A 73-year-old Phoenix resident has remained cancer-free for more than a year after receiving an innovative immunotherapy treatment for advanced cutaneous squamous cell carcinoma (cSCC) at HonorHealth Research Institute in Scottsdale, Arizona.
Wayne Futch, who developed skin cancer following decades of sun exposure during his career in pool maintenance, had previously undergone more than 60 radiation treatments that failed to eliminate his cancer and resulted in the loss of his right eye.
"It disfigured my face," Futch said of the cancer and radiation treatment. "I knew I needed to take some different action, because the radiation was not getting rid of it."
In September 2023, Futch enrolled in a clinical trial (NCT05660384) evaluating WTX-124, an engineered derivative of Interleukin-2 (IL-2) developed by Werewolf Therapeutics. The results were remarkable – his tumor substantially shrank within just 8 weeks, and by 12 weeks, no detectable cancer remained.
Novel Mechanism of Action
WTX-124 represents a significant advancement in IL-2 therapy. While conventional IL-2 has proven anti-cancer efficacy, its clinical use has been limited by severe toxicity. The investigational drug is designed to remain inactive in circulation until it reaches the tumor microenvironment, where it selectively releases fully potent IL-2 to stimulate anti-tumor immunity with reduced systemic side effects.
"This drug is designed to be inactive upon infusion and only activated within the tumor, which means that we have the potential to get all of the benefit of IL-2 with much better safety," explained Justin Moser, M.D., an associate clinical investigator in HonorHealth Research Institute's Cancer Research Division and Associate Research Professor at Arizona State University School of Medicine and Advanced Medical Engineering.
The ongoing clinical trial is evaluating the drug both as a monotherapy and in combination with pembrolizumab in patients with immunotherapy-sensitive advanced or metastatic solid tumors who have failed standard treatments, including checkpoint inhibitor therapy.
Addressing a Growing Medical Need
Cutaneous squamous cell carcinoma is the second most common form of skin cancer, affecting the outer layer of skin. While most cases are treatable when detected early, advanced or metastatic disease presents significant challenges.
More than 1 million U.S. patients across all stages are diagnosed annually, with approximately 40,000 cases advancing to difficult-to-treat stages. Nearly 7,000 patients succumb to the disease when it becomes advanced or metastatic.
The incidence of cSCC has tripled over the past three decades due to an aging population, cumulative sun damage, and improved screening methods. For patients whose disease progresses despite checkpoint inhibitor therapy, there are currently no consistently effective treatment options.
Dr. Moser emphasized the significance of Futch's response: "We are overjoyed with the benefit that this patient received, especially given the very limited treatment options available for patients with immunotherapy refractory squamous cell carcinoma."
Patient Experience and Outlook
For Futch, the treatment has been life-changing. "I haven't had any cancer since the trial. I don't have any pain, other than the nerve damage done by the radiation," he said. "I feel confident that if the cancer ever comes back again, that they'll detect it and get rid of it, because they did it once already."
The clinical trial represents a collaborative effort across multiple institutions. HonorHealth Research Institute in Scottsdale is one of 10 national clinical trial sites, alongside locations in Tampa, Atlanta, Chicago, Indianapolis, Hackensack, Buffalo, Portland, Dallas, and San Antonio.
Expanding Treatment Options
Early-stage cSCC can typically be treated effectively with surgery, radiation, curettage (scraping), or cryotherapy (freezing with liquid nitrogen). For advanced disease, systemic therapy becomes necessary, with checkpoint inhibitors being the current standard of care.
However, for patients like Futch whose disease progresses despite these treatments, novel approaches like WTX-124 may offer new hope. The drug is part of Werewolf Therapeutics' PREDATOR® platform, which is designed to create conditionally activated molecules that stimulate both adaptive and innate immunity while addressing limitations of conventional proinflammatory immune therapies.
As Skin Cancer Awareness Month in May highlights the growing burden of skin cancers, this clinical trial demonstrates promising advances in treatment options for patients with limited alternatives. The continued development of targeted immunotherapies like WTX-124 may significantly improve outcomes for patients with advanced cSCC and potentially other solid tumors.
Patients, caregivers, and healthcare providers interested in learning more about the clinical trial can visit clinicaltrials.gov or contact HonorHealth Research Institute directly.
