Regeneron, a leading pharmaceutical company, recently unveiled compelling data regarding the efficacy of its immunotherapy drug, Libtayo, in treating high-risk cutaneous squamous cell carcinoma (CSCC) as an adjuvant therapy. This development comes at a time when competing PD-1 inhibitor Keytruda faces challenges in the same area.
According to Regeneron’s findings presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Libtayo demonstrated remarkable results when administered post-surgery or radiotherapy. The study revealed a significant 68% reduction in the risk of disease recurrence or death compared to a placebo.
Dr. Israel Lowy, head of oncology at Regeneron’s clinical development unit, emphasized the groundbreaking nature of these results, stating that
“Libtayo is the first and only immunotherapy to demonstrate a clinical benefit compared to standard care procedures like surgery and radiation alone.”
With CSCC being the second most prevalent form of skin cancer known for its high recurrence rates, this advancement holds immense promise for patients and healthcare providers seeking effective treatment options. The study showcased impressive outcomes with Libtayo producing an 87% disease-free survival rate over two years versus 64% in the placebo group.
Moreover, Regeneron highlighted an 80% decrease in locoregional recurrence risk and a 65% reduction in distant recurrence risk among patients receiving Libtayo. These results signify a significant leap forward in addressing unmet medical needs within the field of immunotherapies.
The positive reception towards Libtayo is further underscored by its commercial success. With sales reaching $1.2 billion in 2024 and forecasts predicting potential revenues of $2.6 billion by 2031, it stands as one of Regeneron’s flagship products.
In contrast, Keytruda faced setbacks during ASCO with disappointing outcomes in the adjuvant setting for CSCC treatment. Despite being a prominent player with sales soaring to $29.5 billion in 2024, Keytruda failed to exhibit substantial benefits akin to those seen with Libtayo.
Dr. Lowy remains optimistic about Libtayo’s trajectory and future expansions into new indications beyond CSCC adjuvant therapy. He envisions opportunities for neoadjuvant treatments and ongoing research exploring alternative administration methods for various stages of CSCC.
As the landscape of immunotherapies evolves rapidly, Regeneron’s focus on innovation and addressing critical gaps within cancer care positions them as frontrunners shaping the future of oncology treatments.
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