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

Fianlimab + Libtayo: Data from P3 trial (NCT05352672) for 1L metastatic melanoma in Q4 2025/Q1 2026 (Regeneron Pharmaceuticals) - Q2 2025 Results

P3 data • Melanoma • Oncology

Libtayo: "LIBTAYO has become Regeneron’s latest internally-discovered drug to reach >$1B in annual net sales" (Regeneron Pharmaceuticals) - Q2 2025 Results: "Continuing to grow market share in monotherapy and in combination with chemotherapy"

Commercial • Basal Cell Carcinoma • Cervical Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Thoracic Cancer

Is immunotherapy safe and effective in patients with VEXAS syndrome? (PubMed, J Immunother Cancer) - "Further, there is a lack of data about their role in controlling the UBA1 clones. In this clinical case, we report a successful use of cemiplimab in a patient with VEXAS syndrome and a concomitant diagnosis of metastatic squamous cell carcinoma."

IO biomarker • Journal • Oncology • Squamous Cell Carcinoma

Regeneron Reports Second Quarter 2025 Financial and Operating Results (GlobeNewswire) - "In July 2025, Lynozyfic was added to the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of multiple myeloma. The FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab) in adjuvant CSCC, with a target action date in October 2025."

NCCN guideline • PDUFA • Priority review • Multiple Myeloma • Squamous Cell Skin Cancer

Systemic treatment of immune checkpoint inhibitor-induced psoriasis: Inference-based guidance. (PubMed, J Eur Acad Dermatol Venereol) - "Although there is no direct evidence, we support the following saPs may be used to treat ICI-Ps without an appreciable loss of ICI effectiveness. Generally, it is not necessary to interrupt ICI therapy. When available, non-steroid saPs are preferred over systemic corticosteroids for the treatment of psoriasis."

Checkpoint inhibition • Journal • Dermatology • Immunology • Oncology • Psoriasis • Rheumatology • IL12A • IL23A • TYK2

ORAL IMMUNE-RELATED ADVERSE EVENTS ASSOCIATED WITH PD-1 AND PD-L1 INHIBITOR THERAPIES: A RETROSPECTIVE, SINGLE-INSTITUTION STUDY (MASCC-ISOO 2025) - "Methods We conducted a retrospective chart review including patients on PD-1 (nivolumab, pembrolizumab, cemiplimab) and PD-L1 (atezolizumab, avelumab, durvalumab) inhibitors who were treated with dexamethasone elixir, viscous lidocaine, or magic mouthwash. Four patients had oral biopsies showing ulcerated mucosa with granulation tissue, amyloidosis, and two results with lichenoid mucositis. Conclusions The results of this study may help clinicians with early identification and management of oral adverse events from PD-1/PD-L1 inhibitors and raise awareness of this important association."

Adverse events • Retrospective data • Amyloidosis • Dental Disorders • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor • Stomatitis • Xerostomia

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University of Southern California | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Checkpoint inhibition • Trial completion date • Trial primary completion date • Oncology • Skin Cancer • Solid Tumor

Efficacy and Safety of Immune Checkpoint Inhibitors in Kidney Transplant Recipients with Metastatic Cancer: A Systematic Review (WTC 2025) - "One trial reported better graft rejection outcomes (9.5%) with cemiplimab, and another trial found that modifying immunosuppressive regimens, like switching from calcineurin inhibitors to mTOR inhibitors and corticosteroids, maintained graft function in setting of ICI therapy. While ICIs have the potential to offer a therapeutic option for KTRs with metastatic cancer, they are also linked with a high risk of allograft rejection. Immunosuppressive regimen modification may decrease this risk, but additional studies are warranted to establish effective and safe treatment regimens."

Checkpoint inhibition • Clinical • Metastases • Review • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplant Rejection • Transplantation

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

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

Chemoimmunotherapy in Advanced, PD-1 Refractory Cutaneous Squamous Cell Carcinoma: Insights From Two Immunocompromised Patient Cases. (PubMed, Case Rep Oncol Med) - "The first patient, a 54-year-old man with HIV and recurrent metastatic cSCC, had rapid progression of disease while undergoing PD-1 inhibition with cemiplimab but later achieved tumor control when treated with pembrolizumab, carboplatin, and paclitaxel. The second patient, a 36-year-old man with cystic fibrosis and a history of lung transplantation, had no signs of response to cemiplimab but experienced a partial response when treated with cemiplimab, carboplatin, and paclitaxel. These cases suggest that combining chemotherapy with PD-1 inhibition may help overcome primary resistance to PD-1 therapy in advanced cSCC."

