PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Alliance trial shows dual immunotherapy improves progression-free survival in advanced squamous cell skin cancer

Avelumab plus cetuximab combination meets primary endpoint in phase II trial A091802, presented at ASCO 2025 and published in Journal of Clinical Oncology

2025-05-31
(Press-News.org) May 31, 2025 — A phase II clinical trial led by the Alliance for Clinical Trials in Oncology has met its primary endpoint, demonstrating that the combination of avelumab and cetuximab improved progression-free survival (PFS) compared to avelumab alone in patients with advanced cutaneous squamous cell carcinoma (cSCC). The results, presented as an oral abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and published in the Journal of Clinical Oncology, suggest a promising new approach for patients with this aggressive form of skin cancer.

“These results show that combining immune checkpoint inhibition targeting the PD-1: PD-L1 pathway with avelumab plus EGFR-targeted IgG1 monoclonal antibody cetuximab can provide meaningful clinical benefit compared to avelumab alone for patients with advanced cSCC,” said Dan Zandberg, MD, principal investigator and Director of Head and Neck and Thyroid Cancer Disease Sections at UPMC Hillman Cancer Center. “It opens the door to future research and new strategies for improving outcomes in this difficult disease.”

Cutaneous squamous cell carcinoma is one of the most common cancers in the United States, with approximately 700,000 to 1 million new cases diagnosed annually. While most cases are treatable, over 12,500 cases progress to nodal or distant metastases each year, contributing to an estimated 2,000 to 8,000 deaths annually.

Approved immune checkpoint inhibitors, cemiplimab and pembrolizumab have advanced the treatment landscape, but many patients still experience disease progression. Preclinical research suggests that combining blockade of the PD-1: PD-L1 pathway plus an IgG1 monoclonal antibody like cetuximab, which targets EGFR and activates innate immunity via antibody-dependent cellular cytotoxicity (ADCC), may create a synergistic effect.

The trial (Alliance A091802) was designed to evaluate whether this dual mechanism could improve PFS. Patients were randomized to one of two groups: avelumab monotherapy every two weeks or combination of avelumab plus cetuximab, also given every two weeks. Patients progressing on avelumab alone were allowed to cross over to combination therapy, allowing for evaluation of efficacy in both frontline and immunotherapy refractory settings.

From 2019 to 2023, the study enrolled 60 patients with advanced cSCC in the United States; 57 were evaluable. The median age of participants was 72 years. The majority were white (96.5%), and male (91.2%), all patients were HIV-negative, and 75.4% expressed PD-L1. Most tumors (84.2%) originated in the head or neck region, and 47.1% of patients had distant metastases. Baseline characteristics were balanced across treatment groups, and the randomization was stratified by PD-L1 status.  The combination of avelumab and cetuximab significantly improved the primary endpoint of PFS compared to avelumab alone. The median PFS was 11.1 months (95% confidence interval [CI]: 7.6–not reached [NR]) in the avelumab plus cetuximab group compared to 3.0 months (95% CI: 2.7-13.6) in the avelumab alone group, with a hazard ratio (HR) of 0.48 (95% CI: 0.23–0.97, p = 0.018).

Nine patients in the avelumab monotherapy arm crossed over to the avelumab plus cetuximab group and the median PFS after crossover was 11.3 months (5.8-NR).  The median overall survival (OS) of the avelumab plus cetuximab group was not reached (25.2‒NR) compared to the avelumab group which was 35.8 mo (18.6‒NR) HR 0.78 (0.34‒1.80) p = 0.279 The confirmed objective response rate (ORR) was 27.6.% in the avelumab and cetuximab group and 21.4% in the avelumab alone group.

Side effects related to treatment occurred in 93% of patients who received avelumab plus cetuximab; and in 78.6% of those who received avelumab. More serious side effects (grade 3 or higher) were seen in 48.3% of patients receiving avelumab plus cetuximab, and in 21.5% of those receiving avelumab treatment. The most common serious side effects in the combination group were rash (20.7%) and infusion related reactions (20.7%). There were no deaths related to treatment or unexpected toxicity.

Alliance A091802 is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded national clinical trials network (NCTN)  as part of a collaboration with EMD Serono, a business of Merck KGaA, Darmstadt, Germany, who provided avelumab and trial support. To learn more about the study, visit ClinicalTrials.gov.

