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Regeneron and Sanofi's Libtayo (cemiplimab) Receive the EC's Approval as 1L Treatment for Advanced Basal Cell Carcinoma

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Regeneron and Sanofi's Libtayo (cemiplimab) Receive the EC's Approval as 1L Treatment for Advanced Basal Cell Carcinoma

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  • The EC approval is based on data from an ongoing P-II trial evaluating Libtayo in 119 patients with LA BCC or metastatic BCC (nodal or distant) previously treated with an HHI to date
  • Results: patients treated with advanced or m-BCC showed median follow-up (16 & 9mos.); ORR (32% & 29%)- DOR (≥ 6 mos.) in ~ 90% of patients across both group & median DOR has not been reached
  • Libtayo is a mAb targeting PD-1 on T-cells & is now approved for 3 advanced cancers in the EU- following EC's concurrent approval of Libtayo as 1L treatment for advanced NSCLC whose tumor cells have ≥50% PD-L1 expression & no EGFR- ALK or ROS1 aberrations

  | Ref: Regeneron | Image: Investros Business Daily

Click here to­ read the full press release 

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