapeutics may not demonstrate a clear translational road map. This emphasises the need to consider increasing rigour and transparency along the translational pathway.



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