[Support by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology); U24CA196171; U10CA180868 (NRG Oncology); U10CA180888 (SWOG); and EMD Serono, a business of Merck KGaA, Darmstadt, Germany]

 

# # #


Reference: Alliance A091802: Phase II randomized trial of avelumab plus cetuximab versus avelumab alone in advanced cutaneous squamous cell carcinoma of the skin (cSCC). A full description of this clinical trial can be found at https://clinicaltrials.gov/study/NCT03944941.

The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting over 25,000 cancer specialists at 115 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network (NCTN) and a leading research base for the NCI Community Oncology Research Program (NCORP), the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes over 1.5 million samples, collected over the past 30 years. Learn more at www.AllianceforClinicalTrialsinOncology.org

END



ELSE PRESS RELEASES FROM THIS DATE:

Insights from immunotherapy trial inform new approaches to treating advanced skin cancer

2025-05-31
In patients with an advanced type of skin cancer called cutaneous squamous cell carcinoma (cSCC), those who received the combination of the immunotherapy drug avelumab and targeted agent cetuximab had almost four times longer median progression-free survival compared to patients who received avelumab alone, according to the results of a phase 2 trial presented today at the American Society of Clinical Oncology (ASCO) meeting and concurrently published in the Journal of Clinical Oncology. “It is both an honor and humbling to develop clinical trials ...

Genome breakthrough reveals secrets behind rapid growth and invasiveness of tropical vine Merremia boisiana

2025-05-31
Merremia boisiana, a member of the Convolvulaceae family, a fast-growing vine native to tropical rainforests and known for its vibrant golden flowers and astonishing climbing ability, grows at speeds exceeding 12 cm per day, often overwhelming native vegetation and disrupting forest ecosystems. Despite its ecological importance and genetic proximity to economically vital crops like sweet potato (Ipomoea batatas), little was known about its genomic makeup until now. A study (DOI:10.48130/tp-0025-0007) published in Tropical Plants on 24 March 2025 by Fei Chen and Wenquan Wang’s team, Hainan University, marks a significant leap ...

Transforming the certification process of 3D-printed critical components

2025-05-30
At present, it takes an average of 18 months for a supercomputer to evaluate a single 3D part and accurately predict its lifespan or expected date of failure. The Defense Advanced Research Projects Agency (DARPA)’s Structures Uniquely Resolved to Guarantee Endurance (SURGE) program has tasked grantees with compressing this evaluation time to three days and significantly simplifying the process so that it can be performed on a laptop computer.  Four members of the Texas A&M University faculty have responded to that ...

UC Davis clinical trial shows biomarkers hold clue in treating aggressive prostate cancer

2025-05-30
Many men with aggressive prostate cancer can experience a high rate of recurrence despite treatment. A new Phase 2 clinical trial at UC Davis Comprehensive Cancer Center unveiled clues as to why these patients are doing poorly and may offer hope in the form of targeted therapy. The findings will be presented at the annual American Society of Clinical Oncology (ASCO) conference on June 3 in Chicago. . Pilot trial sheds new clues                                                                                                                                        ...

UT Health San Antonio researchers discover new links between heart disease and dementia

2025-05-30
SAN ANTONIO, May 30, 2025 – People who are at higher risk for heart disease also seem more likely to develop dementia. And research led by The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has discovered new associations between various lipid, or fat, levels in the blood and the risk of developing Alzheimer’s disease, the most common cause of dementia worldwide. The findings mean that using blood lipid profiles could help better understand, predict and possibly even prevent the disease in the future. In more than 800 older adults who were part of the long-running Framingham Heart Study, the researchers ...

AADOCR announces new SCADA/Dentsply Sirona Research Award

2025-05-30
Alexandria, VA – AADOCR and the Student Competition for Advancing Dental Research and its Application (SCADA) Alumni Association are pleased to announce the AADOCR SCADA/Dentsply Sirona Research Award. The new award was created to support dentist-scientists, including SCADA program alumni, in their research careers. The award’s immediate goal is to support early-stage dentist-scientists such as post-doctoral scholars and pre-tenure faculty members, with a long-term objective of increasing the number of successfully funded dentist-scientists ...