Journal • Cystic Fibrosis • Genetic Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Non-melanoma Skin Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

PROMOTING: Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen (clinicaltrials.gov) - P=N/A | N=144 | Not yet recruiting | Sponsor: IRCCS San Raffaele

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1b/2 study evaluating safety, efficacy and immune effects of TLR9 agonist cavrotolimod with anti-PD-1 antibodies among patients with advanced solid tumors. (PubMed, J Immunother Cancer) - P1b/2 | "Cavrotolimod had a manageable safety profile and showed clinical activity in anti-PD-(L)1 refractory cutaneous malignancies, suggesting potential for further development as an antitumor immunotherapy in combination with other agents."

Journal • P1/2 data • Fatigue • Genetic Disorders • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Review of the Management of Periocular Cutaneous Squamous Cell Carcinoma With Perineural Spread Over the Last Decade. (PubMed, Ophthalmic Plast Reconstr Surg) - "Immunotherapy demonstrated superior clinical outcomes in pcSCC with PNS, improving symptoms, nerve function, MRI findings, and survival rates compared to other treatment modalities."

Journal • Neuralgia • Non-melanoma Skin Cancer • Oncology • Pain • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • EGFR

A Comprehensive Narrative Review of the Challenges Surrounding Cutaneous SCC. (PubMed, Dermatol Ther (Heidelb)) - "While surgical excision is indicated for high-risk invasive cSCC, other treatments may include adjuvant radiation therapy (ART) and systemic therapies such as immune checkpoint inhibitors (cemiplimab, pembrolizumab, and cosibelimab) and epidermal growth factor receptor (EGFR) inhibitors (cetuximab). Despite advancements, inconsistent application of ART and biopsy limitations persist, highlighting the need for a standardized, evidence-based approach to cSCC management. This review highlights the challenges surrounding cSCC and the potential value of molecular tools to improve outcomes for patients with high-risk cSCC."

IO biomarker • Journal • Review • Genetic Disorders • Head and Neck Cancer • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

PD-1 monoclonal antibodies as an effective treatment for rare cutaneous malignancies: a case report. (PubMed, Front Oncol) - "The checkpoint inhibitors pembrolizumab and cemiplimab have been effective treatments for a number of cutaneous malignancies. These patients had minimal, if any toxicity associated with treatment and have each remained recurrence-free for over a year of follow up. The therapeutic potential of PD-1 monoclonal antibodies as a treatment for these rare skin malignancies warrants further evaluation in clinical trials."

Journal • Genetic Disorders • Oncology • Skin Cancer • Squamous Cell Skin Cancer

Neoadjuvant immunotherapy is associated with a recurrence free survival benefit versus active surveillance in patients with resected hepatocellular cancer (ESMO-GI 2025) - "In the NeoHCC cohort, nICIs regimens included single-agent nivolumab (18%), cemiplimab (15.6%), cabozantinib–nivolumab (9.4%), pembrolizumab (0.8%), atezolizumab–bevacizumab (5.6%), and nivolumab–ipilimumab (50.6%), with 30 (23%) patients also receiving postoperative ICI... nICI exposure is associated with improved RFS compared to active surveillance post resection. While limited by treatment heterogeneity and indirect reconstruction of RFS curves, our data warrant prospective testing of nICI in randomized trials to confirm RFS benefit."

Clinical • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Immune checkpoint inhibitors and venous thromboembolism in patients with head and neck cancer undergoing surgery. (PubMed, Immunotherapy) - "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. The composite rate of VTE in the study population was 3.7% and was higher in patients treated with ICIs (4.6% versus 2.9%; OR, 1.6; 95% CI, 1.1, 2.5). This study highlights the importance of risk stratification and risk reduction in the setting of increasing ICI use for patients with HNC undergoing surgery."

Checkpoint inhibition • Journal • Cardiovascular • Head and Neck Cancer • Hematological Disorders • Oncology • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

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 18 months' 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 3 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 2 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