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

Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial (IASLC-WCLC 2026) - P1 | "Surgery was feasible and no impact of neoadjuvant treatment on postsurgical healing was detected. Longer follow-up and additional pathological response data will be presented."

Clinical • IO biomarker • P1 data • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • CLDN6 • MAGEA4 • MAGEC1 • PD-L1 • PRAME

KRAS G12C Predicts Superior Outcomes With 1L Cemiplimab for Non-Squamous Ansclc With PD-L1 =50%: Data From EMPOWER-Lung 1 (IASLC-WCLC 2026) - P3 | "Conclusions : In this comprehensive genomic analysis of first-line cemiplimab for non-squamous aNSCLC with PD-L1 ≥50%, KRAS mutations, specifically KRAS G12C , identified a subset of patients deriving remarkable OS benefit from cemiplimab monotherapy. Pending confirmation in prospective trials, these findings provide a critical framework for evaluating whether adding KRAS G12C -targeted therapy to immune checkpoint inhibitors confers incremental benefit in the first-line setting, with implications for treatment sequencing and combination strategies."

IO biomarker • Tumor mutational burden • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • KEAP1 • KRAS • PD-L1 • ROS1 • STK11 • TMB • TP53

Complete AV Block From Septal Cardiac Metastases of Anal Squamous Carcinoma Managed With Leadless Pacing. (PubMed, JACC Case Rep) - "Leadless pacing can be a practical option for complete AV block in frail oncology patients. Cardiac metastases should be considered in new arrhythmias or conduction disturbances, particularly with septal lesions."

Journal • Anal Carcinoma • Cardiovascular • CNS Disorders • Infectious Disease • Oncology • Squamous Cell Carcinoma

Contemporary Multimodal Management of Cutaneous Malignancies: Surgery, Radiotherapy, Systemic Therapy, Molecular Targeting and Immunotherapy. (PubMed, Cancers (Basel)) - "The major unresolved issues are optimal sequencing, response-adapted perioperative treatment, resistance, biomarker validation and treatment of transplant, frail and other under-represented populations."

IO biomarker • Journal • Review • Tumor mutational burden • Basal Cell Carcinoma • Cutaneous Melanoma • Genetic Disorders • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation • NF1 • NRAS • PD-L1 • TMB

META-1: Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels (clinicaltrials.gov) - P2 | N=275 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2028 ➔ Dec 2028

Enrollment open • IO Companion diagnostic • Monotherapy • PD(L)-1 companion diagnostic • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

A Phase 1/2 study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti-PD-1) in patients with advanced solid tumors: Initial dose-escalation results (SITC 2022) - P1/2 | "Biomarker studies are ongoing. Clinical trial enrollment is ongoing; we are currently evaluating the 100mg cohort."

Clinical • Combination therapy • IO biomarker • P1/2 data • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD28 • EGFR

A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results. (ASCO 2024) - P1/2 | "MSS CRC is historically unresponsive to immunotherapy. REGN7075 is one of the first immune therapies to demonstrate clinical activity in pts with MSS CRC (including a pt with liver metastases), and dose escalation was completed through 900 mg with an acceptable safety profile and no DLTs. One pt experienced Grade 1 CRS, demonstrating differentiation from CD28 superagonists and CD3-targeting bsAbs."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD28 • EGFR • IFNG

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 | " This multicenter Phase II platform study randomizes patients with MSS stage II–III or oligometastatic stage IV CRC who are ctDNA-positive within 12 weeks of completing definitive therapy (surgery ± chemotherapy/chemoradiotherapy) to one of three arms: 1) Cemiplimab 350 mg IV q3w × 1 year; 2) Cemiplimab 350 mg + fianlimab 1600 mg IV q3w × 1 year; and 3) Cemiplimab 350 mg + REGN7075 2700 mg IV q3w × 1 year. Statistical design: Arm 1 follows a Simon two-stage design with up to 33 patients (α=0.047, power=0.80), and Arms 2 & 3 enroll up to 23 patients each (single-stage; α=0.05, power=0.78). Status: Enrollment began in September 2025 across NSABP Foundation sites and is ongoing."

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

PHASE 2 STUDY OF UBAMATAMAB ALONE OR IN COMBINATION WITH ADDITIONAL AGENTS IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER: TRIAL IN PROGRESS (IGCS 2026) - P2 | "Combination arms include ubamatamab + standard doses of bevacizumab (Arm B), triple immunotherapy (ubamatamab + cemiplimab + fianlimab; Arm C), and ubamatamab + pegylated liposomal doxorubicin (Arm D). Patients will receive sarilumab prophylaxis to mitigate CRS risk...Primary completion is December 2028. With limited immunotherapy options in PROC, ubamatamab may offer a novel approach."

