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

Confidence in patient-provider consideration of immunotherapy in a congested landscape. (ASCOQLTY 2025) - "Increased understanding of subgroup specific outcomes/benefits of frontline immunotherapy (cemiplimab + chemotherapy in patients with squamous NSCLC)... The outcomes data reflected a lack of awareness of the importance of testing and reveal an opportunity to better incorporate PD-L1 status in patient discussions regarding its relevance for appropriate treatment selection. These data suggest the role of education in empowering clinicians and patients with a deeper knowledge of appropriate application of immunotherapy and the importance of reporting adverse events in a timely manner."

Clinical • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Secondary primary lymphoma (SPL) following immune checkpoint inhibitor (ICI) therapy: FDA Adverse Event Reporting System (FAERS) review. (ASCOQLTY 2025) - " We searched the FAERS database for reports submitted through March 31, 2025, involving nivolumab, pembrolizumab, ipilimumab, atezolizumab, durvalumab, cemiplimab, avelumab, dostarlimab, and relatlimab/nivolumab. This analysis identified SPL cases following ICI therapy including aggressive T-cell and B-cell lymphomas warranting further pharmacovigilance study as well as investigation of immune-mediated mechanisms of lymphomagenesis following ICI exposure."

Adverse events • Checkpoint inhibition • Review • Adult T-Cell Leukemia-Lymphoma • B Cell Lymphoma • Burkitt Lymphoma • CNS Lymphoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • Solid Tumor • Splenic Marginal Zone Lymphoma • T Cell Non-Hodgkin Lymphoma • Waldenstrom Macroglobulinemia • LAG3 • PD-1

Association between patient-reported outcomes (PROs) and overall survival (OS) in aNSCLC patients treated with first-line (1L) cemiplimab-based therapy (ESMO 2025) - No abstract available

Clinical • Patient reported outcomes • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase II trial combining pulsed sonidegib (soni) and cemiplimab (cemi) in advanced basal cell carcinoma (aBCC) (ESMO 2025) - No abstract available

Metastases • P2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

CemiplimAb-rwlc survivorship and epidemiology (CASE): A prospective, non-interventional study of the safety and effectiveness of cemiplimab in immunocompromised/immunosuppressed (IC/IS) patients with advanced cutaneous squamous cell carcinoma (CSCC) at 2 years' follow-up (ESMO 2025) - No abstract available

Clinical • Metastases • Observational data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Adjuvant cemiplimab for high-risk cutaneous squamous cell carcinoma: Evaluating dosing intervals in a phase III trial (ESMO 2025) - No abstract available

Clinical • P3 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Neoadjuvant plus adjuvant treatment with cemiplimab in surgically resectable, high risk stage III/IV (M0) cutaneous squamous cell carcinoma (NEO-CESQ): Biomarker analysis (ESMO 2025) - No abstract available

Biomarker • Clinical • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phase II study on the treatment of recurrent/metastatic (R/M) head and neck squamous cell cancer (HNSCC) using low-dose weekly carboplatin and paclitaxel metronomic chemotherapy (MCT) combined with cemiplimab (ESMO 2025) - No abstract available

Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Randomised phase II study of ubamatamab ± cemiplimab in patients (pts) with platinum-resistant ovarian cancer (OC) (ESMO 2025) - No abstract available

Clinical • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Quality of Life (QoL) and updated efficacy outcomes of first-line single-agent cemiplimab in advanced penile carcinoma: The EPIC-B UK multicenter study (ESMO 2025) - No abstract available

Clinical • HEOR • Metastases • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor

Primary results from a randomized phase II trial of BNT111 in combination with cemiplimab with calibrator monotherapy arms in anti-PD-(L)1 relapsed/refractory melanoma (ESMO 2025) - No abstract available

Clinical • Combination therapy • Monotherapy • P2 data • Melanoma • Oncology • Solid Tumor

Analysis of second primary cutaneous squamous cell carcinoma (CSCC) tumors (SPTs) reported during the C-POST trial, a randomized phase III study of adjuvant cemiplimab vs placebo (pbo) for high-risk CSCC (ESMO 2025) - No abstract available

Clinical • P3 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Results from a phase I expansion cohort of solnerstotug (pH-selective anti-VISTA antibody) combined with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy (ESMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Gastrointestial Outcomes in Patients With Concomitant Use of Immuno Checkpoint Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists: A Population-Based Cohort Study in the United States (ACG 2025) - "We included patients with who received GLP-1 RAs drugs (semaglutide, liraglutide, dulaglutide and tirzepatide) and ICIs drugs (ipilimumab, nivolumab, pembrolizumab, atezolizumab, atezolizumab, avelumab, durvalumab, relatlimab and cemiplimab) between January 1, 2010, and October 31, 2024... A total of 124,750 patients using ICIs were identified, 4,155 of these individuals were on GLP -1 RAs; 4,148 out of those 4,155 (mean [SD] age, 64.2 [11.4] years; 1,905 [45.9%] female) were matched with 4,148 individuals (mean [SD] age, 64.3[12.9] years; 1,884 [45.4%] female) who did not take GLP-1 RAs. GLP-1 RAs was associated with lower odds of all-cause mortality (OR, 0.37; 95% CI, 0.34-0.41), diarrhea (OR, 0.83; 95% CI, 0.77-0.96), colitis (OR, 0.75; 95% CI, 0.64-0.88), nausea and vomiting (OR, 0.83; 95% CI, 0.72-0.95), early satiety (OR, 0.52; 95% CI, 0.31-0.87), bloating (OR, 0.77; 95% CI, 0.62-0.95), and esophagitis (OR, 0.73; 95% CI, 0.54-0.97), when compared with non-GLP-1RAs..."

