- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Review, Journal: Delivery routes matter: Safety and efficacy of intratumoral immunotherapy. (Pubmed Central) - Jul 21, 2021
Moreover, it has been shown that intratumoral administration of immunostimulatory agents successfully synergizes with immune checkpoint inhibitor therapy. Here we review the current state of the art in (pre)clinical intratumoral immunotherapy.
- |||||||||| Review, Journal: Current status of intralesional agents in treatment of malignant melanoma. (Pubmed Central) - Jul 20, 2021
This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors (clinicaltrials.gov) - Jul 14, 2021
P2, N=19, Active, not recruiting,
Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents. Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Treatment Options for Advanced Melanoma After Anti-PD-1 Therapy. (Pubmed Central) - Jul 14, 2021
Currently available treatment options include BRAF-targeted and MEK inhibitor-targeted therapies for those with BRAFV600 mutant melanoma, while for patients with BRAF-WT melanoma or those who have already received prior BRAF-targeted therapy, options include anti-CTLA-4 therapy, alone or in combination with anti-PD-1 therapy, or for selected patients, clinical trials that may incorporate other immune checkpoint inhibitors or co-stimulatory agonists, oncolytic virotherapies, adoptive cellular therapies, or other novel agents. Participation in clinical trials is critical in order to delineate what more effective treatment options are and which group of patients after receiving prior anti-PD-1 therapy.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Review, Journal: The spontaneous remission of cancer: Current insights and therapeutic significance. (Pubmed Central) - Jul 10, 2021
Similarly, Talimogene laherparepvec (T-VEC), the first engineered oncolytic herpes simplex virus (HSV), has been approved by the United States Food and Drug Administration for the treatment of some forms of advanced melanoma. Here we describe the current understanding of SR, explore its therapeutic significance, and offer perspectives on its future.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Neoadjuvant Combination Immunotherapy for Stage III Melanoma (clinicaltrials.gov) - Jul 2, 2021
P2, N=28, Recruiting,
Altogether, Nectin-1 served as biomarker for T-VEC-induced melanoma regression in vitro and in vivo. Trial completion date: Mar 2024 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Jun 30, 2021
P1, N=16, Recruiting,
Trial completion date: Mar 2024 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022 Trial primary completion date: Apr 2021 --> Apr 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus: Recent advances of oncolytic virus in cancer therapy. (Pubmed Central) - Jun 22, 2021
An HSV-based oncolytic virus, T-VEC, has completed phase Ш clinical trial and has been approved by the U.S. Food and Drug Administration (FDA) for use in biological cancer therapy...In this review, we summarize the recent clinical advances in the use of oncolytic viruses in biological therapy for cancer. Additionally, this review evaluates the potential viral candidates for their benefits and shortcomings and sheds light on the future prospects.
- |||||||||| Review, Journal: Intratumoral Immunotherapy-Update 2019. (Pubmed Central) - Jun 22, 2021
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.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: Study of TVEC in Patients With Cutaneous Squamous Cell Cancer (clinicaltrials.gov) - Jun 21, 2021
P2, N=28, Recruiting,
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. Trial completion date: Sep 2021 --> Sep 2026 | Trial primary completion date: Mar 2021 --> Mar 2026
- |||||||||| canerpaturev (TBI-1401) / Takara
Review, Journal, Oncolytic virus: Oncolytic Viruses for the Treatment of Metastatic Melanoma. (Pubmed Central) - Jun 12, 2021
Data comparing T-VEC in combination with PD-1 checkpoint inhibitors is awaited, and a phase III trial is underway. It is likely that oncolytic viruses will have long-term application in the treatment of melanoma and that T-VEC in particular will continue to have a role in the treatment of patients with readily accessible cutaneous lesions both for local control and synergistic induction of antitumor immunity as part of combination therapies.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal: Recent and Emerging Therapies for Cutaneous Squamous Cell Carcinomas of the Head and Neck. (Pubmed Central) - Jun 12, 2021
Localized immunotherapies are also being studied, including oncolytic viruses such as talimogene laherparepvec, a modified herpes simplex virus previously approved for the treatment of advanced cutaneous melanoma. Most importantly, multidisciplinary care is crucial in optimizing outcomes for patients with high-risk cSCC of the head and neck.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Samcyprone (diphenylcyclopropenone) / Phio Pharma
Clinical, Clinical guideline, Journal: Locoregional management of in-transit metastasis in melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline. (Pubmed Central) - Jun 5, 2021
