Libtayo (cemiplimab-rwlc) / Regeneron, Medison, GENESIS Pharma - LARVOL DELTA

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer (clinicaltrials.gov) - P2 | N=44 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Aug 2026

Enrollment open • IO biomarker • Trial initiation date • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Hematologic adverse events associated with immune checkpoint inhibitors: A real-world pharmacovigilance analysis using the faers database (ASH 2025) - "We employed 8 ICIs (including the brand and generic names)—atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab in the analysis. This large, real-world pharmacovigilance study provides comprehensive insight into hematologic adverse events associated with ICIs. Immune thrombocytopenia was the most prominent signal across agents, with additional drug-specific patterns observed. These findings underscore the need for focused monitoring strategies and may inform clinical decision-making and future prospective safety evaluations."

Adverse events • Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Febrile Neutropenia • Hematological Malignancies • Immune Thrombocytopenic Purpura • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • ROR1

Progress in immunotherapy for resectable head and neck squamous cell carcinoma. (PubMed, Med Oncol) - "This report conducts a systematic review of four principal studies: ① The KEYNOTE-689 trial was the inaugural study to establish that "pembrolizumab combined with standard therapy" diminishes the risk of disease progression or mortality by 34% in patients with Programmed Cell Death-L1(PD-L1) CPS ≥ 10, resulting in Food and Drug Administration (FDA) approval; ② The NIVOPOSTOP trial revealed that adjuvant nivolumab alongside CRT significantly improved 3-year disease-free survival (DFS) (63.1% vs. 52.5%), with efficacy unaffected by PD-L1 status; ③ The C-POST trial indicated a substantial DFS advantage with adjuvant cemiplimab in high-risk skin squamous cell carcinoma (HR = 0.32);④ The NeoRTPC02 trial innovatively integrated low-dose radiotherapy with immune chemotherapy, achieving a pathological complete response(pCR) rate of 60.9%. Nonetheless, the ideal treatment approach, strategies for reducing radiation dosage, preservation of organ function, and selection..."

IO biomarker • Journal • Review • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • PD-L1

Cost-effectiveness of second- or third-line treatment with tisotumab vedotin for metastatic or recurrent cervical cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "To evaluate the cost-effectiveness of tisotumab vedotin (TV) versus single-agent chemotherapy in patients with recurrent or metastatic cervical cancer (r/mCC) after failure of first-line treatment, from the perspective of the Spanish National Health System. TV offers a modest benefit over chemotherapy in patients with r/mCC and reaches or surpasses the upper bounds of ICER applied in Spain when priced comparably to cemiplimab. However, the magnitude of clinical benefit is uncertain."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

BI18 Skin conditions in immunocompromised individuals: a service evaluation. (PubMed, Br J Dermatol) - "Tacrolimus, mycophenolate mofetil and prednisolone accounted for 76% of all immunosuppressive medications prescribed...For patients at high risk of further keratinocyte carcinomas, only 42% were receiving chemoprevention with acitretin or nicotinamide. There were 45 recurrences of squamous cell carcinoma (SCC) and basal cell carcinoma, and seven patients required treatment for metastatic SCC or sarcomatoid carcinoma - these were managed with cemiplimab, radiotherapy and surgical excision...Severe inflammatory conditions and a range of undiagnosed cutaneous lesions add to the complex dermatological burden in this population. Multidisciplinary collaboration between dermatology, transplant and haematology teams remains crucial to optimizing outcomes for these patients."

Journal • Retrospective data • Atopic Dermatitis • Basal Cell Carcinoma • Dermatitis • Dermatology • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Melanoma • Non-melanoma Skin Cancer • Oncology • Rheumatology • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Transplantation

BI03 Erythrodermic psoriasis following second cycle of cemiplimab: a case report. (PubMed, Br J Dermatol) - "The patient was admitted and commenced on intravenous methylprednisolone, leading to symptom resolution within 7 days. Understanding the pathophysiological mechanisms underlying these toxicities is essential for optimizing treatment strategies, minimizing adverse effects without compromising ICI efficacy, and ultimately prolonging patient access to immunotherapy. Further research into immune-related dermatological conditions may also provide valuable insights into the molecular mechanisms governing endogenous dermatological diseases, offering new avenues for targeted dermatological therapies."

