PD-L1 IHC 22C3 pharmDx (SK006): The FIRST PD-L1 assay clinical trial-proven to aid in the identification of NSCLC patients for treatment with LIBTAYO (cemiplimab)
Product Information
PD‑L1 Testing in NSCLC
Clinical Trial‑Proven
Results in NSCLC
Benefits of PD‑L1 IHC
22C3 pharmDx in NSCLC
PD‑L1 IHC 22C3 pharmDx can help identify NSCLC patients for treatment with LIBTAYO1,2
  • Lung cancer is the leading cause of cancer‑related mortality in Europe,3 and NSCLC accounts for ~85% of all lung cancer cases4
  • The Study 1624 phase 3 clinical trial studied the efficacy of LIBTAYO, an anti‑PD‑1 monotherapy, in patients with locally advanced or metastatic NSCLC and no EGFR, ALK, or ROS1 abberations whose tumors exhibited PD‑L1 expression level TPS ≥ 50%*1,2
  • In Study 1624, PD‑L1 IHC 22C3 pharmDx was used to determine PD‑L1 expression level1
PD-L1 testing provides a direct assessment of PD-L1 expression, which is a biomarker for response to anti-PD-1 therapy in NSCLC


* Review the PD-L1 IHC 22C3 pharmDx Instructions for Use for more information regarding the Study 1624 phase 3 clinical trial

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PD‑L1 IHC 22C3 pharmDx:
Product Overview Page
Trust the FIRST PD-L1 assay clinical trial-proven to determine PD-L1 expression in patients with NSCLC for treatment with LIBTAYO1,2
  • PD-L1 IHC 22C3 pharmDx was the assay used to assess PD‑L1 expression to select patients for treatment with LIBTAYO in Study 16241,2

  • In the TPS ≥ 50% population, the median OS for LIBTAYO was not reached† (95% CI: 17.9–not evaluable) compared to 14.2 months (95% CI: 11.2–17.5 months) for chemotherapy1

Guidelines recommend PD-L1 testing at diagnosis for patients with advanced NSCLC
Median Overall Survival (OS) of Patients in Study 1624


† At the pre‑defined study endpoint, the median OS of the LIBTAYO arm in the TPS ≥ 50% population was not reached: meaning, more than 50% of treated patients were still alive

PD-L1 IHC 22C3 pharmDx NSCLC Interpretation Manual Image of the PD-L1 IHC 22C3 pharmDx NSCLC Interpretation Manual Refer to the NSCLC Interpretation Manual to review validated scoring guidelines that can aid in the identification of NSCLC patients for treatment with LIBTAYO
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PD-L1 IHC 22C3 pharmDx NSCLC Interpretation Training Program Image of the PD-L1 IHC 22C3 pharmDx NSCLC Training Program Get the training that may help you accurately evaluate and score PD‑L1 expression in patients with NSCLC
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Online Atlas of Stains for NSCLC: PD‑L1 IHC 22C3 pharmDx Image of the PD-L1 IHC 22C3 pharmDx NSCLC Online Atlas of Stains Use the Online Atlas of Stains for NSCLC to increase your familiarity with PD‑L1 staining in NSCLC specimens
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Choose PD‑L1 IHC 22C3 pharmDx — the FIRST PD‑L1 assay clinical trial‑proven with LIBTAYO
  • The PD-L1 assay used in the pivotal LIBTAYO clinical trial (Study 1624) in advanced NSCLC1,2
  • The FIRST clinical trial-proven companion diagnostic CE-IVD–marked as an aid in identifying NSCLC patients for treatment with LIBTAYO1,2
  • In an ALL-INCLUSIVE kit that delivers reproducible, repeatable, and clinically validated results for diagnostic confidence1
Test for PD-L1 with PD-L1 IHC 22C3 pharmDx upon diagnosis to better inform patient management and care

LIBTAYO is a registered trademark of Regeneron Pharmaceuticals, Inc.

References: 1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2021. 2. Libtayo [Summary of Product Characteristics]. European Medicines Agency; 2021. 3. World Health Organization. Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf (accessed June 25, 2021). 4. Wood, R.; Taylor-Stokes, G.; Smith, F.; Chaib, C. The Humanistic Burden of Advanced Non-Small Cell Lung Cancer (NSCLC) in Europe: A Real-World Survey Linking Patient Clinical Factors to Patient and Caregiver Burden. Qual. Life Res. 2019, 28 (7), 1849–1861. 5. Brahmer, J. R.; Govindan, R.; Anders, R. A.; Antonia, S. J.; Sagorsky, S.; Davies, M. J.; Dubinett, S. M.; Ferris, A.; Gandhi, L.; Garon, E. B.; Hellmann, M. D.; Hirsch, F. R.; Malik, S.; Neal, J. W.; Papadimitrakopoulou, V. A.; Rimm, D. L.; Schwartz, L. H.; Sepesi, B.; Yong Yeap, B.; Rizvi, N. A.; Herbst, R. S. The Society for Immunotherapy of Cancer Consensus Statement on Immunotherapy for the Treatment of Non-Small Cell Lung Cancer (NSCLC). J. Immunother. Cancer 2018, 6 (1), 75. 6. Hanna, N.; Johnson, D.; Temin, S.; Baker, S.; Brahmer, J.; Ellis, P. M.; Giaccone, G.; Hesketh, P. J.; Jaiyesimi, I.; Leighl, N. B.; Riely, G. J.; Schiller, J. H.; Schneider, B. J.; Smith, T. J.; Tashbar, J.; Biermann, W. A.; Masters, G. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J. Clin. Oncol. 2017, 35 (30), 3484–3515. 7. Planchard, D.; Popat, S.; Kerr, K.; Novello, S.; Smit, E. F.; Faivre-Finn, C.; Mok, T. S.; Reck, M.; Van Schil, P. E.; Hellmann, M. D.; Peters, S. ESMO Guidelines Committee. Metastatic Non-Small Cell Lung Cancer: ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-Up. Ann. Oncol. 2018, 29 (Suppl 4), iv192–iv237.

D66806/01 2021AUG04

Review the PD-L1 IHC 22C3 pharmDx Intended Use
Intended Use