- |||||||||| 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 19, 2022
P2, N=28, Recruiting,
Trial completion date: Mar 2022 --> Jun 2027 | Trial primary completion date: Mar 2022 --> Jun 2024
- |||||||||| Oncorine (recombinant human adenovirus type 5) / Mergen Ltd.
Review, Journal, Oncolytic virus: Advances in the clinical development of oncolytic viruses. (Pubmed Central) - Jul 17, 2022
OVs exhibit accurate oncolysis and favorable safety, and have positive effects on a variety of tumor treatments. It is worth noting that most of the OVs under development are still in their early stages, which is both a challenge and a promising prospect.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Novel biomarkers for oncolytic virotherapy (Poster Area) - Jun 28, 2022 - Abstract #EACR2022EACR_262;
The cultures were screened for sensitivity towards 5 OVs from different virus families currently investigated in clinical trials (measles virus, parvovirus, reovirus, adenovirus and the EMA-approved OV talimogene laherparepvec)...Conclusion Our findings illustrate the sensitivity spectrum of primary PDAC cultures towards OVs and thus underline the need for pre-therapeutic patient stratification. To this end, our project delivers a broad, descriptive, and comparative gene expression profiling data set, which provides a rich source of biomarker candidates warranting future validation.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, Oncolytic virus: Beyond Immunotherapy: Seizing the Momentum of Oncolytic Viruses in the Ideal Platform of Skin Cancers. (Pubmed Central) - Jun 25, 2022
Despite these results, numerous studies are currently active, evaluating T-VEC and several other OVs as monotherapies or in regimens with ICIs in different subtypes of skin cancer. This overview provides a comprehensive update on the evolution status of all available OVs in melanoma and non-melanoma skin cancers and summarizes the more interesting preclinical findings, the latest clinical evidence, and the future insights in relation to the expected selective incorporation of some of these OVs into oncological practice.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Tumoral Melanosis and Separate Granulomatous Inflammation due to Talimogene Laherparepvec. (Pubmed Central) - Jun 22, 2022
This overview provides a comprehensive update on the evolution status of all available OVs in melanoma and non-melanoma skin cancers and summarizes the more interesting preclinical findings, the latest clinical evidence, and the future insights in relation to the expected selective incorporation of some of these OVs into oncological practice. No abstract available
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Biomarker, Trial primary completion date: Neoadjuvant T-VEC in High Risk Early Melanoma (clinicaltrials.gov) - Jun 21, 2022
P2, N=62, Recruiting,
In conclusion, single agent T-VEC achieves the highest response rates in patients with early metastatic melanoma and is well-tolerated with generally only mild toxicities. Trial primary completion date: May 2022 --> Dec 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Monotherapy: Re-introduction of T-VEC Monotherapy in Recurrent Melanoma is Effective. (Pubmed Central) - Jun 11, 2022
Response to re-introduction of T-VEC monotherapy in this select patient population is promising. This real world data on re-introduction of T-VEC monotherapy in stage IIIB/C-IVM1a melanoma suggests T-VEC could be a treatment option for chronic disease control.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Trial completion date, Trial primary completion date: KAPVEC: Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma (clinicaltrials.gov) - Jun 10, 2022
P2, N=20, Recruiting,
These findings suggest combining virotherapy with diverse molecular therapeutics for the treatment of NC. Not yet recruiting --> Recruiting | Trial completion date: Mar 2022 --> Feb 2024 | Trial primary completion date: Jan 2022 --> Feb 2023
- |||||||||| Journal, Tumor Mutational Burden, PARP Biomarker, PD(L)-1 Biomarker, IO biomarker: Progress and pitfalls in the use of immunotherapy for patients with triple negative breast cancer. (Pubmed Central) - Jun 8, 2022
However, question marks and difficulties remain; these include the identification of predictive biomarkers to select patients who benefit from the addition of PD1-blockade and the balance between efficacy and long-term toxicity for an individual patient. Numerous treatment combinations and new immunotherapeutic strategies beyond PD1 blockade are being evaluated, thus reflecting a promising evolution of a more personalized approach, and extended clinical benefit in TNBC.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Monotherapy: Complete response of Merkel cell carcinoma with talimogene laherparepvec (TVEC) monotherapy. (Pubmed Central) - May 9, 2022
Although TVEC therapy is currently approved for the treatment of advanced stage melanoma, it is still being investigated in MCC. This case supports the use of TVEC as monotherapy in select patients with locally advanced MCC who are not candidates for surgery or systemic immunotherapy.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases: TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - May 6, 2022
P1/2, N=46, Recruiting,
This case supports the use of TVEC as monotherapy in select patients with locally advanced MCC who are not candidates for surgery or systemic immunotherapy. Trial primary completion date: Apr 2022 --> Apr 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Role of Virus-Directed Therapy in Soft Tissue Sarcoma. (Pubmed Central) - Apr 30, 2022
