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 30% of patients who had a PR in the combined analysis of patients who received LIBTAYO 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
The duration of response for this patient was 36.57+ months. At data cutoff, he had completed his treatment per protocol, and was in his 16th month of post-treatment follow-up. At this time, his response was still ongoing.

Actual clinical trial patient

History2

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

Clinical outcomes (as of data cutoff of March 2022)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -79.63% per RECIST 1.1
  • Time to response: 8 weeks (1.74 months)
  • Duration of response: 36.57+ months
Right auricular lesion

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
The duration of response for this patient was 20.5 months. At data cutoff, he had completed his treatment per protocol, and was in his 3rd month of post-treatment follow-up. At this time, he was no longer in response due to having progressive disease.

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 March 2022)2

  • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR
  • Best percentage change in target lesion(s): -97.73% per WHO Criteria
  • Time to response: 24 weeks (5.5 months)
  • Duration of response: 20.5 months
Cranial lesion

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
The duration of response for this patient was 28.81 months. At data cutoff, he had completed his treatment per protocol, and was in his 9th month of post-treatment follow-up. At this time, he was no longer in response due to having progressive disease.

Actual clinical trial patient

Auricular lesion

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 March 2022)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: 28.81 months

Examples from the 17% of patients who had a CR in the combined analysis of patients who received LIBTAYO in Study 1540.1 Individual patient responses may vary.

Left auricular lesion

Anterior 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
The duration of response for this patient was 15.6+ months. At data cutoff, he had completed his treatment per protocol, and was in his 6th month of post-treatment follow-up. At this time, his response was still ongoing.

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 March 2022)2

  • Best overall response: CR 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 (1.87 months)
  • Duration of response: 15.6+ months
Peri-clavicular lesion

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
The duration of response for this patient was 31.08+ months. At data cutoff, he had completed his treatment per protocol, and was in his 14th month of post-treatment follow-up. At this time, his response was still ongoing.

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 March 2022)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: 31.08+ months
  • *These patients received LIBTAYO 3 mg/kg Q2W dosing; please refer to the study design for recommended dosage for LIBTAYO.

LIBTAYO Patient Cases
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  • 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.