- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal: False positive FDG uptake in melanoma patients treated with talimogene laherparepvec (T-VEC). (Pubmed Central) - Nov 11, 2021
In current clinical practice, physicians should be aware of the high false positive rate of FDG uptake during treatment with T-VEC in patients with melanoma. Therefore, pathological examination of lymph node lesions with new FDG uptake is recommended to differentiate between progressive disease and immune infiltration after treatment with T-VEC.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Oncolytic Virotherapy for Melanoma Brain Metastases, a Potential New Treatment Paradigm? (Pubmed Central) - Oct 25, 2021
Evidence for oncolytic virotherapy treatment of melanoma is limited primarily to T-VEC, with a noticeable paucity of data in the literature with respect to brain tumor metastasis. Given the promising findings of virotherapy for other brain tumor types, oncolytic virotherapy has great potential to offer benefits to patients afflicted with melanoma brain metastases and warrants further investigation.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Oncolytic herpes simplex virus type-1 expressing IL-12 efficiently replicates and kills human colorectal cancer cells. (Pubmed Central) - Oct 22, 2021
An increasing attitude towards oncolytic viruses (OVs) is witnessed following T-VEC's approval...INF-γ production and PBMC proliferation were observed in the PBMCs treated with the lysate of Δ47/Δ34.5/IL12 infected cells. These results demonstrated that Δ47/Δ34.5/IL12 was competent in taking advantage of the cytotoxic effect of HSV-1 plus immune-stimulatory characteristics of IL-12.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: TEMPO: Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (clinicaltrials.gov) - Oct 21, 2021
P1, N=24, Recruiting,
These results demonstrated that Δ47/Δ34.5/IL12 was competent in taking advantage of the cytotoxic effect of HSV-1 plus immune-stimulatory characteristics of IL-12. Trial completion date: Sep 2022 --> Mar 2022 | Trial primary completion date: Sep 2021 --> Mar 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus, IO biomarker: The discovery and development of oncolytic viruses: are they the future of cancer immunotherapy? (Pubmed Central) - Oct 16, 2021
They tend to target cellular and host physiology as opposed to specific genetic alterations, which potentially enables broad responsiveness. The biological complexity of OVs have hindered their translation; however, the recent approval of talimogene laherparepvec (T-Vec) has invigorated the field.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus, IO biomarker: Oncolytic virus therapy in cancer: A current review. (Pubmed Central) - Oct 12, 2021
The success of therapies using OVs was initially demonstrated by the use of the genetically modified herpes virus, talimogene laherparepvec, for the treatment of melanoma...However, it is necessary to be aware of the safety and possible adverse effects of this therapy; after all, an effective treatment for cancer should promote regression, attack the tumor, and in the meantime induce minimal systemic repercussions. In this manuscript, we will present a current review of the mechanism of action of OVs, main clinical uses, updates, and future perspectives on this treatment.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Growth, Purification, and Titration of Oncolytic Herpes Simplex Virus. (Pubmed Central) - Oct 6, 2021
Because of these unique properties, oHSV-based treatment strategies are being increasingly used for the treatment of cancer, preclinically and clinically, including FDA-approved talimogene laherparevec (T-Vec)...Following purification, the number of infectious oHSV (designated as plaque-forming units or PFUs) is determined by a "plaque assay" in Vero cells. The protocol described herein can be used to prepare high-titer oHSV stock for in vitro studies in cell culture and in vivo animal experiments.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Resistance to oncolytic vaccinia can be reversed by targeting regulatory T cells with vaccinia-directed delivery of a TGFβ inhibitor (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_555;
However, apart from the oncolytic HSV T-vec, these therapies have not seen widespread use, due in part to incomplete understanding of their immunologic mechanisms of action...Our data highlight the importance of Treg cell status in resistance to oncolytic virus therapy and suggest TGFβ can be effectively targeted through an inhibitor encoded within the virus. Importantly, this TME directed production of the TGFβi carries no toxicity previously associated with systemic TGFβ inhibition, suggesting a viral approach to TGFβ inhibition can be an effective strategy support broader immunotherapy response.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Preclinical, Journal: Antitumor immunity enhancement through Newcastle viral oncolysate in mice model: A promising method to treat tumors. (Pubmed Central) - Oct 1, 2021
Also, our major findings are that the peritumorally injection of NDV oncolysate effectively induces antitumor immune responses through increased levels of IL-4, IFN-γ, and reduction of IL-10. These results indicate that this treatment is a specific, active immune mechanism stimulator, and may prove to be a useful therapeutic for a treatment against cervical cancers and merits further investigation.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion: Registry Study for Talimogene Laherparepvec (clinicaltrials.gov) - Sep 30, 2021
P=N/A, N=185, Completed,
No abstract available Active, not recruiting --> Completed
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus: Oncolytic virotherapy-mediated anti-tumor response: a single-cell perspective. (Pubmed Central) - Sep 30, 2021
Talimogene laherparepvec (T-VEC) is a genetically modified herpes simplex 1 virus (HSV-1) approved for cancer therapy...It also leads to interferon pathway activation and early influx of natural killer cells, monocytes, and dendritic cells. These events are followed by enrichment in cytotoxic T cells and a decrease of regulatory T cells in injected and noninjected lesions.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: The power to "di-sc-seq-t". (Pubmed Central) - Sep 22, 2021
