- |||||||||| Reolysin (pelareorep) / Oncolytics, Andrus Reo
Review, Journal, Oncolytic Virus: Past, Present and Future of Oncolytic Reovirus. (Pubmed Central) - Nov 5, 2020 This article will provide an unbiased review of oncolytic reovirus (clinically formulated as pelareorep), including the molecular and cellular requirements for reovirus oncolysis and anti-tumour immunity, reports of pre-clinical efficacy and its overall clinical trajectory. Moreover, as it is now abundantly clear that the true potential of all OVs, including reovirus, will only be reached upon the development of synergistic combination strategies, reovirus combination therapeutics will be discussed, including the limitations and challenges that remain to harness the full potential of this promising therapeutic agent.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed, Tumor mutational burden, IO biomarker, Metastases: S1607: Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov) - Nov 5, 2020 P2, N=47, Active, not recruiting, Moreover, as it is now abundantly clear that the true potential of all OVs, including reovirus, will only be reached upon the development of synergistic combination strategies, reovirus combination therapeutics will be discussed, including the limitations and challenges that remain to harness the full potential of this promising therapeutic agent. Recruiting --> Active, not recruiting
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic Virus: OvirusTdb: A database of oncolytic viruses for the advancement of therapeutics in cancer. (Pubmed Central) - Oct 21, 2020 Recently, the FDA approved an oncolytic virus T-vec for the treatment of melanoma...Nearly, 3243 and 1506 records indicate cancer cell death via apoptosis induction and immune activation, respectively. OvirusTdb may facilitate researchers in designing and discovering new oncolytic viruses for effective cancer treatment.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: An Evaluation of Talimogene Laherparepvec for the Treatment of Melanoma. (Pubmed Central) - Oct 16, 2020 Clinical applications will likely increase as more data become available on its use in the neoadjuvant setting and in combination with other systemic immune therapies. We expect the fields of intralesional therapy and viral oncotherapy to expand as we better understand how to manipulate the tumor microenvironment and host immune response to cancer.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] Tumoral Melanosis Mimicking Residual Melanoma After T-VEC Treatment () - Oct 14, 2020 - Abstract #SITC2020SITC_1619; Conclusions In patients receiving T-VEC treatment, pathologic CR may be achieved within the first 2–3 months, which precedes clinical improvement of pigmentation. To decrease unnecessary additional T-VEC treatment and assess the response correctly, serial biopsy of stable pigmented lesions should be considered to assess for the presence or absence of viable tumor.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
[VIRTUAL] Tumoral Melanosis Mimicking Residual Melanoma After T-VEC Treatment () - Oct 14, 2020 - Abstract #SITC2020SITC_884; Conclusions In patients receiving T-VEC treatment, pathologic CR may be achieved within the first 2–3 months, which precedes clinical improvement of pigmentation. To decrease unnecessary additional T-VEC treatment and assess the response correctly, serial biopsy of stable pigmented lesions should be considered to assess for the presence or absence of viable tumor.
- |||||||||| Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma (clinicaltrials.gov) - Oct 12, 2020
P1b, N=4, Active, not recruiting, Results N/A Conclusions This study will test the safety, tolerability, and preliminary clinical activity of IP TL; the results will be relevant to inform future investigations of local oncoimmunotherapies in patients with PSD, a highly unmet need population that currently has limited therapeutic options. Recruiting --> Active, not recruiting | N=20 --> 4 | Trial primary completion date: Jun 2020 --> Nov 2020
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Observational data, Retrospective data, Journal, Real-World Evidence: Real-world use of talimogene laherparepvec in Germany: a retrospective observational study using a prescription database. (Pubmed Central) - Oct 7, 2020 This real-world prescription database study showed that patients who initiated treatment in 2017 had a treatment duration in clinical practice that corresponded with the European Summary of Product Characteristics guideline of continuing T-VEC for ≥6 months. Additional long-term data linking drug use with clinical outcomes are needed.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] Complete remission after a combination of PD-1 immunotherapy and oncolytic viruses (ePoster Terminal 2) - Sep 20, 2020 - Abstract #ADO2020ADO_161; The resulting deficiency of melanocyte ‐ stimulating hormone and the immune response against the melanocytes probably caused the progressive vitiligo. This raises questions about a meaningful immunotherapy sequence and the prognostic value of post-therapeutic vitiligo.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Effectiveness of intralesional talimogen Laherparepvec and systemic PD-1 antibody therapy after progress under adjuvant PD-1 antibody therapy in malignant melanoma: 3 case reports (ePoster Terminal 2) - Sep 20, 2020 - Abstract #ADO2020ADO_131; The combination of pembrolizumab with T-VEC or placebo has already been investigated in patients with AJCC stage IIIB-IVM1d as part of the Masterkey-265 study in the first-line situation; the results are still pending...The first patient also had lung metastasis (M1b), so that a combined immunotherapy with ipilimumab and nivolumab was initiated...Summary: After a progression under adjuvant PD-1 antibody therapy, a combination of T-VEC and PD-1 antibody therapy is possible continues to be a sensible treatment option. In a phase II study, this situation is precisely what happens in patients with not Resectable or metastatic melanoma in AJCC stage IIIB ‐ IVM1d that had progressed under previous PD ‐ 1 antibody therapy was examined (Masterkey ‐ 115).
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: An update on GM-CSF and its potential role in melanoma management. (Pubmed Central) - Sep 16, 2020 Although GM-CSF has been injected into tumors for many years, the efficacy of this has not been tested. There is a strong rationale for GM-CSF as a vaccine adjuvant, but it appears of benefit only for strategies that directly involve DCs, such as intratumor talimogene laherparepvec and vaccines in which DCs are loaded with antigen ex vivo and injected admixed with GM-CSF.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: Neoadjuvant Combination Immunotherapy for Stage III Melanoma (clinicaltrials.gov) - Sep 9, 2020 P2, N=28, Recruiting, There is a strong rationale for GM-CSF as a vaccine adjuvant, but it appears of benefit only for strategies that directly involve DCs, such as intratumor talimogene laherparepvec and vaccines in which DCs are loaded with antigen ex vivo and injected admixed with GM-CSF. Not yet recruiting --> Recruiting
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic Virus, PD(L)-1 Biomarker, IO Biomarker: Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. (Pubmed Central) - Aug 30, 2020 P1/2 For clinical use, these viruses are expected to be most effective in combination with other anti-cancer agents, in particular PD1/L1-targeted immune checkpoint blockade. The first virus from this program (expressing GALV-GP-R and hGM-CSF) has entered clinical development alone and in combination with anti-PD1 therapy in a number of tumor types (NCT03767348).
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Innovative Therapeutic Approaches in Primary Cutaneous B Cell Lymphoma. (Pubmed Central) - Aug 28, 2020 Newer options are monoclonal anti-CD40 antibody dacetuzumab, anti-PD-1 and anti-PD-L1 checkpoint inhibitors, and Bruton tyrosine kinase inhibitors...In aggressive PCDLCBCL, LT, rituximab with polychemotherapy is recommended. Innovative therapies include intralesional oncolytic virotherapy, systemic monoclonal antibodies, and small molecules.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) - Aug 27, 2020 P1b, N=36, Active, not recruiting, Innovative therapies include intralesional oncolytic virotherapy, systemic monoclonal antibodies, and small molecules. Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: Aug 2020 --> Jan 2021
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Combination therapy, Metastases: TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion) (clinicaltrials.gov) - Aug 23, 2020 P1/2, N=15, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: Aug 2020 --> Jan 2021 Recruiting --> Active, not recruiting
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