Imlygic (talimogene laherparepvec) News

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|||||||||| Imlygic (talimogene laherparepvec) / Amgen
P1 data, Journal, Metastases: Phase I study of intratumoral injection of talimogene laherparepvec for the treatment of advanced pancreatic cancer. (Pubmed Central) - Jan 31, 2025
P1
Our findings underscore the feasibility of intratumoral T-VEC administration in advanced PDAC. Further investigation, particularly in combination with immunotherapies administered systemically is warranted to more optimally assess T-VEC in this challenging malignancy.ClinicalTrials.gov Identifier: NCT03086642.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
P2 data, Journal: Efficacy and tolerability of neoadjuvant therapy with Talimogene laherparepvec in cutaneous basal cell carcinoma: a phase II trial (NeoBCC trial). (Pubmed Central) - Jan 29, 2025
P2
Together, neoadjuvant T-VEC represents a viable treatment option for patients with difficult-to-resect basal cell carcinomas (EudraCT no. 2018-002165-19).

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Talimogene laherparepvec (T-VEC) as a treatment for melanoma: A systematic review. (Pubmed Central) - Jan 17, 2025
T-VEC effectively improves ORR and DRR in melanoma patients. However, further research is needed on combination therapy prospects and its adverse effects.

|||||||||| Review, Journal: Topical and Intralesional Treatments for Skin Metastases and Locoregionally Advanced Melanoma. (Pubmed Central) - Jan 12, 2025
Brief comments on other alternatives in development such as interferon-alpha, interleukin-12, ipilimumab and intralesional daromun are presented...It has also been described in a few papers that non-injected lesions may respond after the application of a local therapy in distant skin-metastases. Many of these intralesional treatments are being combined in different investigations with systemic immunotherapies, with the aim of obtaining synergic responses in those patients with refractory disease.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Clinical, Retrospective data, Review, Journal: Effectiveness and safety of talimogene laherparepvec and granulocyte-macrophage colony-stimulating factor for metastatic melanoma: a systematic review and network meta-analysis of randomized controlled trials. (Pubmed Central) - Jan 12, 2025
Nevertheless, due to the side effects and limitations, the clinical benefits of T-VEC therapy in metastatic melanoma should be interpreted cautiously. This network meta-analysis demonstrates that T-VEC may be a favorable choice of treatment for metastatic melanoma.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Retrospective data, Journal, IO biomarker: Genetic Factors Associated with Clinical Response in Melanoma Patients Treated with Talimogene Laherparapvec: A Single-Institution Retrospective Analysis. (Pubmed Central) - Dec 21, 2024
This network meta-analysis demonstrates that T-VEC may be a favorable choice of treatment for metastatic melanoma. This work describes the experience using T-VEC in melanoma at a single institution and highlights the presence of TERT promotor mutations as a possible driver of clinical response.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Retrospective data, Journal, Adverse events, Real-world evidence, Real-world: Safety of talimogene laherparepvec: a real-world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS). (Pubmed Central) - Dec 19, 2024
But safety signals were also be detected in 4 unexpected AEs (sepsis, encephalitis, syncope, and lymphadenopathy). Further clinical trials need to be undertaken to facilitate a more comprehensive comprehension of the safety profile of T-VEC.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis
Journal, IO biomarker: Adjuvant Radiation Therapy in Macroscopic Regional Nodal Melanoma. (Pubmed Central) - Dec 17, 2024
Generally, ART is now used at the first recurrence. The challenge now is to find which melanomas are truly radiosensitive if ART is to have any future role in this scenario.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Metastases: Talimogene laherparepvec (T-VEC) and Emerging Intralesional Immunotherapies for Metastatic Melanoma: A Review. (Pubmed Central) - Dec 14, 2024
In this review, we will provide an overview of intralesional therapies for melanoma with a particular focus on talimogene laherparepvec (T-VEC) and its future uses. We then discuss the landscape of current and emerging intralesional therapies.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Metastases: Advances in the management of regionally metastatic melanoma. (Pubmed Central) - Dec 11, 2024
There has been significant progress in recent years with intralesional agents such as Talimogene laherparepvec (T-VEC), PV-10 and TAVOkinase/electrocorporation as well as advances in infusional therapies such as percutaneous hepatic perfusion (PHP) for hepatic metastasis of ocular melanoma. This review evaluates advances in intralesional and infusional therapies for melanoma while limiting discussion to those therapies currently approved and on trial.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, IO biomarker, Surgery:  Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (clinicaltrials.gov) -  Nov 15, 2024
P2, N=40, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
This review evaluates advances in intralesional and infusional therapies for melanoma while limiting discussion to those therapies currently approved and on trial. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