In this issue of Cancer Cell, Ramelyte et al. show activity of T-VEC in cutaneous B cell lymphoma and demonstrate, using scRNA-seq, that viral replication occurs not only in tumor cells.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Registry Study for Talimogene Laherparepvec (clinicaltrials.gov) - Sep 21, 2021
P=N/A, N=185, Active, not recruiting,
show activity of T-VEC in cutaneous B cell lymphoma and demonstrate, using scRNA-seq, that viral replication occurs not only in tumor cells. Enrolling by invitation --> Active, not recruiting | N=340 --> 185 | Trial completion date: Jan 2023 --> Sep 2021 | Trial primary completion date: Jan 2023 --> Sep 2021
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Last-line therapy success with the combination of lenvatinib and pembrolizumab in metastatic melanoma (Stream 4) - Sep 20, 2021 - Abstract #ADO2021ADO_394;
Subsequently, progressive filia appeared again, which is why cytostatic therapy with dacarbazine was carried out...The disease control rate of 65% shown is also quite good for this patient group. The combination therapy with lenvatinib and pembrolizumab has been well tolerated by the patient since 02/21 and after only 2 months of therapy there were clearly regressive metastases and in some cases CR in all organ systems.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Neospora caninum: a new class of biopharmaceuticals in the therapeutic arsenal against cancer. (Pubmed Central) - Sep 19, 2021
These results highlight N. caninum as a potential, extremely effective and non-toxic anticancer agent, capable of being engineered to either express at its surface or to secrete biodrugs. Our work has identified the broad clinical possibilities of using N. caninum as an oncolytic protozoan in human medicine.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Oncolytic HSV Vectors and Anti-Tumor Immunity. (Pubmed Central) - Sep 11, 2021
Oncolytic herpes simplex viruses (oHSVs) are among the most widely studied OVs for the treatment of solid malignancies, and Amgen's oHSV Imlygic® for the treatment of melanoma is the only OV approved in major markets. Here we describe important biological features of HSV that make it an attractive OV, clinical experience with HSV-based vectors, and strategies to increase applicability to cancer treatment.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal: A Case of Recurrent Malignant Melanoma of the Left Foot with In-Transit Metastases. (Pubmed Central) - Sep 3, 2021
He then received consistent follow-up including blood work and PET scans every four months, and he also required further lymph node surgical dissection. To date, our patient has survived 3 years and 11 months, which is 27 months longer than the esti- mated median survival of 1 year 8 months for patients diagnosed with in-transit metastatic melanoma.
- |||||||||| napabucasin (BBI608) / Sumitomo Dainippon, Boston Pharma
Preclinical, Journal, IO biomarker: The synergistic anticancer effects of ReoT3D, CPT-11, and BBI608 on murine colorectal cancer cells. (Pubmed Central) - Aug 29, 2021
The present study highlights that combination of ReoT3D, CPT-11, and BBI560 showed synergistic anticancer activity against CT26 cell line. This modality might be considered as a new approach against colorectal cancer (CRC) in the in vivo and clinical trial investigations.
- |||||||||| NICE, Reimbursement, Review, Journal: Evaluation of Advanced Therapy Medicinal Products by the National Institute for Health and Care Excellence (NICE): An Updated Review. (Pubmed Central) - Aug 21, 2021
There were ten gene therapy products (talimogene laherparepvec [TA410], strimvelis [HST7], tisagenlecleucel [TA554 and TA567], axicabtagene ciloleucel [TA559], voretigene neparvovec [HST11], autologous anti-CD19-transduced CD3+ cells [TA677], betibeglogene autotemcel [ID968], onasemnogene abeparvovec [HST15] and OTL-200 [ID1666]), one tissue engineered product (holoclar [TA467]) and three somatic cell therapy products (darvadstrocel [TA556] and autologous chondrocyte implantation [ACI] [TA477 and TA508])...In conclusion, the challenges raised by the economic appraisal of ATMPs, albeit not unique, may be exacerbated by the uncertainty related to the often scant evidence base. Adaptations of the conventional decision-making process rather than completely new methods may improve appraisals of ATMPs.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, 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) - Aug 18, 2021
P1, N=6, Active, not recruiting,
No abstract available Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion) (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=15, Completed,
Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022 Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Aug 2021 | Trial primary completion date: Aug 2022 --> Aug 2021
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Injectable Therapies for Regional Melanoma. (Pubmed Central) - Aug 14, 2021
Injectable or intralesional therapies can be part of multifaceted treatment strategies to kill tumor directly or to alter the tumor so as to make it more sensitive to systemic therapy. Talimogene laherparepvec is the only Food and Drug Administration-approved injectable therapy currently in wide clinical use in the United States, although ongoing trials are evaluating novel intralesional agents as well as combinations with systemic therapies, particularly checkpoint inhibitors.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal: Successful Treatment of In-Transit Metastatic Melanoma in a Renal Transplant Patient With Combination T-VEC/Imiquimod Immunotherapy. (Pubmed Central) - Jul 24, 2021
In solid organ transplant patients who lack surgical options and are not eligible for treatment with a BRAF inhibitor, and for whom treatment with checkpoint inhibitors present risk of organ rejection, T-VEC either alone or in combination with topical imiquimod should be considered for patients with locally advanced disease. This combination should be a consideration, with close observation, in patients with a history of organ transplantation and immunosuppression.
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