- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal: Brief overview: cemiplimab for the treatment of advanced basal cell carcinoma: PD-1 strikes again. (Pubmed Central) - Jan 28, 2022
The recent approval of cemiplimab for patients with advanced BCC who are resistant to or are intolerant of hedgehog inhibitor therapy fills a significant unmet need as these patients now have a viable, second-line systemic therapeutic option. This article summarizes the rationale and data leading to the approval for cemiplimab in advanced BCC.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
ADVERSE CARDIOVASCULAR EVENTS WITH IMMUNE CHECKPOINT INHIBITORS AND ASSOCIATIONS WITH PATIENT OUTCOMES (eAbstract site) - Jan 28, 2022 - Abstract #ACC2022ACC_5419;
A total of 6,976,139 patients were evaluated for their use of ICIs (Pembrolizumab, Nivolumab, Cemiplimab, Atezolizumab, Avelumab, Durvalumab, and Ipilimumab). Therapies utilizing either two ICI drugs or no ICI drugs revealed higher associations with poor outcomes in patients with cardiovascular events, compared with treatment strategies that utilized an ICI paired with another class of chemotherapeutic drug.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
A FATAL CASE OF CARDIAC METASTASIS OF SQUAMOUS CELL CANCER OF THE SKIN (Poster Hall_Hall C) - Jan 28, 2022 - Abstract #ACC2022ACC_4467;
We present a case of CM of a unique primary malignancy that manifested as subacute symptoms of heart failure. Although often clinically silent and rather rare, CM should always be considered in any individual with new or worsening cardiac symptoms and any known malignancy.
- |||||||||| Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, PD(L)-1 Biomarker, IO biomarker: The Multidisciplinary Management of Cutaneous Squamous Cell Carcinoma: A Comprehensive Review and Clinical Recommendations by a Panel of Experts. (Pubmed Central) - Jan 26, 2022
Thanks to such strong pre-clinical rationale, clinical trials led to the approval of anti-PD-1 cemiplimab by the FDA (Food and Drug Administration) and EMA (European Medicines Agency), and anti-PD-1 pembrolizumab by the FDA only. Here, we provide a literature review and clinical recommendations by a panel of experts regarding the diagnosis, treatment, and follow-up of CSCC.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Immunotherapy for Cutaneous Squamous Cell Carcinoma: Results and Perspectives. (Pubmed Central) - Jan 26, 2022
However, some cSCCs treated with immunotherapy develop either early or late resistance, so new drugs and new combinations are in a clinical study to overcome the mechanism underpinning these resistances. The present review focuses on the progress with immunotherapy to date and on new therapeutic strategies for cSCC.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial initiation date, Trial primary completion date: Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov) - Jan 24, 2022
P2, N=44, Not yet recruiting,
The present review focuses on the progress with immunotherapy to date and on new therapeutic strategies for cSCC. Trial completion date: Jan 2025 --> Apr 2025 | Initiation date: Jan 2022 --> Apr 2022 | Trial primary completion date: Jan 2025 --> Apr 2025
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Jan 20, 2022
The use of combination treatments, including the association of different immune checkpoint inhibitors, could be a strategy to increase treatment response, reducing the possibility of therapeutic failure. Also, different schemes of treatment or dose adjustments should be considered in order to reduce toxicity, avoiding treatment discontinuation and increasing patient´s quality of life.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Clinical, Journal, Checkpoint inhibition: Immune Checkpoint Inhibition in Marjolin Ulcer: A Case Series. (Pubmed Central) - Jan 18, 2022
Furthermore, 60% overall survival (3 patients) was observed in this limited cohort at 12 months after initiating anti-PD-1 therapy for MU. We describe the clinicopathologic features and clinical outcomes of our MU-SCC cohort.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, SAR439459 / Sanofi
Enrollment closed, Enrollment change, IO biomarker, Metastases: SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov) - Jan 17, 2022
P1b, N=3, Active, not recruiting,
It is hoped that these proposed absolute and relative criteria will help guide rational identification of patients who will receive maximum benefit from immunotherapy, while more clinical data accumulate. Recruiting --> Active, not recruiting | N=40 --> 3
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Immunotherapy (Cemiplimab)-Induced Bullous Pemphigoid: A Possible Pitfall in 18F-FDG PET/CT. (Pubmed Central) - Jan 13, 2022
A broad spectrum of inflammatory adverse events can occur in patients treated with immune checkpoint inhibitors, and FDG avidity of these lesions may mimic metastases. Knowledge of such imaging pitfalls is essential for interpreting 18F-FDG-PET/CT, particularly if they occur in the same organ as the primary tumor.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: EMPOWER-CSCC-1 : Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - Jan 13, 2022
P2, N=432, Active, not recruiting,
Knowledge of such imaging pitfalls is essential for interpreting 18F-FDG-PET/CT, particularly if they occur in the same organ as the primary tumor. Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2023 | Trial primary completion date: Oct 2025 --> Oct 2023
- |||||||||| Trial completion date, Trial primary completion date, Metastases: Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - Jan 12, 2022
P3, N=578, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2023 | Trial primary completion date: Oct 2025 --> Oct 2023 Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Clinical, Journal, HEOR, PD(L)-1 Biomarker, IO biomarker: First-Line ICI Monotherapies for Advanced Non-small-cell Lung Cancer Patients With PD-L1 of at Least 50%: A Cost-Effectiveness Analysis. (Pubmed Central) - Jan 8, 2022