|||||||||| Review, Journal: Breaking Barriers: Animal viruses as oncolytic and immunotherapeutic agents for human cancers. (Pubmed Central) - Nov 13, 2024
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 Notably, four leading contenders in this domain, Rigvir

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
TNT: A PHASE 2 STUDY USING TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, AND TRABECTEDIN FOR ADVANCED LEIOMYOSARCOMA AND LIPOSARCOMA NCT # 03886311) () - Nov 9, 2024 - Abstract #CTOS2024CTOS_484;
Notably, four leading contenders in this domain, Rigvir The data indicates that the combination regimen using Talimogene Laherparepvec, Nivolumab and Trabectedin may be more effective than Trabectedin alone (Median PFS 4.1 months) as treatment for previously treated patients with advanced leiomyosarcoma and liposarcoma with manageable toxicity.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
INTRALESIONAL ADMINISTRATION OF TALIMOGENE LAHERPAREPVEC T-VEC) INDUCES TUMOR REGRESSION IN PATIENTS WITH CUTANEOUS ANGIOSARCOMA () - Nov 9, 2024 - Abstract #CTOS2024CTOS_473;
Furthermore, we have shown that treatment induces a marked increase in immune infiltration, predominantly of CD8+ T cells. Despite low sample size (though concordant with the incidence of disease), we show a 40% pathologic complete response rate which suggests further exploration in a larger study is warranted.

|||||||||| EXPRESSION OF TRANSPOSABLE ELEMENTS AND IKZF1 PREDICTS IMMUNE INFILTRATES IN SARCOMAS AND CORRELATES WITH OUTCOMES AFTER IMMUNE CHECKPOINT INHIBITION () - Nov 9, 2024 - Abstract #CTOS2024CTOS_465;
In an initial heterogeneous cohort of sarcoma patients treated with ICI, we found that TE and IKZF1 expression predicted immune infiltrates, correlated with PFS, expression of inflammatory pathways, and increased in tumors which gained immune infiltrates during ICI treatment. In a second cohort from the TCGA, TE and IKZF1 expression again predicted immune infiltrates when controlling for subtype, correlated with inflammatory signaling pathway expression, and with OS.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
New P1 trial:  Neoadjuvant Intralesional Injection of Talimogene Laherparepvec (clinicaltrials.gov) -  Oct 28, 2024
P1, N=30, Not yet recruiting,  Sponsor: John Rieth

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Ultrasound-guided intra-tumoral administration of directly-injected therapies: a review of the technical and logistical considerations. (Pubmed Central) - Oct 26, 2024
This has relevance to cancer centres, radiology departments, individual radiologists, and other team members with a future role in meeting the emerging need for these procedures. This paper provides advice on developing such an imaging service, and offers certain insights into the evolving remit of radiologists within cancer care in the near future.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Intralesional Talimogene Laherparepvec Immunotherapy for Melanoma: A Case Study. (Pubmed Central) - Oct 21, 2024
Safety considerations and further investigations into potential interactions with other immunotherapies are warranted to optimize treatment strategies and ensure patient well-being. As oncolytic virotherapy continues to evolve, T-VEC stands as a potential option for the treatment of advanced melanoma.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date:  Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) -  Oct 7, 2024
P=N/A, N=300, Recruiting,  Sponsor: Amgen
As oncolytic virotherapy continues to evolve, T-VEC stands as a potential option for the treatment of advanced melanoma. Trial completion date: Aug 2038 --> Jan 2038 | Trial primary completion date: Aug 2038 --> Jan 2038

