LIBTAYO demonstrated meaningful tumor reduction in clinical trial patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who were not candidates for curative surgery or curative radiation1,2

Patient responses

These are examples from the 31% of patients who had a partial response in clinical trials. Individual patient responses may vary.

Partial response
  • laCSCC
  • Not a candidate for curative surgery or curative radiation
  • 70-year-old male
Cranial lesion
Screening
Image of cranial lesion at the time of screening
After 16 weeks
Image of cranial lesion after 16 weeks of LIBTAYO treatment
After 24 weeks
Image of cranial lesion after 24 weeks of LIBTAYO treatment
After 32 weeks
Image of cranial lesion after 32 weeks of LIBTAYO treatment
Auricular lesion
Screening
Image of auricular lesion at the time of screening
After 16 weeks
Image of auricular lesion after 16 weeks of LIBTAYO treatment
After 24 weeks
Image of auricular lesion after 24 weeks of LIBTAYO treatment
After 32 weeks
Image of auricular lesion after 32 weeks of LIBTAYO treatment
Auricular lesion (enlarged view)
Screening
Enlarged image of auricular lesion at the time of screening
After 16 weeks
Enlarged image of auricular lesion after 16 weeks of LIBTAYO treatment
After 24 weeks
Enlarged image of auricular lesion after 24 weeks of LIBTAYO treatment
After 32 weeks
Enlarged image of auricular lesion after 32 weeks of LIBTAYO treatment
History
  • 70-year-old male
Eligibility
  • Locally advanced CSCC
Clinical outcomes (as of data cutoff October 27, 2017)
  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by independent central review
  • Best percent change in target lesion(s): –91.9 per WHO Criteria
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Partial response
  • laCSCC
  • Not a candidate for curative surgery or curative radiation
  • 57-year-old male
Auricular lesion
Screening
Image of auricular lesion at the time of screening
After 16 weeks
Image of auricular lesion after 16 weeks of LIBTAYO treatment
After 24 weeks
Image of auricular lesion after 24 weeks of LIBTAYO treatment
After 32 weeks
Image of auricular lesion after 32 weeks of LIBTAYO treatment
After 40 weeks
Image of auricular lesion after 40 weeks of LIBTAYO treatment
History
  • 57-year-old male
  • Prior radiotherapy and chemotherapy (regimen: carboplatin and paclitaxel)
Eligibility
  • Locally advanced CSCC
Clinical outcomes (as of data cutoff October 27, 2017)
  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by independent central review
  • Best percent change in target lesion(s): –95 per WHO Criteria
  • Illustrates reepithelialization of ulceration
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Partial response
  • mCSCC
  • 85-year-old male
Supraclavicular lesion
Screening
Image of supraclavicular lesion at the time of screening
After 8 weeks
Image of supraclavicular lesion after 8 weeks of LIBTAYO treatment
After 24 weeks
Image of supraclavicular lesion after 24 weeks of LIBTAYO treatment
After 40 weeks
Image of supraclavicular lesion after 40 weeks of LIBTAYO treatment
History
  • 85-year-old male
  • 3 prior radiotherapy regimens
Eligibility
  • Metastatic CSCC
Clinical outcomes (as of data cutoff October 27, 2017)
  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by independent central review
  • Best percent change in target lesion(s): –80.7 per RECIST 1.1
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Partial response
  • mCSCC
  • 66-year-old male
Clavicular lesions
Screening
Image of periclavicular lesions at the time of screening
After 8 weeks
Image of periclavicular lesions after 8 weeks of LIBTAYO treatment
After 24 weeks
Image of periclavicular lesions after 24 weeks of LIBTAYO treatment
After 48 weeks
Image of periclavicular lesions after 48 weeks of LIBTAYO treatment
History
  • 66-year-old male
Eligibility
  • Metastatic CSCC
Clinical outcomes (as of data cutoff October 27, 2017)
  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by independent central review
  • Best percent change in target lesion(s): –71.1 per RECIST 1.1
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Partial response*
  • laCSCC
  • Not a candidate for curative surgery or curative radiation
  • 65-year-old male
Anterior auricular lesion
Screening
Image of anterior auricular lesion at the time of screening
After 8 weeks
Image of anterior auricular lesion after 8 weeks of LIBTAYO treatment
After 16 weeks
Image of anterior auricular lesion after 16 weeks of LIBTAYO treatment
After 32 weeks
Image of anterior auricular lesion after 32 weeks of LIBTAYO treatment
History
  • 65-year-old male
Eligibility
  • Locally advanced CSCC
Clinical outcomes (as of data cutoff October 27, 2017)
  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by independent central review
  • Best percent change in target lesion(s): –100 per WHO Criteria
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  • *In order to characterize responses as complete, when possible, composite evaluation of target lesions by both digital medical photography (WHO Criteria) and radiology (RECIST 1.1) was performed, in addition to evaluation of nontarget lesions and appearance of new lesions. This patient did not meet all of the criteria necessary to be classified as an overall complete response.
  • CR, complete response; laCSCC, locally advanced CSCC; mCSCC, metastatic CSCC; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; WHO, World Health Organization.
Selected safety information
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Data on file. Regeneron Pharmaceuticals Inc.