- Regeneron Canada received Health Canada approval for Libtayo (cemiplimab) as adjuvant treatment for adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation, marking the first approved adjuvant immunotherapy supported by a positive randomized trial in this setting.
- The approval is based on the Phase III C-POST trial, where Libtayo (n=209) reduced the risk of disease recurrence or death by 68% versus placebo (n=206) in 415 patients with high-risk CSCC after surgery and postoperative radiotherapy.
- Libtayo, a PD-1 inhibitor developed using Regeneron’s VelocImmune technology, demonstrated a safety profile consistent with previous studies. The most common adverse events included fatigue, diarrhea, pruritus, and rash, with treatment discontinuation due to adverse events reported in 9.8% of patients.
- Beyond the new approval, Libtayo is also indicated in Canada for advanced CSCC, locally advanced basal cell carcinoma, PD-L1-positive non-small cell lung cancer (alone or with chemotherapy), and recurrent or metastatic cervical cancer, further expanding its oncology footprint.
Takeaways:
The C-POST data – 68% reduction in recurrence or death versus placebo – gives Regeneron a strong clinical story to push Libtayo earlier in the treatment pathway, potentially expanding its footprint beyond metastatic/locally advanced CSCC into the adjuvant setting where recurrence risk is high and options have been limited. This can strengthen Libtayo’s position in Canadian oncology, support broader use across CSCC and its other indications, and create a more defensible lifecycle for the PD-1 inhibitor as guidelines and provincial coverage adapt to the new adjuvant standard.
Source: CA Newswire
