Regeneron's PD-1 Inhibitor Libtayo Receives FDA Approval as First Adjuvant Immunotherapy for High-Risk Cutaneous Squamous Cell Carcinoma

On October 8 local time, Regeneron announced that the U.S. FDA had approved the PD-1 inhibitor Libtayo®.(Cemiplimab-rwlc) The new indication has been approved for marketing in China, forAdult Cutaneous Squamous Cell Carcinoma with Higher Risk of Recurrence After Surgery and Radiation Therapy (CSCC) Patient's Adjuvant Therapy. The press release pointed out that this isThe first and only immunotherapy approved for adjuvant treatment of CSCC with a high risk of recurrence after surgery and radiation therapy。

Screenshot source: RegeneronOfficial Website

The FDA approval was based on data from the pivotal Phase III trial C-POST, which was designed to evaluate the efficacy and safety of Libtayo compared to placebo in patients with CSCC who are at high risk of recurrence after surgery and radiation therapy. The C-POST study results were published in The New England Journal of Medicine and presented at the 2025 ASCO Annual Meeting.

C-POST StudyThe results showed that, compared with placebo,Libtayo Reduced Risk of Disease Recurrence or Death by 68% in CSCC Patients at High Risk of Recurrence After Surgery and Radiation Therapy(Hazard Ratio [HR]: 0.32; 95% Confidence Interval [CI]: 0.20-0.51; p<0.0001)。

The safety profile of Libtayo is consistent with its known safety profile as a monotherapy for advanced cancer. As an adjuvant treatment for patients with high-risk CSCC, the most common adverse reactions are rash, pruritus, and hypothyroidism.

Patients with CSCC have a higher risk of recurrence after surgery and radiotherapy, and their prognosis is usually the worst. RegeneronThe press release pointed out,Libtayo is currently the standard treatment for advanced CSCC, and the approval of this new indication may change the treatment pattern for early-stage patients.

To date, Libtayo has been approved by regulatory authorities in more than 30 countries/regions for one or more indications, including the treatment of certain adult advanced basal cell carcinoma, and advanced or high-risk recurrent cases.CSCC , advanced non-small cell lung cancer, and advanced cervical cancer. In China, Libtayo has not been approved yet and is currently in Phase III clinical trials.

Since its first launch in 2018, the sales of Libtayo have been increasing year by year. In 2024, the global sales of this drug...An increase of 40.06% year-over-year,Exceeded one billion US dollars for the first time, reaching$12.168 billion, becoming another blockbuster drug under Regeneron.

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Editor: Xinyao

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