- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Monotherapy: Talimogene laherparepvec monotherapy for head and neck melanoma patients. (Pubmed Central) - Dec 2, 2022
ORR for T-VEC monotherapy for melanoma in the head and neck region at our institute was 80% with 50% achieving a CR. This realworld data demonstrates promising results and suggests T-VEC can be an alternative to systemic therapy in this select, mostly elderly patient population.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Dec 1, 2022
P1, N=9, Active, not recruiting,
This realworld data demonstrates promising results and suggests T-VEC can be an alternative to systemic therapy in this select, mostly elderly patient population. Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Tumoral melanosis mimicking residual melanoma in the setting of talimogene laherparepvec treatment. (Pubmed Central) - Nov 4, 2022
Pathological evaluation demonstrated non-viable or absent tumor tissue with tumorous melanosis in all cases. To accurately assess response to therapy and potentially decrease unnecessary additional T-VEC treatments, serial biopsy of 'stable' lesions should be considered to assess the presence or absence of viable tumor.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial termination, Metastases: Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma (clinicaltrials.gov) - Nov 1, 2022
P2, N=5, Terminated,
The immunostimulatory effects of the viruses could be partially increased by chemotherapy, providing a rationale for future preclinical studies designed to explore T-VEC in combined regimens. Active, not recruiting --> Terminated; Sponsor Terminated Funding
- |||||||||| Review, Journal: Options of Therapeutics and Novel Delivery Systems of Drugs for the Treatment of Melanoma. (Pubmed Central) - Oct 29, 2022
Nanoparticles and liposomes have been emerging as advanced delivery systems which can improve drug stability and systemic circulation time. In this review, the most recent findings in the options for treatment and development of novel drug delivery systems for the treatment of melanoma are comprehensively discussed.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
Trial completion date: SOC-1882: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (clinicaltrials.gov) - Oct 17, 2022
P2, N=40, Recruiting,
Finally, we highlighted key challenges ahead to promote coordination and stimulate collaboration within the research community. Trial completion date: Dec 2022 --> Mar 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Immunotherapy-Induced Glomerulonephritis: Whodunit? (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1073;
Nivolumab was stopped and he was started on prednisone 60 mg daily and lisinopril...He was treated with rituximab 1 g weekly for 4 weeks, methylprednisolone IV 1 g daily for 4 days...Delayed onset kidney injury from nivolumab cannot be excluded or these findings could be due to T-VEC. T-VEC should be considered a possible cause of immune adverse events.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Metastases: TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - Oct 6, 2022
P1/2, N=46, Recruiting,
Interestingly, a high discrepancy was observed between the pre-surgical radiological imaging and the actual surgical pathological report. Suspended --> Recruiting
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Targeting CD73 in GBM sensitizes tumors to oncolytic virus therapy (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_694;
With the approval of oHSV Imlygic by FDA for metastatic melanoma and more recently, conditional approval of G47Δ, marketed by Daiichi Sankyo for GBM treatment in Japan, oncolytic viral therapy has emerged as a promising biological approach to treat solid tumors...Using mice with CD73 knocked out globally (CD73KO), we show that combination of CD73 inhibition with HSV-P10 imparts significant survival benefit compared to WT mice treated with HSV-P10. Our findings will further the understanding of oHSV therapy and the role of the ATP/adenosine in the tumor microenvironment.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
HSV-PTENA treatment targets glioma stem cells to reduce stemness and sensitizes glioblastoma to irradiation (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_672;
Among all OVs, oncolytic Herpes Simplex Virus (oHSV) is substantially ahead in the clinic, with an oHSV T-VEC approved by the FDA for metastatic melanoma treatment and G47∆ which received conditional approval for the treatment of GBM in Japan...HSV-P10 infection in combination with irradiation reduces GSC tumor sphere formation in vitro and sensitizes GBMs to radiotherapy in an intracranial mouse xenograft model. Our findings uncover a possible mechanism to overcome GSC-mediated therapy resistance to improve the therapeutic efficacy for GBM.
