Advanced CSCC

Patient Case Studies

Meaningful tumor reduction in clinical trial patients with advanced CSCC1,2

Response in patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation1

Patient responses

These are examples from the 31% of patients who had a PR in the combined analysis of patients who received LIBTAYO 3 mg/kg Q2W in Study 1540.1 Individual patient responses may vary.

Supraclavicular lesion

Supraclavicular lesion

Screening

Supraclavicular lesion, screening image

After 8 weeks

Supraclavicular lesion, after 8 weeks image

After 56 weeks

Supraclavicular lesion, after 56 weeks image

Actual clinical trial patient

History2

  • 85-year-old male
  • Metastatic CSCC
  • Supraclavicular lesion with distant metastasis

Clinical outcomes (as of data cutoff of September 2018)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -74.9% per RECIST 1.1
  • Time to response: 8 weeks
  • Duration of response: 18.6+ months

Right auricular lesion

Screening

Right auricular lesion, screening image

After 24 weeks

Right auricular lesion, after 24 weeks image

After 88 weeks

Right auricular lesion, after 88 weeks image

Actual clinical trial patient

History2

  • 57-year-old male
  • Locally advanced CSCC
  • Clinical judgment was that tumor would be unlikely to respond to RT

Clinical outcomes (as of data cutoff of October 2018)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -96.5% per WHO Criteria
  • Time to response: 24 weeks (5.5 months)
  • Duration of response: 18.7+ months

Cranial lesion

Screening

Cranial lesion, screening image

After 16 weeks

Cranial lesion, after 16 weeks image

After 96 weeks

Cranial lesion, after 96 weeks image

Actual clinical trial patient

Auricular lesion

Screening

Auricular lesion, screening image

After 16 weeks

Auricular lesion, after 16 weeks image

After 96 weeks

Auricular lesion, after 96 weeks image

Actual clinical trial patient

History2

  • 70-year-old male
  • Locally advanced CSCC
  • MDT deemed that radiotherapy was contraindicated

Clinical outcomes (as of data cutoff of October 2018)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -99.6% per WHO Criteria
  • Time to response: 16 weeks (3.7 months)
  • Duration of response: 21.2+ months

Examples from the 15% of patients who had a CR in the combined analysis of patients who received LIBTAYO 3 mg/kg Q2W in Study 1540.1 Individual patient responses may vary.

Left auricular lesion

Screening

Left auricular lesion, screening image

After 8 weeks

Left auricular lesion, after 8 weeks image

After 64 weeks

Left auricular lesion, after 64 weeks image

Actual clinical trial patient

History2

  • 65-year-old male
  • Locally advanced CSCC
  • Anterior auricular lesion that would have required an auriculectomy

Clinical outcomes (end of study; as of data cutoff of October 2018)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -100% per WHO Criteria
  • Time to response: 8 weeks
  • Duration of response: 15.6+ months

Peri-clavicular lesion

Screening

Peri-clavicular lesion, screening image

After 24 weeks

Peri-clavicular lesion, after 24 weeks image

After 64 weeks

Peri-clavicular lesion, after 64 weeks image

Actual clinical trial patient

History2

  • 66-year-old male
  • Distant metastatic CSCC
  • Subcutaneous metastases
  • Cancer spread to the lymph nodes

Clinical outcomes (as of data cutoff of September 2018)2

  • Best overall response: CR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -100% per RECIST 1.1
  • Time to response: 24 weeks (5.5 months)
  • Duration of response: 16.6+ months

LIBTAYO Patient Cases
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The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1

  • CR=complete response; CSCC=cutaneous squamous cell carcinoma; ICR=independent central review; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; MDT=multidisciplinary team; PR=partial response; Q2W=every 2 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; RT=radiation therapy; WHO=World Health Organization.

laCSCC Patient Case Study: 57-year-old Male Not a Candidate for Curative Surgery or Curative Radiation

Description
Hear from medical oncologist Dr Sunandana Chandra and Mohs surgeon Dr Brent Moody as they discuss the study designs, and safety and efficacy results of clinical trials with LIBTAYO. Following, they will review the case study of an advanced CSCC patient who was not a candidate for curative surgery or curative radiation and his treatment journey with LIBTAYO.
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