This review mainly focuses on collective clinical data highlighting the role of OVs as immunotherapy being used in soft tissue sarcoma (STS) and bone sarcomas. Combining OVs with T cell-activating checkpoint inhibition, adoptive cell therapy or targeted therapies may yield increased potency, improve antitumor efficacy of oncolytic virotherapy, and offer a new prospect for the treatment of sarcoma.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Oncolytic viruses in melanoma. (Pubmed Central) - Apr 22, 2022
Currently, talimogene laherparepvec (T-VEC), a modified herpes virus, is FDA-approved in this population, with many other oncolytic viruses under investigation in both preclinical and trial settings. Herein, we detail the scientific rationale, current landscape, and future directions of oncolytic viruses in melanoma.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: The use of oncolytic virotherapy in the neoadjuvant setting. (Pubmed Central) - Apr 20, 2022
One of these immunotherapies is oncolytic virotherapy, whose clinical use has exploded with the Food and Drug Administration approval of Talimogene Laherparepvec. This review summarizes both the preclinical and clinical literature examining the use of oncolytic virotherapy in the neoadjuvant setting for different types of cancers and discusses some of the major questions that still need to be addressed in order for this unique use of immunotherapy to become clinically viable.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) - Apr 18, 2022
P=N/A, N=920, Recruiting,
Further research is required to establish whether HPD is a biologically distinct phenomenon and whether a theoretical risk of HPD should influence patient management. Trial completion date: Aug 2026 --> Sep 2027 | Trial primary completion date: Aug 2026 --> Sep 2027
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Tecentriq (atezolizumab) / Roche
Enrollment closed, Trial primary completion date: PROMETEO: Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer (clinicaltrials.gov) - Apr 11, 2022
P1, N=28, Active, not recruiting,
Trial completion date: Aug 2026 --> Sep 2027 | Trial primary completion date: Aug 2026 --> Sep 2027 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Apr 8, 2022
P1, N=9, Active, not recruiting,
Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2024 Recruiting --> Active, not recruiting | N=16 --> 9
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: In-transit metastatic cutaneous melanoma: current management and future directions. (Pubmed Central) - Apr 2, 2022
Where intraarterial perfusion based therapies have been shown to successfully treat extremity disease, injectable therapies can be used in lesions of the head and neck. Although systemic therapies for in-transit melanoma have limited specific data to support their primary use for in-transit disease, there are patients who may not be eligible for any of the other options, and current clinical trials are exploring the use of concurrent and sequential use of regional and systemic therapies with early results suggesting a synergistic benefit for oncologic response and outcomes.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment change, Trial completion date, Trial primary completion date, Surgery, Metastases: Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (clinicaltrials.gov) - Mar 24, 2022
P1, N=3, Active, not recruiting,
Moreover, the current study surmises that the affinity maturation of HAdV3 L5 can enhance virus attachment with all the receptors of cancer cells. N=21 --> 3 | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: TEMPO: Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (clinicaltrials.gov) - Mar 23, 2022
P1, N=24, Recruiting,
N=21 --> 3 | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2022 Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jul 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Metastases: T-VEC in Non-melanoma Skin Cancer (clinicaltrials.gov) - Mar 18, 2022
P1, N=26, Completed,
Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jul 2022 Trial completion date: Dec 2021 --> Mar 2022
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, IO biomarker: Talimogene Laherparepvec: Moving From First-In-Class to Best-In-Class. (Pubmed Central) - Mar 12, 2022
Further, strategies to identify predictive biomarkers of therapeutic response to T-VEC will be discussed. Finally, a brief outline of high-priority future directions for investigation of T-VEC and other promising oncolytic viruses will set the stage for a best-in-class oncolytic virus to bring the maximum benefit of this emerging class of anti-cancer agents to patients with cancer.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Seprehvir (HSV1716) / Sorrento
PTEN-L expressing HSV induces glioma stem cell differentiation and sensitizes glioblastoma to radiation in mice. (Section 18) - Mar 9, 2022 - Abstract #AACR2022AACR_2347;
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...Further, several other oHSVs including G207 and HSV1716 are currently being tested for safety and efficacy against GBM...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. Collectively, our findings provide a potential avenue to overcome GSC-mediated therapy resistance to improve the therapeutic efficacy for GBM patients.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus, IO biomarker: Oncolytic virotherapy as promising immunotherapy against cancer: mechanisms of resistance to oncolytic viruses. (Pubmed Central) - Mar 1, 2022
Although the history of using viruses goes back to the early 20th century, the approval of talimogene laherparepvec (T-VEC) in 2015 increased interest in oncolytic viruses (OVs)...Furthermore, the localization of receptors of viruses in the tight junctions, interferon responses, and the aberrant expression of genes involved in the cell cycle of the virus, including their infection and replication, reduce the efficacy of OVs. In this review, we present different mechanisms of resistance to OVs and strategies to overcome them.
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