- |||||||||| 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) - Sep 26, 2022
P1, N=6, Active, not recruiting,
Our findings uncover a possible mechanism to overcome GSC-mediated therapy resistance to improve the therapeutic efficacy for GBM. Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2022 --> Jul 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Strategies for Advanced Oncolytic Virotherapy: Current Technology Innovations and Clinical Approaches. (Pubmed Central) - Sep 24, 2022
Representative drug Talimogene laherparepvec has showed promising therapeutic effects in advanced melanoma, especially when combined with immune checkpoint inhibitors with moderate adverse effects...This review introduces the latest progress in clinical trials and pre-clinical studies as well as technology innovations directed at oncolytic viruses. The challenges and perspectives of oncolytic virotherapy towards clinical application are also discussed.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Electrochemotherapy of skin metastases from malignant melanoma: a PRISMA-compliant systematic review. (Pubmed Central) - Sep 20, 2022
The main treatment of MM metastases are systemic therapies, surgery, limb perfusion, and intralesional talimogene laherparepvec...Two studies reported 29.2% and 41.6% incidence of necrosis. ECT is effective in terms of tumor response and tolerated in patients with skin metastases from MM, albeit with a wide variability of reported results. Therefore, prospective trials in this setting are warranted.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) - Sep 10, 2022
P=N/A, N=920, Recruiting,
Trial completion date: Jan 2025 --> Jul 2023 Trial completion date: Sep 2027 --> Aug 2032 | Trial primary completion date: Sep 2027 --> Aug 2032
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
PHASE 2 COMBINATION REGIMEN WITH TALIMOGENE LAHERPAREPVEC (TVEC), NIVOLUMAB AND TRABECTEDIN FOR ADVANCED LEIOMYOSARCOMA [NCT# 03886311] () - Sep 9, 2022 - Abstract #CTOS2022CTOS_410;
Trial completion date: Sep 2027 --> Aug 2032 | Trial primary completion date: Sep 2027 --> Aug 2032 These results suggest that (1) The combination regimen using Talimogene Laherparepvec (TVEC), Nivolumab & Trabectedin is an effective second/third-line therapy for advanced leiomyosarcoma with manageable toxicity, (2) Response is not related to PD_L1 positivity and (3) The best responders are patients with ER+/PR+ uterine LMS.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
AN UPDATE ON TNT: A PHASE-2 STUDY OF THE EFFICACY AND SAFETY OF TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, AND TRABECTEDIN IN ADVANCED SARCOMA () - Sep 9, 2022 - Abstract #CTOS2022CTOS_225;
These results suggest that the second/third-line combination of Talimogene Laherparepvec (TVEC), Nivolumab & Trabectedin is a promising alternate second/third-line therapy in achieving disease control. There were no unexpected, or severe adverse events noted.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change: Study of TVEC in Patients With Cutaneous Squamous Cell Cancer (clinicaltrials.gov) - Sep 7, 2022
P2, N=11, Active, not recruiting,
There were no unexpected, or severe adverse events noted. Recruiting --> Active, not recruiting | N=28 --> 11
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Local anesthetics and immunotherapy: a novel combination to fight cancer. (Pubmed Central) - Sep 1, 2022
Intratumoral injection of oncolytic agents such as modified herpes simplex virus T-VEC or local administration of non-viral oncolytic therapies (such as radiofrequency, chemoembolization, cryoablation, or radiotherapy) can activate an anticancer immune response and hence trigger abscopal effects reducing secondary lesions...This may be explained by direct cytotoxic activity of local anesthetics and additional immune-related abscopal effects. We also summarize the molecular and cellular mechanisms by which the combination of local anesthetics and immunotherapy improves tumor control by the immune system.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial suspension, Metastases: TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - Aug 19, 2022
P1/2, N=46, Suspended,
Safety results of the T-VEC-pembrolizumab combination were consistent with the safety profiles of each agent alone. Recruiting --> Suspended
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Talimogene laherparepvec resulting in near-complete response in a patient with treatment-refractory Merkel cell carcinoma. (Pubmed Central) - Aug 18, 2022
Disease that reaches a more advanced stage can be treated with a variety of different treatment modalities including surgery, radiotherapy, chemotherapy, radionuclide therapy, immunotherapy, and intralesional therapy. We report a case of a patient who had exhausted all local and systemic treatment options and who subsequently had an exceptional response to intralesional injection of Talimogene laherparepvec (TVEC).
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Herpes simplex virus 1 as an oncolytic viral therapy for refractory cancers. (Pubmed Central) - Aug 17, 2022
Furthermore, this review focuses on the advantages and limitations in the use of T-VEC compared to other HSV-1 OV variants currently in clinical trials. In addition, approaches for future directions of HSV-1 OVs as cancer therapy is discussed.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Aug 4, 2022
P1, N=9, Active, not recruiting,
The safety profile was consistent with the patients' underlying disease and the known safety profile of T-VEC. Trial primary completion date: Apr 2022 --> Dec 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus: Radiofrequency Hyperthermia Enhances Locally Delivered Oncolytic Immuno-Virotherapy for Pancreatic Adenocarcinoma. (Pubmed Central) - Jul 31, 2022
Trial primary completion date: Apr 2022 --> Dec 2022 RFH enhances locally delivered oncolytic immuno-virotherapy for pancreatic adenocarcinoma, with decreased cell viability and increased apoptosis observed after combination therapy in vitro, and decreased cell viability and tumor volume and increased immune cell infiltrate observed after combination therapy in vivo.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Preclinical, Journal, PD(L)-1 Biomarker, IO biomarker: Combination immunotherapy including OncoVEX creates a favorable tumor immune micro-environment in transgenic BRAF murine melanoma. (Pubmed Central) - Jul 23, 2022
In summary, treatment with combination BRAFi + anti-PD1 + OncoVEX is more effective than any single treatment in controlling tumor growth, and groups receiving OncoVEX had more tumoral infiltration of CTLs and less intratumoral Tregs in the TIME. This study provides rational basis to combine targeted agents, oncolytic viral therapy, and checkpoint inhibitors in the treatment of melanoma.
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