Evidence is insufficient to recommend intralesional bacille Calmette- Guérin or CO laser ablation outside of a research setting.■ In patients presenting with maximal itm confined to an extremity, isolated limb perfusion, isolated limb infusion, or systemic therapy may be considered. In extremely select cases, amputation could be considered as a final option in patients without systemic disease after discussion at a multidisciplinary case conference.■ In cases in which local, regional, or surgical treatments for itm might be ineffective or unable to be performed, or if a patient has systemic metastases at the same time, systemic therapy may be considered.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Measles virus in cancer therapy. (Pubmed Central) - Jun 4, 2021
A genetically modified herpesvirus, Talimogene laherparepvec, has already been authorized for the treatment of melanoma patients...Therefore, MeV has been introduced into 19 different clinical trials and has reached phase II against two different tumor entities, multiple myeloma and ovarian carcinoma. Remarkably, one patient with advanced stage myeloma experienced long-term remission after treatment, visualizing the potency of this approach.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases: TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - May 28, 2021
P1/2, N=46, Recruiting,
Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022 Trial primary completion date: Apr 2021 --> Apr 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma (clinicaltrials.gov) - May 24, 2021
P2, N=5, Active, not recruiting,
Trial primary completion date: Apr 2021 --> Apr 2022 Recruiting --> Active, not recruiting | N=15 --> 5 | Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: May 2021 --> Sep 2021
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Provenge (sipuleucel-T) / Bausch Health
Review, Journal: Monitoring T Cells Responses Mounted by Therapeutic Cancer Vaccines. (Pubmed Central) - May 4, 2021
More recently, T cell profiling has provided unprecedented detail on immune cell subsets and providing clues to the mechanism involved in immune activation. Here, we reviewed cancer vaccines currently in clinical trials and highlight available techniques in monitoring the clinical response in patients.
- |||||||||| Review, Journal, IO biomarker: Externally-Controlled Systems for Immunotherapy: From Bench to Bedside. (Pubmed Central) - May 1, 2021
In the present manuscript, we will review the different inducible, versatile and externally controlled gene delivery systems that have been developed and their applications to the field of immunotherapy. We will highlight the advantages and disadvantages of each system and their potential applications in clinics.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Talimogene laherparepvec with systemic immunotherapy in melanoma: A real-world experience. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_5438;
This is the largest single institution, real world experience to our knowledge, which assesses the efficacy of TVEC in combination with systemic immunotherapy . Our cohort suggests that TVEC is an effective treatment in combination with systemic immunotherapy, with a better overall survival observed with combination TVEC and anti-PD1 than seen with historical data from clinical trials of anti-PD-1 monotherapy.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] External validation of a Dutch predictive nomogram for complete response to T-VEC in an independent American patient cohort. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1868;
An independent dataset externally validated a recently published predictive nomogram for CR to T-VEC in stage IIIB-IVM1a melanoma, with both models resulting in overall performances that were comparable and good . The second model reinforces the conclusion that for the best response to T-VEC, it should be used early on in the course of the disease, when the patient’s tumor burden is cutaneous with smaller diameter and fewer of metastases.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] A phase 2 study of talimogene laherparepvec, nivolumab, and trabectedin (TNT) in advanced sarcoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1185;
P2
Furthermore, median PFS exceeded that of the immediately preceding lines of therapy in this heavily pre-treated cohort . As data matures, further data will be reported.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial termination, Trial primary completion date: KEYNOTE-034: Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma (clinicaltrials.gov) - Apr 22, 2021
P1b, N=713, Terminated,
As data matures, further data will be reported. Trial completion date: Apr 2023 --> Mar 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2022 --> Mar 2021
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Looking into a Better Future: Novel Therapies for Metastatic Melanoma. (Pubmed Central) - Apr 20, 2021
If the BRAF mutation status is positive, the combination of dabrafenib and trametinib could be an option to consider...New studies have opened up new avenues for future research in melanoma treatment, which is expected to lead to better therapeutic outcomes for our patients. The objective of this review is to discuss the novel therapies for metastatic melanoma that have been tested in humans during the last 3 years to obtain a sharper perspective of the available treatment options for specific patient characteristics.
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