Regeneron Pharmaceuticals, Inc. and Sanofi announced that positive updated data for Libtayo® (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be shared at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved for patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation in the U.S.
These data from the pivotal Phase 2 EMPOWER-CSCC-1 trial include the primary analysis for the locally advanced CSCC group and longer-term data from the metastatic CSCC group. Together, they provide updated Libtayo efficacy and safety outcomes following its approval by the U.S. Food and Drug Administration (FDA) in September 2018 and will be shared alongside two additional joint Regeneron-Sanofi abstracts on CSCC.
“The data presented at this meeting offer longer-term results in more than twice as many patients as initially reported for the Phase 2 trial at ASCO last year, confirming how Libtayo can lead to beneficial and significant treatment outcomes for patients with advanced CSCC,”
said Israel Lowy, M.D., Ph.D., Head of Clinical and Translational Sciences, Oncology at Regeneron.
“The medical community’s rapid adoption of Libtayo since its approval last September is a testament to its strong body of evidence and the great unmet need in advanced CSCC.”
Among patients with locally advanced CSCC, the most common adverse events (AEs) were fatigue (42%), diarrhea and pruritus (both 27%) and nausea (22%). Grade 3 or higher immune-related AEs occurred in 10% of patients; one patient died due to an unknown cause assessed as treatment-related. Among patients with metastatic CSCC, the most common AEs were diarrhea (29%), fatigue (25%) and nausea (24%). Investigator-assessed Grade 3 or higher immune-related AEs occurred in 14% of patients.
In addition to the EMPOWER-CSCC-1 data, Regeneron and Sanofi are also sharing results from the largest retrospective data set of patients with metastatic or locally advanced CSCC who were treated with chemotherapy or an EGFR (epidermal growth factor receptor) inhibitor but who did not receive anti-PD-1 or anti-PD-L1 therapy.
Regeneron and Sanofi joint presentations at ASCO include:
Poster Discussion and Poster Sessions
- Primary analysis of Phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (Dr. Michael Migden; Saturday, June 1; Poster Display: 1:15-4:15 PM; Poster Discussion: 4:30-6:00 PM)
- Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3; Poster Display: 1:15-4:15 PM)
- Treatment patterns and outcomes among patients with advanced cutaneous squamous cell carcinoma in a U.S. community oncology setting (Dr. C. Lance Cowey; Publication Only)
- Patterns of major surgeries among patients diagnosed with cutaneous squamous cell carcinoma (Chieh-I Chen; Publication Only)
Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Libtayo was invented by Regeneron using the company’s proprietary VelocImmune® technology that yields optimized fully-human antibodies.