再生元公布Libtayo辅助治疗高危皮肤鳞癌III期近4年随访数据，死亡风险降37%（OS仍不显著）

Regeneron Pharmaceuticals, Inc. (REGN) announced longer-term data from the Phase 3 C-POST trial, which includes nearly four years of follow-up, evaluating the PD-1 inhibitor Libtayo (cemiplimab) as adjuvant treatment for patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation.
Libtayo is a fully human anti-PD-1 monoclonal antibody developed using Regeneron's VelocImmune technology. Libtayo has been approved in over 30 countries for several cancer indications, including advanced BCC, advanced or recurrent high-risk CSCC, advanced non-small cell lung cancer (NSCLC), and advanced cervical cancer.
C-POST was a randomised, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy.
The trial enrolled 415 patients, who were randomised to receive Libtayo (n=209) or placebo (n=206) for up to 48 weeks. Participants received intravenous Libtayo 350 mg or placebo every three weeks for the first 12 weeks, followed by Libtayo 700 mg or placebo every six weeks for an additional 36 weeks.
Patients in the placebo arm whose disease recurred were eligible to cross over to Libtayo, while those initially assigned to Libtayo could be retreated upon recurrence occurring at least three months after their last adjuvant dose.
According to the company, the key findings include,
- With a median follow-up of 44 months, Libtayo demonstrated sustained disease-free survival (DFS) benefits versus placebo, along with a growing overall survival (OS) advantage.
- Specifically, Libtayo reduced the risk of death by 37% versus placebo at a median follow-up of 44 months (HR=0.63; 95% CI: 0.36-1.11), compared with a 22% reduction at 30 months (HR=0.78; 95% CI: 0.39-1.56) and a 14% reduction at 24 months (HR=0.86; 95% CI: 0.39-1.90), indicating an increasing survival benefit over time.
- An exploratory analysis of patients with baseline circulating tumour DNA (ctDNA) data (Libtayo, n=93; placebo, n=98) showed that adjuvant Libtayo improved disease-free survival (DFS) versus placebo regardless of minimal residual disease (MRD) status, supporting its potential benefit across a broad population of high-risk CSCC patients.
- Notably, patients who were MRD-negative at baseline and therefore considered at lower risk of recurrence experienced improved DFS with Libtayo versus placebo (HR=0.45; 95% CI: 0.22-0.95). A DFS benefit was also observed among MRD-positive patients, who are at higher risk of recurrence (HR=0.24; 95% CI: 0.07-0.86).
- The safety profile remained consistent with previously reported findings. Treatment-emergent adverse events (TEAEs) of any grade occurred in 94% of patients receiving Libtayo and 91% receiving placebo.
- Grade 3 or higher TEAEs were reported in 26% and 17% of patients, respectively, while treatment discontinuations due to TEAEs occurred in 10% and 3%. TEAEs resulting in death were reported in 2% of patients in each arm.
"These data provide compelling evidence of the long-term, durable benefit of adjuvant treatment with Libtayo in high-risk CSCC after surgery and radiation, further supporting Libtayo as a transformative standard of care for these patients," said Danny Rischin, the trial's lead investigator.
REGN has traded between $575.93 and $859.34 over the year. The stock closed Friday's trade (October 23, 2026) at $805.02, down 1.72%.
In overnight trading, REGN was down 0.12% at $804.06 as of writing.
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