For advanced NSCLC patients with PD-L1 of at least 50%, cemiplimab was a cost-effective option compared with pembrolizumab and a dominant alternative against atezolizumab. Our scenario analysis results supported the cemiplimab plus chemotherapy as a second-line therapy and suggested an extended QALY but overwhelming cost linking to pembrolizumab plus chemotherapy.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Distribution of immune-related adverse events (irAEs) across genitourinary (GU) malignancies. (In-Person & On Demand | Level 1, West Hall - E2) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_535;
In this dataset, there were differences in type and incidence of irAEs in patients with UC and RCC, while the sample size was too small to draw conclusions about patients with prostate and penile cancer. Further investigation is needed involving other solid tumor types, including non-GU malignancies, to definitively answer this question.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Checkpoint inhibition: Immune Checkpoint Inhibitor-Related Pulmonary Toxicity: A Comprehensive Review, Part II. (Pubmed Central) - Dec 23, 2021
Ipilimumab targets cytotoxic T lymphocyte-associated antigen-4...These checkpoint inhibitors are typically well tolerated; however, they may cause immune-mediated adverse effects, resulting in inflammation of any organ system. Pulmonary toxicity is vital to recognize, and it can be more challenging to diagnose in patients with lung cancer, given the nature of the disease course and treatment.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Review, Checkpoint inhibition: Efficacy of Immune Checkpoint Inhibitors in Rare Tumours: A Systematic Review. (Pubmed Central) - Dec 23, 2021
Treatment of advanced-stage rare tumours with ICI therapy was found to be associated with significant activity in some orphan diseases (e.g., Merkel cell carcinoma) and hepatocellular carcinoma. Several ongoing prospective clinical trials will expand the knowledge on the safety and efficacy of ICI therapy in patients with these rare cancers.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal, Real-world evidence: Cemiplimab-rwlc in Advanced Cutaneous Squamous Cell Carcinoma: a real-life experience in a French Dermatology Department. (Pubmed Central) - Dec 16, 2021
Cemiplimab-rwlc (CEMI), a programmed cell death protein 1 (PD-1) inhibitor, has demonstrated its efficacy for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) patients that has never been reported with chemotherapy and is currently recommended for the first-line treatment of patients with advanced CSCC by the European guidelines . However, real-life data and long-term survival data are lacking.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal: Cemiplimab- and nivolumab-induced myasthenia gravis: two clinical cases. (Pubmed Central) - Dec 16, 2021
It is important to identify and manage it promptly. We present two cases of immune-related de novo myasthenia gravis observed at the Modena Cancer Center in two elderly patients treated with two anti-PD-1 monoclonal antibodies: cemiplimab and nivolumab.
- |||||||||| cavrotolimod (AST-008) / Exicure
Enrollment closed, Enrollment change, IO biomarker, Metastases: Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors (clinicaltrials.gov) - Dec 16, 2021
P1b/2, N=57, Active, not recruiting,
We present two cases of immune-related de novo myasthenia gravis observed at the Modena Cancer Center in two elderly patients treated with two anti-PD-1 monoclonal antibodies: cemiplimab and nivolumab. Recruiting --> Active, not recruiting | N=130 --> 57
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal: Management of partial and non-responding cutaneous squamous cell carcinoma. (Pubmed Central) - Dec 16, 2021
For patients with locally advanced and metastatic cSCC, the programmed cell death 1 (PD-1) inhibitor cemiplimab is approved for systemic treatment...In addition to the previously established local treatment with radiotherapy or systemic treatment with chemotherapy and epidermal growth factor receptor inhibitors, ongoing trials are currently focussed on re-stimulating the antitumour immune response in patients with advanced cSCC refractory to PD-1 inhibitors. In this review, ongoing and recently finished trials with different therapeutic approaches will be discussed.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Treatment approaches of advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Dec 16, 2021
In addition, real-world studies are needed to validate the results observed in clinical trials and numerous clinical trials in the neoadjuvant or adjuvant setting are ongoing. Finally, further studies should investigate predictive biomarkers useful to better select patients to maximize the treatment efficacy.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Tissue Age Affects the Proportion Score in the 22c3 Immunohistochemistry Companion Diagnostic Test (Poster Board Number: 129; LACC West Exhibit Hall A) - Dec 13, 2021 - Abstract #USCAP2022USCAP_1715;
We can reproduce this signal loss by experimental degradation of glycosyl residues in FFPE tissue. This data suggests that when older tissues are used in the 22c3 companion diagnostic test, there may be significantly reduced positive staining.
- |||||||||| SAR439459 / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Nov 30, 2021
P1, N=161, Active, not recruiting,
No abstract available Trial completion date: May 2023 --> Jan 2022 | Trial primary completion date: Apr 2023 --> Dec 2021
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: The Role of Systemic Therapy in Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Nov 29, 2021
Adjuvant postoperative chemoradiation with platinum has been called into question based on recent data. Programmed cell death protein 1 receptor immune checkpoint inhibitors have demonstrated profound activity in HNCSCC, and cemiplimab and pembrolizumab now are approved for use for unresectable/metastatic disease.
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