Imlygic (talimogene laherparepvec) / Amgen 
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  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Clinical, Journal:  Talimogene laherparepvec: review of its mechanism of action and clinical efficacy and safety. (Pubmed Central) -  Apr 12, 2020   
    Talimogene laherparepvec is a first-in-class, genetically modified, herpes simplex virus type 1-based oncolytic immunotherapy approved for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. This review highlights the dual mechanism of action for talimogene laherparepvec (direct tumor cell lysis and stimulation of local response in tumor microenvironment and systemic immune response in distant metastases), summarizes key preclinical and clinical trials evaluating efficacy and safety of talimogene laherparepvec in melanoma, and describes studies ongoing in other solid tumors.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus, IO Biomarker:  Potentiating Oncolytic Virus-Induced Immune-Mediated Tumor Cell Killing Using Histone Deacetylase Inhibition. (Pubmed Central) -  Apr 10, 2020   
    Mechanistically, VPA increased expression of activating ligands for NK cell recognition and induced expression of tumor-associated antigens, supporting innate NK cell killing and CTL priming. These data support the clinical combination of talimogene laherparepvec with histone deacetylase inhibition to enhance oncolysis and anti-tumor immunity.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
    Review, Journal, Oncolytic Virus:  Combination of Oncolytic Virotherapy and CAR T/NK Cell Therapy for the Treatment of Cancer (Pubmed Central) -  Apr 9, 2020   
    Namely, local acute inflammatory reaction induced by the viral infection may reverse tumor-associated immunosuppression and lead to more efficient homing and penetration of CAR-expressing lymphocytes into the tumor stroma; combined viral and CAR-mediated cytotoxicity may ensure the production of immunogenic cell debris and efficient presentation of tumor neoantigens, and potently recruit the patient's own bystander immune cells to attack cancer cells. Thus, testing the combinations of CAR-based and virolytic approaches in the clinical setting appears both logical and highly promising.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO Biomarker:  Targeted Therapy and Immunotherapy for Melanoma in Japan. (Pubmed Central) -  Mar 26, 2020   
    In the adjuvant setting, dabrafenib plus trametinb combination, nivolumab monotherapy, and pembrolizumab monotherapy were approved in July, August, and December 2018 in Japan, respectively...A phase III trial of adjuvant therapy with locoregional interferon (IFN)-β versus surgery alone is ongoing in Japan (JCOG1309, J-FERON), in which IFN-β is injected directly into the site of the primary tumor postoperatively, so that it would be drained through the untreated lymphatic route to the regional node basin...In conclusion, acral and mucosal melanomas have been treated based on the available medical evidence for the treatment of non-acral cutaneous melanomas. Considering the differences in genetic backgrounds and therapeutic efficacy of immunotherapy, specialized therapeutic strategies for these subtypes of melanoma should be established in the future.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Clinical, Journal, Real-World Evidence:  Real World Outcomes of Talimogene Laherparepvec Therapy: A Multi-Institutional Experience. (Pubmed Central) -  Mar 18, 2020   
    TVEC is a well-tolerated, durable treatment option for patients with unresectable locoregional melanoma particularly in stage IIIB/C disease. Additionally, we found that TVEC can be administered safely across anatomic sites that otherwise are not amenable to other local therapies.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    [VIRTUAL] Tumor Response Evaluation Criteria for Intratumoral Therapy (Room 31 A-C - Upper Lvl - SDCC) -  Mar 6, 2020 - Abstract #AACR2020AACR_1739;    
    In October 2015, the US FDA approved talimogene laherparepvec (T-vec), the first oncolytic virus therapy and the first intratumoral therapy, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery...Discuss the impact of imaging modalities on the response evaluation criteria; and 5. Discuss response criteria for intratumoral immunotherapy in solid tumors (itRECIST) and its potential advantages and challenges.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus:  Achieving systemic delivery of oncolytic viruses. (Pubmed Central) -  Mar 3, 2020   
    Studies proving the ability of oncolytic viruses (OVs) to target and rapidly kill cancer cells have led to approval of H101 and Imlygic®...For the technology to mature and become applicable across a wider range of patients/cancer indications, amenability to systemic delivery is required. This may be achieved using strategies that modulate the OV by genetic or chemical means and/or that alter the physiology of target tumors.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Checkpoint inhibitor treatment in patients with isolated in-transit melanoma metastases. (Poster Board 419) -  Feb 27, 2020 - Abstract #ASCO2020ASCO_884;    
    The results show a high response rate to CPI in patients with in-transit metastases and support early treatment with CPI following identification of in-transit metastases not curable with surgery whilst disease characteristics remain favourable. Research Funding: None
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus:  Determinants of combination GM-CSF immunotherapy and oncolytic virotherapy success identified through in silico treatment personalization. (Pubmed Central) -  Feb 15, 2020   
    More crucially, through evaluation of individualized regimens, we identified determinants of combination GM-CSF and T-VEC therapy that can be translated into clinically-actionable dosing strategies without further personalization. Our results serve as a proof-of-concept for interdisciplinary approaches to determining combination therapy, and suggest promising avenues of investigation towards tailored combination immunotherapy/oncolytic virotherapy.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus:  Viral oncolytic immunotherapy in the war on cancer: Infection control considerations. (Pubmed Central) -  Feb 14, 2020   
