M Dietel1, N Savelov2, R Salanova3, P Micke4, G Bigras5, T Hida6, J Antunez7, B Guldhammer Skov8, G Hutarew9, L F Sua10, H Akita11, O S H Chan12, B Piperdi13, T Burke14, S Khambata-Ford13, A C Deitz14. 1. Institute of Pathology, Charité, University Medicine Berlin, Berlin, Germany. Electronic address: manfred.dietel@charite.de. 2. Department of Pathology, Moscow City Oncology Hospital #62, Moscow, Russian Federation. 3. Department of Pathology, Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo, Buenos Aires, Argentina. 4. Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. 5. Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada. 6. Department of Thoracic Oncology, Aichi Cancer Center, Nagoya, Japan. 7. Pathology Department, University Hospital of Santiago de Compostela, La Coruña, Spain. 8. Department of Pathology, Rigshospitalet, Copenhagen, Denmark. 9. Institute of Pathology, University Hospital and Paracelsus Medical University Salzburg, Salzburg, Austria. 10. Department of Pathology and Laboratory Medicine, Clinical Research Center, Fundación Valle del Lili, Cali, Colombia. 11. Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 12. Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong. 13. Merck & Co., Inc., Kenilworth, NJ, USA. 14. Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
Abstract
OBJECTIVES: Tumor programmed death ligand 1 (PD-L1) expression is associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicenter, retrospective observational study to determine real-world prevalence of tumor PD-L1 expression in patients with NSCLC. MATERIALS AND METHODS: Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumor tissue block (≤5 years old) obtained before treatment were identified in 45 centers across 18 countries. Tumor samples from eligible patients were selected consecutively, when possible. PD-L1 expression was evaluated at each center using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA). RESULTS: Of 2617 patients who met inclusion criteria, 2368 (90%) had PD-L1 data; 530 (22%) patients had PD-L1 TPS ≥ 50%, 1232 (52%) had PD-L1 TPS ≥ 1%, and 1136 (48%) had PD-L1 TPS < 1%. The most common reason for not having PD-L1 data (n = 249) was insufficient tumor cells (<100) on the slide (n = 170 [6%]). Percentages of patients with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively were: 22%/52% in Europe; 22%/53% in Asia Pacific; 21%/47% in the Americas, and 24%/55% in other countries. Prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports from metastatic NSCLC studies. Among 1064 patients negative for both EGFR mutation and ALK alteration, the percentage with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively, were 27% and 53%. CONCLUSIONS: This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumor expression using the 22C3 pharmDx kit. Testing failure rate was low with local evaluation of PD-L1 TPS across a large number of centers. Prevalence of PD-L1 TPS ≥ 50% and TPS ≥ 1% among patients with stage IIIB/IV NSCLC was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations.
OBJECTIVES:Tumorprogrammed death ligand 1 (PD-L1) expression is associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicenter, retrospective observational study to determine real-world prevalence of tumorPD-L1 expression in patients with NSCLC. MATERIALS AND METHODS:Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumor tissue block (≤5 years old) obtained before treatment were identified in 45 centers across 18 countries. Tumor samples from eligible patients were selected consecutively, when possible. PD-L1 expression was evaluated at each center using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA). RESULTS: Of 2617 patients who met inclusion criteria, 2368 (90%) had PD-L1 data; 530 (22%) patients had PD-L1 TPS ≥ 50%, 1232 (52%) had PD-L1 TPS ≥ 1%, and 1136 (48%) had PD-L1 TPS < 1%. The most common reason for not having PD-L1 data (n = 249) was insufficient tumor cells (<100) on the slide (n = 170 [6%]). Percentages of patients with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively were: 22%/52% in Europe; 22%/53% in Asia Pacific; 21%/47% in the Americas, and 24%/55% in other countries. Prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports from metastatic NSCLC studies. Among 1064 patients negative for both EGFR mutation and ALK alteration, the percentage with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively, were 27% and 53%. CONCLUSIONS: This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumor expression using the 22C3 pharmDx kit. Testing failure rate was low with local evaluation of PD-L1 TPS across a large number of centers. Prevalence of PD-L1 TPS ≥ 50% and TPS ≥ 1% among patients with stage IIIB/IV NSCLC was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations.
Authors: Nick Freemantle; Yingxin Xu; Florence R Wilson; Patricia Guyot; Chieh-I Chen; Sam Keeping; Gerasimos Konidaris; Keith Chan; Andreas Kuznik; Kokuvi Atsou; Emily Glowienka; Jean-Francois Pouliot; Giuseppe Gullo; Petra Rietschel Journal: Ther Adv Med Oncol Date: 2022-06-16 Impact factor: 5.485
Authors: Iwona Kwiecień; Elżbieta Rutkowska; Małgorzata Polubiec-Kownacka; Agata Raniszewska; Piotr Rzepecki; Joanna Domagała-Kulawik Journal: Transl Lung Cancer Res Date: 2021-04