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Interim analysis of a phase II study of talimogene laherparepvec (T-VEC) followed by combination T-VEC + nivolumab in non-melanoma skin cancers and refractory cutaneous lymphoma (NCI#10057) (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1470;
Conclusions Analysis of data from Part I of this clinical trial suggests that T-VEC monotherapy did not translate to broad clinical efficacy across all tumor types, though may show activity in patients without visceral metastases. MCC and CSCC expansion cohorts (Part II) will be reported separately.View this table:View inline View popup Download powerpoint Abstract 621 Table 1 Best response to T-VEC monotherapyDownload figure Open in new tab Download powerpoint Abstract 621 Figure 1 Elderly female with at least 4 in-transit metastases from MCC on the left lower leg, who achieved a durable PR on T-VEC monotherapy

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
P2 data, Journal, Oncolytic virus: A phase II randomized trial of talimogene laherparepvec oncolytic immunotherapy with or without radiotherapy for patients with cutaneous metastases from solid tumors. (Pubmed Central) - Sep 28, 2024
Low overall response rate, slow accrual, and the COVID-19 pandemic led to closure of this trial. Responses in non-injected and non-irradiated metastases were infrequent.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Journal: Access to melanoma drugs in Spain: a cross-sectional survey. (Pubmed Central) - Sep 18, 2024
Responses in non-injected and non-irradiated metastases were infrequent. For most indications that reimbursement is restricted out of the EMA indication, a great diversity on access was found throughout the different hospitals in Spain, including heterogeneity intra-AACC.

|||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Beyond the Scalpel: Advancing Strategic Approaches and Targeted Therapies in Nonexcisable Melanomas. (Pubmed Central) - Sep 4, 2024
Future research should focus on refining existing treatments and exploring innovative modalities to enhance patient outcomes in the management of nonexcisable melanomas. Comprehensive guidelines and long-term efficacy studies are essential to optimize care and improve the quality of life for patients afflicted with melanoma in challenging anatomical locations.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Advances in Adjuvant and Neoadjuvant Therapy for Melanoma. (Pubmed Central) - Sep 2, 2024
Adjuvant therapy with immune checkpoint blockade (ICB) and targeted therapy with BRAF/MEK inhibitors (BRAF/MEKi) have now become standard of care for resectable stage IIIB-IV melanoma. In this article, the authors discuss recent scientific developments pertinent to the treatment of resectable melanoma including ICB, targeted therapy with BRAF/MEKi, oncolytic viruses, tumor-infiltrating lymphocyte therapy, and cancer vaccines.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Genetic Factors Associated with Clinical Response in Melanoma Patients Treated with Talimogene Laherparapvec: A Single-Institution Retrospective Analysis (Quick-Shot) (216_Level 2_South; In Person Only) - Aug 9, 2024 - Abstract #ACSCLINCON2024ACS_CLINCON_997;
This work describes the experience using T-VEC in melanoma at a single institution. These data could help select patients who would benefit from intralesional therapy.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Phase classification, Pan tumor, Metastases:  MASTERKEY318: Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 (clinicaltrials.gov) -  Aug 6, 2024
P1/2, N=127, Completed,  Sponsor: Amgen
These data could help select patients who would benefit from intralesional therapy. Phase classification: P1b/2 --> P1/2

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Oncolytic Viral Therapy for Non Melanoma Skin Cancers (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_2919;
However, existing studies are notably heterogeneous in the design, study population and response assessment, limiting generalizability. Robust evidence from phase 3 clinical trials demonstrating safety and efficacy of OVs is also lacking at present.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus, IO biomarker: Translation of oncolytic viruses in sarcoma. (Pubmed Central) - Jul 23, 2024
These studies have shown promising responses in heavily pre-treated and immunotherapy-resistant patients associated with increased intratumoral immune infiltration. As new and more potent OVs enter the clinical arena, prospective evaluation in subtype-specific cohorts with correlative studies to define biomarkers of response will be critical to advancing this promising approach for sarcoma therapy.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Metastases:  Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) -  Jul 9, 2024
P1, N=9, Active, not recruiting,  Sponsor: Karie D. Runcie, MD
As new and more potent OVs enter the clinical arena, prospective evaluation in subtype-specific cohorts with correlative studies to define biomarkers of response will be critical to advancing this promising approach for sarcoma therapy. Trial primary completion date: Dec 2023 --> Dec 2024