IO biomarker • Journal • Alopecia • Dermatology • Dermatopathology • Immunology • Oncology • Psoriasis • Squamous Cell Carcinoma • Vitiligo • IL17A • IL23A

P060 A retrospective analysis of squamous cell carcinomas in adult epidermolysis bullosa: insights from a tertiary referral centre. (PubMed, Br J Dermatol) - "Treatment modalities included wide local excision (WLE) (76%), amputation (11%), WLE with subsequent amputation (5%) and cemiplimab therapy (8%)...Due to the rarity of EB, and the high occurrence of SCC, an MDT approach is essential in their management with efforts to optimize early detection, enhanced surveillance and standardized management pathways that can reduce morbidity and mortality in this high-risk population. Addressing psychosocial aspects of care remains a critical priority, particularly for cases of metastatic SCC."

Journal • Retrospective data • Genetic Disorders • Oncology • Palliative care • Skin Cancer • Squamous Cell Carcinoma

BI05 Cemiplimab toes: a new entity in the expanding spectrum of immune checkpoint inhibitor skin toxicities. (PubMed, Br J Dermatol) - "As pain was severe, the initial concern was of a vasculitic process and oncology started prednisolone 2 mg kg-1 per day (120 mg per day) and flucloxacillin, with symptoms improving rapidly...Although she responded well to oral steroids and suspending cemiplimab, her skin flared with subsequent cycles with prednisolone doses below 10 mg per day despite topical treatment with clobetasol propionate, tacrolimus and calcipotriol-betamethasone ointments, fludroxycortide tape, Fucibet cream and potassium permanganate soaks...Clinically some features were reminiscent of 'COVID toes', but the underlying mechanism is unknown. This case of 'cemiplimab toes' is a striking reminder of the ever-evolving spectrum of cutaneous irAEs associated with immunotherapy and the challenges in diagnosing and managing these effectively to mitigate morbidity while continuing oncological treatment."

Checkpoint inhibition • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Hematological Disorders • Immunology • Myositis • Non-melanoma Skin Cancer • Novel Coronavirus Disease • Oncology • Pain • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Vasculitis

BI04 Bullous pemphigoid induced by cemiplimab to treat metastatic squamous cell carcinoma in a renal transplant patient. (PubMed, Br J Dermatol) - "He was treated with clobetasol 0.05% ointment, doxycycline 100 mg twice daily, nicotinamide 500 mg three times daily and prednisolone 30 mg daily (equivalent to 0.3 mg kg-1 per day). The severity of disease and treatments used were variable, and in some, cemiplimab was recommenced. Management of more severe bullous pemphigoid with oral immunosuppression requires careful consideration of the underlying malignancy and additionally, in our patient's case, chronic renal impairment following renal transplantation."

Journal • Bullous Pemphigoid • Chronic Kidney Disease • Dermatology • Dermatopathology • Immunology • Nephrology • Non-melanoma Skin Cancer • Oncology • Renal Disease • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - P3 | N=161 | Completed | Sponsor: Dan Zandberg | Recruiting ➔ Completed | N=578 ➔ 161 | Trial completion date: Nov 2031 ➔ Nov 2025 | Trial primary completion date: Nov 2030 ➔ Oct 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Anal Carcinoma • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Efficacy and safety of S-1 for locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma: A retrospective, multicenter study (ESMO Asia 2025) - "In phase II non-randomized trials, cemiplimab and pembrolizumab in locally advanced (LA) cSCC demonstrated an objective response rate (ORR) of 47–50%, 12-month progression-free survival (PFS) of 54–58%, and 12-month overall survival (OS) of 73–93%. S-1 demonstrated comparable efficacy to ICIs in both LA and R/M cSCC, with a notably lower incidence of severe AEs, supporting its potential role as a tolerable, effective systemic treatment option in this setting."

Metastases • Retrospective data • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

NSABP FC-13 (EMPIRE): A phase II platform study of cemiplimab monotherapy or cemiplimab-based combinations in patients with colorectal cancer and minimal residual disease (MRD) after definitive therapy. (ASCO-GI 2026) - P2 | "Funded by Regeneron, Natera, Inc., NSABP Foundation, Inc. Clinical Trial Registration Number: NCT07058012 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Minimal residual disease • Monotherapy • P2 data • Residual disease • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Pre-ispy trial: a phase i/ib oncology platform program (pre-i-spy-p1) nct05868226 (SABCS 2025) - P1 | "The current arms under study are PRE1 ALX-148/T-DXd; PRE2 tucatinib/zanidatamab; and PRE3 vidutolimod/cemiplimab. Conclusion The PRE-ISPY phase I/Ib trial has been successfully implemented nationally as part of the Consortium of I-SPY trials. Once safety is established, promising regimens can be rapidly transitioned to I-SPY2.2, K-SPY or other phase II/III trials."

