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Talimogene laherparepvec

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https://www.readbyqxmd.com/read/27922859/fdg-pet-ct-for-monitoring-response-of-melanoma-to-the-novel-oncolytic-viral-therapy-talimogene-laherparepvec
#1
Matthew F Covington, Clara N Curiel, Lois Lattimore, Ryan J Avery, Phillip H Kuo
61-year-old woman with stage IIIa (T3a N1a M0) left lower leg melanoma with lesions suggestive of in-transit metastases 8 months following wide local excision and femoral nodal dissection. FDG-PET/CT demonstrated 5 FDG-avid in-transit nodal metastases in the distal left leg, confirmed on biopsy. Talimogene laherparepvec (T-VEC) oncolytic immunotherapy consisting of intralesional injections of modified herpes simplex virus-expressing granulocyte-macrophage colony-stimulating factor was completed over 6 months...
December 3, 2016: Clinical Nuclear Medicine
https://www.readbyqxmd.com/read/27895500/efficacy-and-safety-of-talimogene-laherparepvec-versus-granulocyte-macrophage-colony-stimulating-factor-in-patients-with-stage-iiib-c-and-ivm1a-melanoma-subanalysis-of-the-phase-iii-optim-trial
#2
Kevin J Harrington, Robert Hi Andtbacka, Frances Collichio, Gerald Downey, Lisa Chen, Zsolt Szabo, Howard L Kaufman
OBJECTIVES: Talimogene laherparepvec is the first oncolytic immunotherapy to receive approval in Europe, the USA and Australia. In the randomized, open-label Phase III OPTiM trial (NCT00769704), talimogene laherparepvec significantly improved durable response rate (DRR) versus granulocyte-macrophage colony-stimulating factor (GM-CSF) in 436 patients with unresectable stage IIIB-IVM1c melanoma. The median overall survival (OS) was longer versus GM-CSF in patients with earlier-stage melanoma (IIIB-IVM1a)...
2016: OncoTargets and Therapy
https://www.readbyqxmd.com/read/27785448/spotlight-on-talimogene-laherparepvec-for-the-treatment-of-melanoma-lesions-in-the-skin-and-lymph-nodes
#3
REVIEW
Marlana Orloff
On October 27, 2015, talimogene laherparepvec (T-VEC), a first in class intralesional oncolytic virotherapy, was granted the US Food and Drug Administration approval for the treatment of melanoma in the skin and lymph nodes. Its approval has added yet another therapeutic option to the growing list of effective therapies for melanoma. Though the Phase III OPTiM trial has demonstrated its efficacy as a single agent, the target patient population remains narrow. With numerous effective and tolerable treatments available for unresectable and metastatic melanoma, intralesional therapies such as T-VEC are still finding their niche...
2016: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/27769635/immunotherapy-in-melanoma-recent-advances-and-future-directions
#4
C Franklin, E Livingstone, A Roesch, B Schilling, D Schadendorf
Malignant melanoma contributes the majority of skin cancer related deaths and shows an increasing incidence in the past years. Despite all efforts of early diagnosis, metastatic melanoma still has a poor prognosis and remains a challenge for treating physicians. In recent years, improved knowledge of the pathophysiology and a better understanding of the role of the immune system in tumour control have led to the development and approval of several immunotherapies. Monoclonal antibodies against different immune checkpoints have been revolutionizing the treatment of metastatic and unresectable melanoma...
September 2, 2016: European Journal of Surgical Oncology
https://www.readbyqxmd.com/read/27692478/nice-guidance-for-talimogene-laherparepvec-for-unresectable-metastatic-melanoma
#5
Jane Adam, Janet Robertson, Eleanor Donegan, Irina Voicechovskaja
No abstract text is available yet for this article.
September 27, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27688833/economic-burden-of-toxicities-associated-with-treating-metastatic-melanoma-in-the-united-states
#6
S Pinar Bilir, Qiufei Ma, Zhongyun Zhao, Elizabeth Wehler, Julie Munakata, Beth Barber
BACKGROUND: Little has been reported on the costs of managing the adverse events (AEs) associated with current therapies for patients with regional or distant metastatic melanoma. OBJECTIVES: To identify treatment-related AEs in patients with metastatic melanoma and to estimate the associated costs of treating these AEs in the United States. METHODS: A cost-estimation study for AEs associated with treatment of metastatic melanoma was conducted from 2012 to 2013 by identifying grades 3 and 4 AEs through the use of a comprehensive search of drug labels and English-language, published phase 2/3 studies in PubMed, conference abstracts, and the National Comprehensive Cancer Network guidelines...
June 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/27680683/recurrent-loss-of-sting-signaling-in-melanoma-correlates-with-susceptibility-to-viral-oncolysis
#7
Tianli Xia, Hiroyasu Konno, Glen N Barber
The innate immune regulator STING stimulates cytokine production in response to the presence of cytosolic DNA, which can arise following DNA damage. Extrinsic STING signaling is also needed for antigen-presenting cells (APC) to stimulate antitumor T cell immunity. Here we show that STING signaling is recurrently suppressed in melanoma cells, where this event may enable immune escape after DNA damage. Mechanistically STING signaling was suppressed most frequently by epigenetic silencing of either STING or the cyclic GMP-AMP synthase (cGAS), which generates STING-activating cyclic dinucleotides (CDNs) after binding cytosolic DNA species...
