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Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

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  • The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation
  • Opinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat high-risk CSCC pts (N=415) for ~48wks.
  • Trial met its 1EP with a 68% reduction in disease recurrence & death risk, plus showed that 4% vs 17% & 5% vs 13% pts had locoregional or distant recurrence, respectively; data was published in The NEJM

Ref: Regeneron | Image: Regeneron | Press Release

Related News:- Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

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