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

Phase II Trial of Ubamatamab in MUC16-Expressing SMARCB1-Deficient Renal Medullary Carcinoma and Epithelioid Sarcoma (KCRS 2024) - "As proof of concept, a 20-year-old patient with metastatic SMARCB1-negative ES expressing high levels of serum CA125 achieved a durable (12+ months) partial response to ubamatamab after progressing on multiple prior therapies, including EZH2 inhibition with tazemetostat as well as antiPD1/CTLA4 immune checkpoint inhibition with nivolumab plus ipilimumab...Patients with disease progression on ubamatamab monotherapy during Stage I can proceed to stage II, which will evaluate the combination of ubamatamab with cemiplimab combination...Mucin 16 (cancer antigen 125) Expression in Epithelioid Sarcoma leads to Single-Patient Study with Bispecific T-Cell Engager Ubamatamab (Mucin16xCD3): A Bench-ToBedside Experience. Connective Tissue Oncology Society, Nov 16–19, 2022, Vancouver, Canada."

IO biomarker • P2 data • Cardiovascular • Kidney Medullary Carcinoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Respiratory Diseases • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • MUC16 • SMARCB1

R5668-ONC-1938: A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab (clinicaltrials.gov) - P1/2 | N=612 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Nov 2027 ➔ Nov 2028 | Trial primary completion date: Mar 2027 ➔ Nov 2028

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

C-Post Study of Adjuvant Cemiplimab for High-Risk Cutaneous Squamous Cell Carcinoma: Impact of Adjuvant Radiotherapy on Disease-Free Survival (ASTRO 2026) - P3 | "In this phase 3 study, adjuvant cemi demonstrated a DFS benefit vs pbo across all adjuvant RT subgroups assessed. (NCT03969004) Abstract 173 – Table 1: DFS with cemi vs pboH: Analyses per Adjuvant RT"

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

Regeneron - Adjuvant Treatment with LIBTAYO for Patients with Cutaneous Squamous Cell Carcinoma (CSCC) at High Risk of Recurrence After Surgery and Radiation (ASTRO 2026) - "Sponsored By Regeneron session DESCRIPTION Livestream: https://projection.zoom.us/j/89422478010?pwd=pGhugGVYaQDNP32atuXAN4F981FOvl.1"

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

Real-world outcomes with cemiplimab for advanced cutaneous squamous cell carcinoma (cSCC) in a UK tertiary cancer network (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Early response and treatment exposure in advanced cutaneous squamous cell carcinoma treated with cemiplimab: a real-world analysis (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Outcomes and Exploratory Role of the Neutrophil-to-Lymphocyte Ratio as a Predictive Biomarker (ESMO 2026) - No abstract available

Biomarker • Clinical • Metastases • Real-world • Real-world evidence • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Cemiplimab demonstrates durable activity in advanced cutaneous squamous cell carcinoma, including immunocompromised patients: Real-world outcomes from a UK tertiary centre (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Biomarker‑Driven Exploratory Clustering of Cytokine and Hematologic Profiles in a Phase II Trial of Metronomic Chemotherapy Plus Cemiplimab in R/M HNSCC (ESMO 2026) - No abstract available

Biomarker • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Trends in General Industry Payments to Radiation Oncologists: 2019-2024 (ASTRO 2026) - "The largest share of payments were for Space OAR/SpaceOAR VUE System - 10mL ($342,997.24, 5.7%) and Imfinzi ($252,459.64, 4.2%), followed by Pylarify ($181,236.41, 3.0%), Libtayo ($158,210.84, 2.6%) and Optune ($112,478.27, 1.9%). From 2019 to 2024, total practitioner general payments decreased, including among ROs. In 2024, consulting fees accounted for the largest share of radiation oncology payments, and a small number of drugs and medical devices contributed disproportionately to total drug- and medical device-related payments. Payments to ROs constitute a very small share of all payments recorded in the Open Payments Database."

Oncology • Sarcoma • Skin Cancer • Solid Tumor

C-Post Study of Adjuvant Cemiplimab for High-Risk Cutaneous Squamous Cell Carcinoma: Impact of Adjuvant Radiotherapy on Disease-Free Survival (ASTRO 2026) - P3 | "In this phase 3 study, adjuvant cemi demonstrated a DFS benefit vs pbo across all adjuvant RT subgroups assessed. (NCT03969004) Abstract 173 – Table 1: DFS with cemi vs pboH: Analyses per Adjuvant RT"

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

Impact of objective response on PROs in patients receiving cemiplimab/chemotherapy vs chemotherapy for aNSCLC: EMPOWER-Lung 3 Part 2 (ESMO 2026) - No abstract available

Clinical • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Randomized Phase 1b/2 Adaptive Platform Trial of Anti-NKG2A, Anti-CD73, or Anti-TIM-3 Antibodies in Combination With Cemiplimab in Adults With Previously Untreated Advanced PD-L1–High NSCLC (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KLRC1 • PD-L1

CEMI-LUNG, a European-based observational study to assess cemiplimab real world effectiveness and safety in patients with advanced non-small cell lung cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Observational data • Real-world • Real-world effectiveness • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ETOP ARCH: A randomised phase III trial of adjuvant cemiplimab in patients with resected stage II-IIIA NSCLC who have not received prior adjuvant chemotherapy (ESMO 2026) - No abstract available

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Real world outcomes of Cemiplimab in advanced cutaneous squamous cell carcinoma: a single centre audit of over 100 patients (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer