Safety and preliminary efficacy of talimogene laherparepvec (T-VEC) in combination (combo) with pembrobrolizumab (Pembro) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC): A multicenter, phase 1b study (MASTERKEY-232).

Harrington, Kevin; Kong, Anthony; Mach, Nicolas; Rordorf, Tamara; Jaime, Jesús Corral; Espeli, Vittoria; Treichel, Sheryl; Gümüşçü, Burak; Kim, Jaeyeon; Chesney, Jason

doi:10.1200/jco.2018.36.15_suppl.6036

Cited by 23 publications

(13 citation statements)

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“…IO-IO: Checkpoint + innate immune activationMASTERKEY-232 (NCT02626000)Phase 1b/3. Combination pembrolizumab + talimogene laherparepvec (T-VEC) as second-line therapy in R/M HNSCC patients.T-VEC is the first FDA-approved oncolytic immunotherapy which works to systemically enhance the antitumor immune response [132] [133]. Twenty-four (66.7%) patients experienced a grade 3 or higher TRAE, with 5 related to T-VEC and 3 related to Pembrolizumab.…”

Section: Key Clinical Questionsmentioning

confidence: 99%

See 1 more Smart Citation

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

Cohen¹,

Bell²,

Bifulco³

et al. 2019

j. immunotherapy cancer

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522

422

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Head and neck cancers, including those of the lip and oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx and nasopharynx represent nearly 700,000 new cases and 380,000 deaths worldwide per annum, and account for over 10,000 annual deaths in the United States alone. Improvement in outcomes are needed for patients with recurrent and or metastatic squamous cell carcinoma of the head and neck (HNSCC). In 2016, the US Food and Drug Administration (FDA) granted the first immunotherapeutic approvals – the anti-PD-1 immune checkpoint inhibitors nivolumab and pembrolizumab – for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (HNSCC) that is refractory to platinum-based regimens. The European Commission followed in 2017 with approval of nivolumab for treatment of the same patient population, and shortly thereafter with approval of pembrolizumab monotherapy for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score and have progressed on or after platinum-containing chemotherapy. Then in 2019, the FDA granted approval for PD-1 inhibition as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC, approving pembrolizumab in combination with platinum and fluorouracil for all patients with HNSCC and pembrolizumab as a single agent for patients with HNSCC whose tumors express a PD-L1 combined positive score ≥ 1. These approvals marked the first new therapies for these patients since 2006, as well as the first immunotherapeutic approvals in this disease. In light of the introduction of these novel therapies for the treatment of patients with head and neck cancer, The Society for Immunotherapy of Cancer (SITC) formed an expert committee tasked with generating consensus recommendations for emerging immunotherapies, including appropriate patient selection, therapy sequence, response monitoring, adverse event management, and biomarker testing. These consensus guidelines serve as a foundation to assist clinicians’ understanding of the role of immunotherapies in this disease setting, and to standardize utilization across the field for patient benefit. Due to country-specific variances in approvals, availability and regulations regarding the discussed agents, this panel focused solely on FDA-approved drugs for the treatment of patients in the U.S. Electronic supplementary material The online version of this article (10.1186/s40425-019-0662-5) contains supplementary material, which is available to authorized users.

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Section: Key Clinical Questionsmentioning

confidence: 99%

“…24/36 (66.7%) pts. had grade 3 or higher treatment-emergent adverse events [133]. KEYNOTE-184 (NCT02521870)Phase 1b/2.…”

Section: Key Clinical Questionsmentioning

confidence: 99%

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

Cohen¹,

Bell²,

Bifulco³

et al. 2019

j. immunotherapy cancer

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522

422

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“…Immunotherapies that further engage both innate and adaptive immunity are also in development (Figure 3). In combination with pembrolizumab, intratumoral injections of oncolytic viruses (talimogene laherparepvec, T-VEC) [139] or Toll-like receptor 9 agonist CpG-ODN [140] have shown promising results and manageable toxicity profiles. Ongoing Phase I/II trials of adoptive T cell therapy, where patients are treated with autologous T cells, have generated responses in some patients.…”

Section: Emerging Developments-immunotherapymentioning

confidence: 99%

The Evolution of Care of Cancers of the Head and Neck Region: State of the Science in 2020

Yan

Knochelmann

Morgan

et al. 2020

Cancers

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Cancers that arise in the head and neck region are comprised of a heterogeneous group of malignancies that include carcinogen- and human papillomavirus (HPV)-driven mucosal squamous cell carcinoma as well as skin cancers such as cutaneous squamous cell carcinoma, basal cell carcinoma, melanoma, and Merkel cell carcinoma. These malignancies develop in critical areas for eating, talking, and breathing and are associated with substantial morbidity and mortality despite advances in treatment. Understanding of advances in the management of these various cancers is important for all multidisciplinary providers who care for patients across the cancer care continuum. Additionally, the recent Coronavirus Disease 2019 (COVID-19) pandemic has necessitated adaptations to head and neck cancer care to accommodate the mitigation of COVID-19 risk and ensure timely treatment. This review explores advances in diagnostic criteria, prognostic factors, and management for subsites including head and neck squamous cell carcinoma and the various forms of skin cancer (basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, and melanoma). Then, this review summarizes emerging developments in immunotherapy, radiation therapy, cancer survivorship, and the delivery of care during the COVID-19 era.

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“…This trial showed a manageable safety profile, with however 24/36 (66.7%) patients experiencing serious adverse events, including one vaccine-related death. The overall response rate was 16.7%, the majority of which was in patients with PD-L1-positive tumours, and the DCR was 38.9% (again mostly in PD-L1-positive tumours) [160].…”

Section: Oncolytic Virus Vaccinesmentioning

confidence: 90%

Cancer Vaccines

Henriquez¹,

Arkenau²,

Dutoit³

et al. 2019

Cancer Immunotherapy and Biological Cancer Treatments

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Recent advances in immuno-oncology have allowed for the design of more specific and efficient cancer vaccine approaches. There has been an improvement in molecular biology techniques, as well as a greater understanding of the mechanisms involved in the activation and regulation of T cells and the interplay between the components of the immune system and the escape mechanisms used by cancer cells and the tumour microenvironment. As a result, many interesting developments in therapeutic cancer vaccines are ongoing, with influence on survival still to be proven. The spectrum of tumour antigens that are recognised by T cells is still largely unchartered and, most importantly, dynamically evolving over time, driven by clonal evolution and treatment-driven selection. Vaccine approaches currently in development and tested in clinical studies are based on tumour antigens specifically identified for each tumour type, on tumour cells or dendritic cells, the latter having the potential to be modified to incorporate immunostimulatory genes. However, interplay between the immune system and the tumour and the inhibitory mechanisms developed by tumour cells to subvert immune responses are crucial issues that will need to be targeted in order for efficient therapeutic vaccines to emerge.

show abstract

Safety and preliminary efficacy of talimogene laherparepvec (T-VEC) in combination (combo) with pembrobrolizumab (Pembro) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC): A multicenter, phase 1b study (MASTERKEY-232).

Cited by 23 publications

References 0 publications

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

The Evolution of Care of Cancers of the Head and Neck Region: State of the Science in 2020

Cancer Vaccines

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