September 28, 2016: Cancer Research
https://www.readbyqxmd.com/read/27660707/into-the-clinic-talimogene-laherparepvec-t-vec-a-first-in-class-intratumoral-oncolytic-viral-therapy
#8
Hasan Rehman, Ann W Silk, Michael P Kane, Howard L Kaufman
With the recent regulatory approval of Talimogene laherparepvec (T-VEC) for the treatment of advanced of melanoma in the United States, Europe and Australia, oncolytic virus immunotherapy has earned its place in the clinic. However, the adoption of T-VEC by the U.S. oncology community has been slow, and so far has been largely limited to specialized cancer centers. Limiting factors include the intratumoral route of administration, which is unfamiliar to medical oncologists, biosafety concerns related to the use of a live virus in the clinic, and the explosion of other therapeutic strategies now available for the treatment of advanced melanoma...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27645330/cutaneous-complications-of-targeted-melanoma-therapy
#9
REVIEW
Emily de Golian, Bernice Y Kwong, Susan M Swetter, Silvina B Pugliese
The landscape of advanced and metastatic melanoma therapy has shifted dramatically in recent years. Since 2011, eight drugs (ipilimumab, vemurafenib, dabrafenib, trametinib, cometinib, pembrolizumab, nivolumab, and talimogene laherparepvec) have received FDA approval for the treatment of advanced or metastatic melanoma, including combination regimens of both small molecule kinase and immune checkpoint inhibitors. These therapies have revolutionized the management of unresectable regional nodal and distant melanoma, providing hope of extended survival to patients...
November 2016: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/27635234/virotherapy-cancer-gene-therapy-at-last
#10
REVIEW
Alan E Bilsland, Pavlina Spiliopoulou, T R Jeffry Evans
For decades, effective cancer gene therapy has been a tantalising prospect; for a therapeutic modality potentially able to elicit highly effective and selective responses, definitive efficacy outcomes have often seemed out of reach. However, steady progress in vector development and accumulated experience from previous clinical studies has finally led the field to its first licensed therapy. Following a pivotal phase III trial, Imlygic (talimogene laherparepvec/T-Vec) received US approval as a treatment for cutaneous and subcutaneous melanoma in October 2015, followed several weeks later by its European authorisation...
2016: F1000Research
https://www.readbyqxmd.com/read/27602429/intralesional-and-systemic-immunotherapy-for-metastatic-melanoma
#11
Carrie Luu, Nikhil I Khushalani, Jonathan S Zager
INTRODUCTION: Immunotherapy has revolutionized the treatment of metastatic melanoma and dramatically improved patient outcomes. Ipilimumab, an inhibitor of cytotoxic T-lymphocyte antigen-4 (CTLA-4), was the first immunotherapeutic agent to demonstrate improved survival in advanced melanoma. More recently, other immune checkpoint inhibitors, including the programmed death-1 (PD-1) inhibitors pembrolizumab and nivolumab, have demonstrated efficacy in locally advanced unresectable and metastatic melanoma...
September 20, 2016: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27516203/talimogene-laherparepvec-a-review-in-unresectable-metastatic-melanoma
#12
Karly P Garnock-Jones
Talimogene laherparepvec (Imlygic™) is a first-in-class oncolytic viral immunotherapy derived from herpes simplex virus type 1, which has been genetically modified to increase tumour selectivity and stimulate antitumour immune response. This article reviews the pharmacological properties of intralesional talimogene laherparepvec and its clinical efficacy and tolerability in patients with unresectable metastatic melanoma. In the phase III OPTiM trial, talimogene laherparepvec was more effective than subcutaneous human granulocyte-macrophage colony-stimulating factor (GM-CSF), both in patients with stage IIIB-IV melanoma [intention-to-treat (ITT) population] and in those with stage IIIB-IVM1a disease (in an exploratory subgroup analysis)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27512683/oncolytic-virotherapy-using-herpes-simplex-virus-how-far-have-we-come
#13
REVIEW
Nicolas As Sokolowski, Helen Rizos, Russell J Diefenbach
Oncolytic virotherapy exploits the properties of human viruses to naturally cytolysis of cancer cells. The human pathogen herpes simplex virus (HSV) has proven particularly amenable for use in oncolytic virotherapy. The relative safety of HSV coupled with extensive knowledge on how HSV interacts with the host has provided a platform for manipulating HSV to enhance the targeting and killing of human cancer cells. This has culminated in the approval of talimogene laherparepvec for the treatment of melanoma. This review focuses on the development of HSV as an oncolytic virus and where the field is likely to head in the future...