Checkpoint inhibition • Clinical • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hepatology • Immunology • Oncology • Pancreatitis

A Case Report (ACG 2025) - "While standard treatments include surgery, immunotherapies like Pembrolizumab and Cemiplimab are gaining prominence for advanced cases. The pathophysiology of ICI-induced celiac disease may involve the activation of previously silent celiac disease and hyperactivation of gut T-cells. This underscores the need for vigilant monitoring in patients undergoing treatment with ICIs.Figure: Table: Diagnostic Labs"

Case report • Clinical • Basal Cell Carcinoma • Celiac Disease • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Non-melanoma Skin Cancer • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Do age and performance status matter? A systematic review and network meta-analysis of immunotherapy studies in untreated advanced/metastatic non-oncogene addicted NSCLC. (PubMed, Front Immunol) - "In younger patients, ICI+CT combinations (e.g. pembrolizumab+CT, cemiplimab+CT, camrelizumab+CT) ranked highest for OS and PFS. This meta-analysis highlights how the efficacy of ICIs in advanced NSCLC varies by age and PS. These findings support a tailored approach to immunotherapy and emphasize the need for trials specifically targeting frail and elderly populations."

Clinical • Journal • Retrospective data • Review • Geriatric Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Immune Checkpoint Inhibitors and Venous Thromboembolism in Patients with Head and Neck Cancer Undergoing Surgery (AAO-HNSF 2025) - "The aim of this study is to evaluate VTE risk in a cohort of patients with HNC treated with surgery and ICIs. De-identified data from the TriNetX Global Collaborative Network database was used to identify adult surgical patients (≥18 years) using International Classification of Diseases 10th Revision and Common Procedural Terminology codes and were further refined by use of nivolumab, pembrolizumab, or cemiplimab within 1-year before or up to 3-months after surgery. This study highlights the importance of risk stratification and adequate risk reduction in the setting of increasing ICI use for patients with HNC undergoing surgery."

Checkpoint inhibition • Clinical • Surgery • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Venous Thromboembolism

Neoadjuvant Cemiplimab for Resectable Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: A Case Series (AAO-HNSF 2025) - "Neoadjuvant cemiplimab can induce a variable gross, imaging, and pathologic response depending on patient and tumors characteristics. The ongoing NRG-HN014 trial will determine whether neoadjuvant cemiplimab can improve survival."

Clinical • Metastases • Fatigue • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Association of Socioeconomic Factors and Immunotherapy Use in Head and Neck Cutaneous Squamous Cell Carcinoma (AAO-HNSF 2025) - "Outcomes studied include receipt of immunotherapy (pembrolizumab, nivolumab, ipilimumab, and cemiplimab). Receipt of immunotherapy in advanced cSCCHN is associated with a lower SVI, Northeast region, and non-smoking status. As immunotherapy use is established as standard of care treatment, targeted strategies to improve equity in immunotherapy usage and increase patient access may help reduce disparities. Future research should further elucidate barriers to access and impact on patient outcomes."

Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

GUT MICROBIOTA MODULATION AS A NOVEL THERAPEUTIC APPROACH FOR IMMUNE-CHECKPOINT INHIBITORS-RELATED DIARRHEA AND COLITIS (UEGW 2025) - "All patients were treated with ICI (Pembrolizumab: n=25 , Dostarlimab: n=4, Nivolumab: n=4; Atezolizumab: n=3; Novulumab and Ipilumab: n=2, Cemiplimab: n=2; Mogamulizumab: n=1; Pertuzumab: n=1)...Multi-strain probiotics were administered to 27 (64.3% ) patients, rifaximin to 22 (52,4%)... Therapeutic modulation of gut microbiota appears to be a promising safe and effective approach for treating ICI-related diarrhea and colitis. However, these preliminary findings need confirmation through more consolidated and well-designed studies."

Checkpoint inhibition • Gut Microbiota • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Oncology

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma (FDA) - "Efficacy was evaluated in C-POST (NCT03969004), a randomized, double-blind, multicenter, placebo-controlled trial in 415 patients with CSCC at high risk of recurrence after surgery and radiation....The recommended dose is 350 mg intravenously every three weeks for 12 weeks, followed by 700 mg every six weeks, or 350 mg every three weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks."

FDA approval • Squamous Cell Skin Cancer

A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jun 2029 ➔ May 2030 | Trial primary completion date: Jul 2028 ➔ May 2030

Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: Maastricht University Medical Center | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2

Global safety profile of PD-1/PD-L1 inhibitors in hepatic autoimmune disorders: A global disproportionality analysis. (PubMed, Medicine (Baltimore)) - "The analysis centered on PD-1/PD-L1 inhibitors, classified by Anatomical Therapeutic Chemical codes (e.g., atezolizumab, avelumab, budigalimab, cemiplimab, dostarlimab, durvalumab, nivolumab, pembrolizumab, sintilimab, spartalizumab, and tislelizumab). Most PD-1/PD-L1 inhibitors showed pharmacovigilance signals for hepatic autoimmune disorders, particularly nivolumab and pembrolizumab. Although our findings do not permit causal inference, these findings underscore the necessity for sustained hepatic monitoring, risk stratification, and appropriate therapeutic management."

Journal • Observational data • Immunology • Oncology

WHO updates essential medicines list to include key cancer... (CNBC-TV18) - "Atezolizumab and cemiplimab are now available as treatment choices for metastatic cervical, colorectal, and non-small-cell lung cancers, while pembrolizumab has been added as a first-line monotherapy....It also features Merck's best-selling cancer immunotherapy medication, Keytruda, which is used to treat colorectal, cervical, and metastasised non-small cell lung cancers."

Commercial • Cervical Cancer • Colorectal Cancer • Non Small Cell Lung Cancer