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Targeting Cancers with oHSV-Based Oncolytic Viral Immunotherapy. (Pubmed Central) - Jun 26, 2024
In this review, we discuss recent advances in the development of oncolytic HSV-1-based OViTs, their anti-tumor mechanism of action, and efficacy data from recent clinical trials. We envision this knowledge may be used to inform the rational design and application of future oHSV in cancer treatment.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Metastases: Intralesional and Infusional Updates for Metastatic Melanoma. (Pubmed Central) - Jun 19, 2024
In 2015, the Food and Drug Administration (FDA) approved the first oncolytic intralesional therapy, talimogene laherparepvec (T-VEC), for the treatment of advanced melanoma...While some of these treatments have less utility due to inferior outcomes as well as higher toxicity profiles, there are selective patient profiles for which these therapies carry a role. This review highlights intralesional and infusional therapies for the management of metastatic melanoma.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Metastases: Combined Regional Approach of Talimogene laherparepvec and Radiotherapy in the Treatment of Advanced Melanoma. (Pubmed Central) - Jun 19, 2024
However, we did not find a significant difference in locoregional recurrence or OS. Future studies are needed to assess the sequence and timing of combining RT and TVEC to potentially enhance the immune response both locally and distantly.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Vectibix (panitumumab) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Tumor mutational burden:  Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin (clinicaltrials.gov) -  Jun 14, 2024
P1, N=5, Active, not recruiting,  Sponsor: Rutgers, The State University of New Jersey
Future studies are needed to assess the sequence and timing of combining RT and TVEC to potentially enhance the immune response both locally and distantly. Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, IO biomarker:  NCI#10057: Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers (clinicaltrials.gov) -  Jun 6, 2024
P2, N=68, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025 Trial completion date: Jun 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Sep 2025

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Cytokine-armed oncolytic herpes simplex viruses: a game-changer in cancer immunotherapy? (Pubmed Central) - Jun 1, 2024
Talimogene laherparepvec is an oncolytic herpes simplex virus type 1 (oHSV), approved for the treatment of recurrent melanoma, and the virus encodes the human cytokine, granulocyte-macrophage colony-stimulating factor (GM-CSF)...In this review, we highlight preliminary data with several cytokines and chemokines, including GM-CSF, interleukin 12, FMS-like tyrosine kinase 3 ligand, tumor necrosis factor ?, interleukin 2, interleukin 15, interleukin 18, chemokine (C-C motif) ligand 2, chemokine (C-C motif) ligand 5, chemokine (C-X-C motif) ligand 4, or their combinations, and show how these payloads can further enhance the antitumor immunity of oHSV. A better understanding of cytokine delivery by oHSV can help improve clinical benefit from oncolytic virus immunotherapy in patients with cancer.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date:  Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) -  May 15, 2024
P=N/A, N=300, Recruiting,  Sponsor: Amgen
A better understanding of cytokine delivery by oHSV can help improve clinical benefit from oncolytic virus immunotherapy in patients with cancer. Trial completion date: Aug 2037 --> Aug 2038 | Trial primary completion date: Aug 2037 --> Aug 2038

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal: Comparison of the oncolytic activity of a replication-competent and a replication-deficient herpes simplex virus 1. (Pubmed Central) - May 6, 2024
When markers of immunogenic cell death were assessed, ATP was released more efficiently in the context of T-VEC than HSV-1 d106S infection, whereas HMGB1 was induced comparatively well. Overall, the early oncolytic effect on three different tumour entities was stronger with the non-replicative strain, while the replication-competent virus elicited a stronger innate immune response and more pronounced immunogenic cell death.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date:  Neoadjuvant Combination Immunotherapy for Stage III Melanoma (clinicaltrials.gov) -  May 1, 2024
P2, N=28, Recruiting,  Sponsor: University of Louisville
Overall, the early oncolytic effect on three different tumour entities was stronger with the non-replicative strain, while the replication-competent virus elicited a stronger innate immune response and more pronounced immunogenic cell death. Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Jun 2024 --> Jun 2026

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial termination, Surgery, Metastases:  Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (clinicaltrials.gov) -  May 1, 2024
P1, N=3, Terminated,  Sponsor: National Cancer Institute (NCI)
Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Jun 2024 --> Jun 2026 Active, not recruiting --> Terminated; Inadequate accrual rate