2015: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/27512660/critical-analysis-of-an-oncolytic-herpesvirus-encoding-granulocyte-macrophage-colony-stimulating-factor-for-the-treatment-of-malignant-melanoma
#14
REVIEW
Tasha Hughes, Robert S Coffin, Caroline E Lilley, Rafael Ponce, Howard L Kaufman
Oncolytic viruses that selectively lyse tumor cells with minimal damage to normal cells are a new area of therapeutic development in oncology. An attenuated herpesvirus encoding the granulocyte-macrophage colony stimulating factor (GM-CSF), known as talimogene laherparepvec (T-VEC), has been identified as an attractive oncolytic virus for cancer therapy based on preclinical tumor studies and results from early-phase clinical trials and a large randomized Phase III study in melanoma. In this review, we discuss the basic biology of T-VEC, describe the role of GM-CSF as an immune adjuvant, summarize the preclinical data, and report the outcomes of published clinical trials using T-VEC...
2014: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/27512658/oncolytic-herpes-viruses-chemotherapeutics-and-other-cancer-drugs
#15
REVIEW
Lynne Braidwood, Sheila V Graham, Alex Graham, Joe Conner
Oncolytic viruses are emerging as a potential new way of treating cancers. They are selectively replication-competent viruses that propagate only in actively dividing tumor cells but not in normal cells and, as a result, destroy the tumor cells by consequence of lytic infection. At least six different oncolytic herpes simplex viruses (oHSVs) have undergone clinical trials worldwide to date, and they have demonstrated an excellent safety profile and intimations of efficacy. The first pivotal Phase III trial with an oHSV, talimogene laherparepvec (T-Vec [OncoVex(GM-CSF)]), is almost complete, with extremely positive early results reported...
2013: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/27487099/the-role-of-talimogene-laherparepvec-t-vec-in-the-age-of-checkpoint-inhibitors
#16
Robert H Andtbacka
No abstract text is available yet for this article.
August 2016: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/27486853/oncolytic-virus-therapy-a-new-era-of-cancer-treatment-at-dawn
#17
REVIEW
Hiroshi Fukuhara, Yasushi Ino, Tomoki Todo
Oncolytic virus therapy is perhaps the next major breakthrough in cancer treatment following the success in immunotherapy using immune checkpoint inhibitors. Oncolytic viruses are defined as genetically engineered or naturally occurring viruses that selectively replicate in and kill cancer cells without harming the normal tissues. T-Vec (talimogene laherparepvec), a second-generation oncolytic herpes simplex virus type 1 (HSV-1) armed with GM-CSF, was recently approved as the first oncolytic virus drug in the USA and Europe...
October 2016: Cancer Science
https://www.readbyqxmd.com/read/27441411/oncolytic-viruses-in-cancer-treatment-a-review
#18
Sean E Lawler, Maria-Carmela Speranza, Choi-Fong Cho, E Antonio Chiocca
Importance: Oncolytic viruses (OVs) are emerging as important agents in cancer treatment. Oncolytic viruses offer the attractive therapeutic combination of tumor-specific cell lysis together with immune stimulation, therefore acting as potential in situ tumor vaccines. Moreover, OVs can be engineered for optimization of tumor selectivity and enhanced immune stimulation and can be readily combined with other agents. The effectiveness of OVs has been demonstrated in many preclinical studies and recently in humans, with US Food and Drug Administration approval of the oncolytic herpesvirus talimogene laherparepvec in advanced melanoma, a major breakthrough for the field...
July 21, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27407058/cutaneous-head-and-neck-melanoma-in-optim-a-randomized-phase-3-trial-of-talimogene-laherparepvec-versus-granulocyte-macrophage-colony-stimulating-factor-for-the-treatment-of-unresected-stage-iiib-iiic-iv-melanoma
#19
Robert H I Andtbacka, Sanjiv S Agarwala, David W Ollila, Sigrun Hallmeyer, Mohammed Milhem, Thomas Amatruda, John J Nemunaitis, Kevin J Harrington, Lisa Chen, Mark Shilkrut, Merrick Ross, Howard L Kaufman
BACKGROUND: Cutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response ≥6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). METHODS: Retrospective review of OPTiM identified patients with cutaneous head and neck melanoma given talimogene laherparepvec (n = 61) or GM-CSF (n = 26)...
December 2016: Head & Neck
https://www.readbyqxmd.com/read/27372293/systematic-review-of-the-use-of-granulocyte-macrophage-colony-stimulating-factor-in-patients-with-advanced-melanoma
#20
REVIEW
Christoph Hoeller, Olivier Michielin, Paolo A Ascierto, Zsolt Szabo, Christian U Blank
Several immunomodulatory checkpoint inhibitors have been approved for the treatment of patients with advanced melanoma, including ipilimumab, nivolumab and pembrolizumab. Talimogene laherparepvec is the first oncolytic virus to gain regulatory approval in the USA; it is also approved in Europe. Talimogene laherparepvec expresses granulocyte-macrophage colony-stimulating factor (GM-CSF), and with other GM-CSF-expressing oncolytic viruses in development, understanding the clinical relevance of this cytokine in treating advanced melanoma is important...
September 2016: Cancer Immunology, Immunotherapy: CII
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