    In 2015, talimogene laherparepvec (TVEC) became the first agent in this class to gain FDA approval for treatment of melanoma, and several others are being developed...Additionally, we describe the current mechanism for evaluating the risk related to similar new agents entering clinical trials at our institution. Development of standarized approaches for the safe administration and precautions for ongoing care, especially in immunocompromised patients, are essential to support the broad adoption of this novel therapy.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases:  Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma (clinicaltrials.gov) -  Feb 5, 2020   
    P2,  N=0, Withdrawn, 
    Trial completion date: Jan 2020 --> Jun 2020 | Trial primary completion date: Jan 2020 --> Jun 2020 N=20 --> 0 | Trial completion date: Jun 2024 --> Feb 2020 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2021 --> Feb 2020
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Vectibix (panitumumab) / Amgen
    Trial initiation date, Tumor mutational burden:  Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin (clinicaltrials.gov) -  Jan 30, 2020   
    P1,  N=30, Not yet recruiting, 
    Biomarkers are needed to assist clinicians in evidence based clinical decision making after progression on first line immunotherapy to determine whether response can be achieved with second line immunotherapy. Initiation date: Dec 2019 --> Mar 2020
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
    Review, Journal:  Anti-PD-1 and Novel Combinations in the Treatment of Melanoma-An Update. (Pubmed Central) -  Jan 18, 2020   
    Nivolumab combined with ipilimumab achieves a 5 year survival rate of more than 50% but at a cost of high toxicity. Ongoing clinical trials investigate novel immunotherapy combinations and strategies (e.g., Talimogene laherparepvec (T-VEC), Bempegaldesleukin (BEMPEG), incorporation or sequencing of targeted therapy, incorporation or sequencing of radiotherapy), and focus on poor prognosis groups (e.g., high tumor burden/LDH levels, anti-PD-1 refractory melanoma, and brain metastases).
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Review, Journal, Oncolytic Virus:  Oncolytic Viruses for Cancer Therapy: Barriers and Recent Advances. (Pubmed Central) -  Dec 26, 2019   
    With the first OV (talimogene laherparepvec [T-vec]) obtaining US Food and Drug Administration approval, interest in OVs has been boosted greatly...Recent advances in viral retargeting, genetic editing, viral delivery platforms, tracking strategies, OV-based gene therapy, and combination strategies have the potential to broaden the applications of oncolytic virotherapy in oncology. In this review, we present several insights into the limitations and challenges of oncolytic virotherapy, describe the strategies mentioned above, provide a summary of recent preclinical and clinical trials in the field of oncolytic virotherapy, and highlight the need to optimize current strategies to improve clinical outcomes.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen, imatinib / Generic mfg., Tafinlar (dabrafenib) / Novartis
    Journal:  Changing Trends in Industry Funding for Surgical Oncologists. (Pubmed Central) -  Dec 23, 2019   
    The majority of industry research payments to SOs are related to novel pharmaceuticals, which highlights the expanding influence SOs play in systemic therapies. Industry payments are influenced by location, gender, and academic leadership.
  • ||||||||||  Zyclara (imiquimod) / Mochida, Mylan, Bausch Health, Imlygic (talimogene laherparepvec) / Amgen
    Review, Journal:  Topical and intralesional therapies for in-transitmelanoma. (Pubmed Central) -  Dec 8, 2019   
    In general, these agents are modestly effective and associated with frequent but only minor toxicity. As the mechanism of action of many of these agents includes initiation of a local immune response, combinations with immune checkpoint inhibitors are currently being explored.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal:  High Response Rates for T-VEC in Early Metastatic Melanoma (Stage IIIB/C-IVM1a). (Pubmed Central) -  Dec 6, 2019   
    Best ORR for T-VEC monotherapy at our institute was 88.5% with 61.5% achieving a CR. This prospective study for T-VEC in early metastatic (stage IIIB/C-IVM1a) melanoma demonstrated superior results to the phase 3 OPTiM study and confirms the role of oncolytic immunotherapy for melanoma.
  • ||||||||||  midazolam hydrochloride / generics
    Review, Journal:  Management of Locoregionally Advanced Melanoma. (Pubmed Central) -  Dec 5, 2019   
    Multimodal treatment strategy is imperative in the treatment of locoregionally advanced melanoma. One must be versed on these quickly evolving therapeutic options.
  • ||||||||||  Review, Journal:  Intratumoral Immunotherapy-Update 2019. (Pubmed Central) -  Dec 3, 2019   
    In 2019, a multitude of intratumoral immunotherapies with varied mechanisms of action, including nononcolytic viral therapies such as PV-10 and toll-like receptor 9 agonists and oncolytic viral therapies such as CAVATAK, Pexa-Vec, and HF10, have been extensively evaluated in clinical trials and demonstrated promising antitumor activity with tolerable toxicities in melanoma and other solid tumor types...This review summarizes current knowledge on intratumoral therapies, a novel modality with increased utility in cancer treatment, and T-VEC, the only U.S. FDA-approved oncolytic viral therapy, for medical oncologists. This review evaluates approaches to incorporate T-VEC into daily practice to offer the possibility of response in selected melanoma patients with manageable adverse events as compared with other available immunotherapies.