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Talimogene laherparepvec is an effective salvage therapy for advanced melanoma: a real-world study (Trinity Ballroom) - Apr 27, 2024 - Abstract #SID2024SID_691;

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Intralesional talimogene laherparepvec a novel approach for the immunoprevention of invasive cutaneous squamous cell carcinoma (De Soto) - Apr 27, 2024 - Abstract #SID2024SID_604;

|||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, J&J, Opdivo (nivolumab) / BMS
An update on SOC-1882: A phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin for advanced leiomyosarcoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6718;
P2
Taken together, the data confirms our previous report that (1) the combination regimen using Talimogene laherparepvec, Nivolumab & Trabectedin may be more effective and treatment for previously treated patients with advanced leiomyosarcoma with manageable toxicity, and (2) The best responders are patients with HR+ uterine LMS. Clinical trial information: NCT03886311.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Phase I trial of talimogene laherparepvec for the treatment of peritoneal surface malignancies (TEMPO). (Hall A; Poster Bd #: 147) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3068;
P1
TEMPO successfully identified 4x10 8 pfu as the RP2D for TVEC. Notably, the RMST increased with increasing doses of TL.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
SH2B3 mutation as a potential resistance mechanism to oncolytic virus therapy. (Hall A; Poster Bd #: 57) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2981;
This is the first study to report a possible genetic driver for OV resistance. We introduced using CRISPR-HDR P521L SH2B3 in MCC cell lines to investigate its impact on LNK expression and its role as a mechanism of OV treatment resistance, with results to be presented.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date:  SOC-1882: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (clinicaltrials.gov) -  Apr 18, 2024
P2, N=40, Recruiting,  Sponsor: Sarcoma Oncology Research Center, LLC
We introduced using CRISPR-HDR P521L SH2B3 in MCC cell lines to investigate its impact on LNK expression and its role as a mechanism of OV treatment resistance, with results to be presented. Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion, 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) -  Apr 11, 2024
P2, N=19, Completed,  Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Feb 2024 | Trial primary completion date: Jun 2024 --> Feb 2024

|||||||||| Oncorine (recombinant human adenovirus type 5) / Mergen Ltd.
Review, Journal, Oncolytic virus: New hopes for the breast cancer treatment: perspectives on the oncolytic virus therapy. (Pubmed Central) - Apr 9, 2024
Oncolytic virus therapy holds substantial potential in breast cancer treatment, demonstrating safety in trials. Multi-approach strategies combining OVs with conventional therapies exhibit more promising therapeutic effects than monotherapy, signalling a hopeful future for OV-based breast cancer treatments.

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Metastases: Current Role and Status for Intratumoral Injection Therapies in Metastatic Melanoma. (Pubmed Central) - Mar 29, 2024
In addition, a majority of intratumoral therapies have focused on stimulating antitumor immune responses, making them a particularly attractive option for use in melanoma. In this review, we describe applications for talimogene laherparepvec, a US Food and Drug Administration-approved intratumoral therapy in melanoma, as well as several classes of intratumoral therapies in development including novel oncolytic viruses, mRNA-based intratumoral injections, and cytokines and other signaling molecules.

||||||||||  Imlygic (talimogene laherparepvec) / Amgen
Trial completion, Metastases:  Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). (clinicaltrials.gov) -  Mar 26, 2024
P2, N=72, Completed,  Sponsor: Amgen
In this review, we describe applications for talimogene laherparepvec, a US Food and Drug Administration-approved intratumoral therapy in melanoma, as well as several classes of intratumoral therapies in development including novel oncolytic viruses, mRNA-based intratumoral injections, and cytokines and other signaling molecules. Active, not recruiting --> Completed

|||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Metastases: Clinical and Histological Response to Talimogene Laherparepvec Therapy in Advanced Melanoma: Impact on Overall Survival. (Pubmed Central) - Mar 18, 2024
Patients achieving cCR with pCR after T-VEC therapy have the most favorable overall survival outcomes, whereas those achieving cCR without pCR have inferior survival and those achieving less than cCR have the poorest overall survival outcomes. These findings emphasize the importance of histological confirmation and provide insights for optimizing T-VEC therapy in patients with advanced melanoma.



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