Mass General Brigham researchers present key findings at ASCO

2025-05-30
Researchers from Mass General Brigham will present research discoveries and outcomes from clinical trials in cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30-June 3, in Chicago. ASCO brings together leading experts in clinical oncology to share the latest breakthroughs in cancer research, science and medicine. Presentations from Mass General Brigham investigators include an update on the INCIPIENT trial (using CAR-T in patients with glioblastoma), advances in skin cancer and gynecologic cancer treatment, a new way to radiate multiple brain metastases at the same time, and an app created to help caregivers ...

Student researchers put UTA on national stage

2025-05-30
University of Texas at Arlington biochemistry major Debby Sunday showcased her research at a recent American Chemistry Society conference at East Texas A&M in Commerce. Her findings on photosynthesizers and bacteria earned second place in the undergraduate competition. “This was the first research conference I ever attended, and my experience was very educational,” said Sunday, a graduate of Lake Ridge High School in Mansfield. “Other chemists from across the metroplex presented their various research, from inorganic chemistry to physical chemistry to biochemistry. Not ...

Hertz Foundation and Breakthrough Energy partner to advance climate and energy solutions

2025-05-30
The Hertz Foundation, a nonprofit dedicated to empowering the nation’s most promising innovators in science and technology, and Breakthrough Energy Discovery, a Breakthrough Energy platform focused on pre-venture, early-stage clean technology, have announced a new partnership to advance transformative climate and energy solutions. This collaboration brings together two organizations with a shared commitment to advancing scientific innovation and supporting exceptional talent. By connecting Breakthrough Energy’s innovation platform with the Hertz Foundation’s renowned community of scientific leaders, the partnership will create new opportunities ...

New study reveals how tiny insects detect force

2025-05-30
HUNTINGTON, W.Va. — A newly published study in the Journal of Neurophysiology reveals how blow flies (Calliphora vicina)—despite their minimal body weight—reliably detect forces through specialized sensory organs in their legs. The research offers new insights into insect biomechanics and presents promising applications for the design of next-generation walking robots.  Researchers at Marshall University and West Virginia University examined the behavior of campaniform sensilla—strain-detecting ...

LAST 30 PRESS RELEASES:

Poll: Amid multi-state measles outbreak, 79% of Americans support routine childhood vaccine requirements

Artificial intelligence in miniature format for small devices

Early blood-thinning treatment safe and effective for stroke patients

New gene therapy delivery device could let hospitals create personalized nanomedicines on-demand

Membrane or metabolism, which came first?

Jackpot! Gold from e-waste opens a rich vein for miners and the environment

EPFL scientists build first self-illuminating biosensor

Oxford scientists develop new technique for capturing ultra-intense laser pulses in a single shot

Inflammatory cells remain in the blood after treatment of severe asthma

New insights into seasonal shifts in sleep

Estimating microbial biomass from air-dried soils: A safer, scalable approach

AI in healthcare needs patient-centred regulation to avoid discrimination – new commentary

A good soak in a hot tub might beat a sauna for health benefits

Surgery plus speech therapy linked to improved language after stroke

GP performance pay fails to drive lasting changes in quality of care

Focusing on weight loss alone for obesity may do more harm than good

In sub-Saharan Africa, 1 in 6 cancer medications found to be defective

Newborns require better care to improve survival and long-term health

EMBARGOED: New study shows almost half of hospital patients in Malawi and Tanzania have multiple health conditions

People with symptoms of chronic lung disease in Kenya face ‘catastrophic’ health costs

Sylvester Cancer Tip Sheet - June 2025

UC Davis and Proteus Space to launch first-ever dynamic digital twin into space

Olympians' hearts in focus: groundbreaking study reveals elite rowers' surprising AFib risk

Common medicine for autoimmune diseases works on giant cell arteritis

Your neighborhood may be tied to risk of inflammation, dementia biomarkers

AAN issues position statement on possible therapies for neurological conditions

Liver organoid breakthrough: Generating organ-specific blood vessels

LRA awards 2025 Lupus Insight Prize to Dr. Deepak Rao for uncovering key drivers of immune imbalance in lupus

Terasaki Institute’s Dr. Yangzhi Zhu recognized as 2024 Biosensors Young Investigator Award Recipient

NAU researchers launch open-source robotic exoskeleton to help people walk

[Press-News.org] Alliance trial shows dual immunotherapy improves progression-free survival in advanced squamous cell skin cancer
Avelumab plus cetuximab combination meets primary endpoint in phase II trial A091802, presented at ASCO 2025 and published in Journal of Clinical Oncology