P1 data • Breast Cancer

From Survival to Side Effects: Retrospective Analysis of Adverse Events in Checkpoint Inhibitor Therapy for Melanoma Using the FAERS Database (EADV 2025) - "Reports were included if the indication was malignant or metastatic melanoma and the treatment involved checkpoint inhibitors (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Avelumab, Durvalumab, Ipilimumab, Tremelimumab, or Relatlimab). This study provides the most comprehensive FAERS-based analysis to date of checkpoint inhibitor- associated adverse events in melanoma treatment. While PD-1 inhibitors dominate current usage, significant differences in AE profiles, fatality rates, and geographic patterns exist across drug classes. These findings can guide clinicians in personalized risk assessment and AE monitoring strategies for patients undergoing immunotherapy."

Adverse events • Checkpoint inhibition • Retrospective data • Cardiovascular • Melanoma • Oncology • Solid Tumor • LAG3

Adverse Events of Immune Checkpoint Inhibitors in Cancer Patients with Comorbid Diabetes: A Real-World Pharmacovigilance Analysis of the FDA Adverse Event Reporting System Database (2011-2025). (PubMed, Cancer Control) - "Reports listing anti-PD-1 (Nivolumab, Pembrolizumab, Cemiplimab), anti-PD-L1 (Atezolizumab, Avelumab, Durvalumab), and anti-CTLA-4 (Ipilimumab, Tremelimumab) agents as suspected drugs were extracted. Fatal subgroup occurred sooner than non-fatal subgroup (median 106.7 vs 132.5 days; P = 0.004).ConclusionDiabetic cancer patients experienced the full spectrum of ICI-associated toxicities, with combination treatments linked to greater lethality. Multidisciplinary surveillance during the first 3-4 months of therapy, glycemic control, and long-term follow-up may be essential to optimize benefit and minimize harm in this expanding population."

Adverse events • Checkpoint inhibition • Journal • Real-world evidence • Retrospective data • Diabetes • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Interstitial Lung Disease • Metabolic Disorders • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Real-World Evidence Study on PD-L1 Testing and Use of Immuno-Oncology (IO) Treatments Among Cancer Patients in the Helsinki and Uusimaa (HUS) Region, Finland (ISPOR-EU 2025) - "The IO-treatments included nivolumab, pembrolizumab, durvalumab, avelumab, atezolizumab, cemiplimab, dostarlimab, ipilimumab and tremelimumab. PD-L1 testing was most frequently done in patients with melanoma, colorectal, lung, breast, kidney and bladder cancer. In this study, which is part of the Collaboration Research (CORE) dataset of Medaffcon, we show the frequency of PD-L1 testing and use of IO-treatments in HUS region, Finland. Both PD-L1 testing and use of IO-treatments were most common among lung cancer patients. We also show a notable increase in both PD-L1 testing and use of IO-treatments over time."

Clinical • HEOR • Immuno-oncology • IO biomarker • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Pneumonitis but not other immune related adverse events (irAEs) associate with pre-treatment immune signatures in early-stage breast cancer patients receiving neoadjuvant immunotherapy (IO): results from 5 IO arms in I-SPY2 (SABCS 2025) - "Methods 356 patients (206 HR+HER2- and 150 TN) across 5 IO arms (69 pembrolizumab (Pembro), 76 Pembro/SD101, 73 durvalumab/olaparib, 62 cemiplimab (Cemi), and 78 Cemi/LAG3) with irAE and pCR data were analyzed. This association was observed exclusively in patients with ImPrint+ tumors, where PD1 mRNA levels predicted pneumonitis. mRNA signatures may help enable early identification and treatment of IO patients likely to develop pneumonitis."

Adverse events • Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • LAG3 • PD-1 • PD-L1

Immune checkpoint inhibitors and hemophagocytic lymphohistiocytosis: Disproportionality analysis from FAERS (ESMO-IO 2025) - "Cases were grouped by PD-1 inhibitors (pembrolizumab, nivolumab, cemiplimab, sintilimab, tislelizumab, camrelizumab, retifanlimab, toripalimab) and PD-L1 inhibitors (atezolizumab, durvalumab, avelumab). Clinicians should remain vigilant for HLH—especially early fever, cytopenias, and rising ferritin—and seek prompt hematology input with diagnostic workup, which may be lifesaving. Differences may reflect pharmacodynamics, indication mix, combinations, and reporting bias; prospective, mechanism-focused studies are needed to clarify causality and guide mitigation strategies.Legal entity responsible for the study The authors."

Checkpoint inhibition • Breast Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "Compared with chemotherapy, except for ipilimumab+chemo [HR = 0.92,95%CI: (0.59-1.40)], atezolizumab+chemo [HR = 0.88, 95%CI: (0.56-1.40)], and durvalumab+chemo [HR = 0.84, 95% CI: (0.52-1.40)], durvalumab+ tremelimumab+chemo [HR = 0...Cemiplimab [HR = 0.48, 95% CI: (0.34-0.67)] showed the best OS benefit...Sugemalimab+chemo provided the best survival benefit [HR = 0.34, 95% CI: (0.24-0.48)]. For PD-L1≥50% tumors, penpulimab showed excellent OS and PFS; for PD-L1 1-49% tumors, pembrolizumab+chemo and camrelizumab+chemo achieved the best OS and PFS, respectively; for PD-L1≥1% tumors, the tislelizumab+chemo and camrelizumab+chemo showed the best OS and PFS results, while for tumors with PD-L1 <1%, both nivolumab and serplulimab+chemo provided significant survival benefit...Ipilimumab+chemo had the highest incidence of adverse events (AEs) [OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Magnesium Is Associated with Favorable Outcomes of Cancer Patients Treated with Immune Checkpoint Inhibitors (ASH 2024) - "Included in the study were patients who received various ICIs treatments, such as IBI318, pembrolizumab, nivolumab, atezolizumab, durvalumab, cemiplimab, tislelizumab, toripalimab, and sintilimab, with monitoring of their serum magnesium ion levels. These findings underscore the predictive value of serum magnesium levels in evaluating clinical outcomes among patients receiving ICIs therapy.Conclusion : This multicenter study demonstrates that patients receiving ICIs exhibit significantly improved outcomes among those with elevated serum magnesium levels compared to those with low levels. Further prospective validation studies are essential to evaluate magnesium levels in ICI-treated patients and to supplement magnesium preparations in patients with magnesium deficiency to confirm these findings."

Checkpoint inhibition • Clinical • Esophageal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Oncology • Solid Tumor • CD8

Kidney Outcomes Associated with Immune Checkpoint Inhibitor Therapy in Patients with Cancer: A Global Cohort Analysis Using TriNetX (KIDNEY WEEK 2025) - "Cohort A (n=38,530) included patients treated with an FDA-approved ICI (atezolizumab, durvalumab, nivolumab, pembrolizumab, ipilimumab, avelumab, cemiplimab). While ESRD was less common in the ICI group, the higher incidence of acute and immune-mediated renal syndromes warrants careful monitoring of kidney function in patients undergoing ICI therapy. Prospective studies are needed to clarify causality and identify modifiable risk factors."

Checkpoint inhibition • Clinical • Acute Kidney Injury • Chronic Kidney Disease • Glomerulonephritis • Nephrology • Oncology • Renal Disease

HYPERBOLIC: Hyperprogression in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial (clinicaltrials.gov) - P2 | N=74 | Not yet recruiting | Sponsor: Università Vita-Salute San Raffaele

Biomarker • IO biomarker • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Neoadjuvant Immunotherapy in the Management of Cutaneous Squamous Cell Carcinoma. (PubMed, Skin Therapy Lett) - "This paper reviews data showing the safety and efficacy of cemiplimab as neoadjuvant treatment in cutaneous squamous cell carcinoma. Early findings suggest that neoadjuvant immunotherapy may help improve surgical outcomes by reducing tumor burden before resection."

Journal • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Impact of Circadian Rhythm on Immunotherapy (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: Liza Villaruz, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacovigilance study of the frequency of gastrointestinal ulceration reports associated with immune checkpoint inhibitors: insights from the FDA adverse event reporting system. (PubMed, Front Pharmacol) - "A significant association was observed between the drugs Ipilimumab (ROR: 3.73 [3.14-4.44], IC: 1.89), Pembrolizumab (ROR: 3.08 [2.83-3.35], IC: 1.60), Atezolizumab (ROR: 4.10 [3.67-4.58], IC: 2.02), Nivolumab (ROR: 2.45 [2.23-2.69], IC: 1.28) and reports of GU. Conversely, Cemiplimab (ROR: 1.06 [0.55-2.05], IC: 0.09) did not exhibit a significant correlation...This study presents the most current real-world evidence regarding the safety profile of ICIs therapy in relation to GU, highlighting variations among different ICIs and between genders. It is imperative for healthcare providers to maintain heightened awareness of potential GU adverse events associated with ICIs and to implement timely preventive or therapeutic interventions to enhance the safety of ICIs in clinical practice."

Adverse events • Checkpoint inhibition • Journal • Gastrointestinal Disorder • Oncology