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R. Salanova



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    PD-L1 expression and tumor microenvironment in advanced lung cancer (ID 59)

    • Event: ELCC 2018
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
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      130O - Real-world prevalence of PD-L1 expression in locally advanced or metastatic non-small cell lung cancer (NSCLC): The global, multicentre EXPRESS study (ID 619)

      16:45 - 18:15  |  Author(s): R. Salanova

      • Abstract
      • Presentation
      • Slides

      Background:
      PD-L1 expression on tumour cells has been associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicentre, retrospective observational study to determine real-world prevalence of tumour PD-L1 expression in patients with advanced NSCLC.

      Methods:
      Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumour tissue block (≤5 years old) obtained before treatment at or after this stage were identified in 45 centres across 18 countries. PD-L1 tumour expression was evaluated at each institution using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA). The percentages of patients with PD-L1 tumour proportion score (TPS) ≥50%, TPS ≥1%, and TPS <1% were described overall and by relevant clinicopathologic characteristics.

      Results:
      Of 2634 patients who met inclusion criteria, 2435 (92%) had PD-L1 data; 540 (22%) of these were TPS ≥50%, 1256 (52%) were TPS ≥1%, and 1179 (48%) were TPS <1% (Table). The percentage of patients with PD-L1 TPS ≥50% and TPS ≥1%, respectively were: 22%/51% in Europe; 22%/53% in Asia Pacific; 22%/47% in the Americas, and 24%/54% in other countries. The prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports in metastatic NSCLC. Among 1088 patients negative for both EGFR mutation and ALK alteration, the percentage of patients with PD-L1 TPS ≥50% and TPS ≥1%, respectively, were 26% and 53%.

      Characteristic, n (%)[a]NTPS ≥50%TPS ≥1%TPS <1%
      All patients2435540 (22.2)1256 (51.6)1179 (48.4)
      Age, years
       ≥75457107 (23.4)227 (49.7)230 (50.3)
       <751977433 (21.9)1029 (52.0)948 (48.0)
      Sex
       Female925191 (20.6)477 (51.6)448 (48.4)
       Male1509348 (23.1)778 (51.6)731 (48.4)
      Region
       Asia Pacific691152 (22.0)366 (53.0)325 (47.0)
       Europe849183 (21.6)431 (50.8)418 (49.2)
       The Americas[b]36980 (21.7)175 (47.4)194 (52.6)
       Other[c]526125 (23.8)284 (54.0)242 (46.0)
      Specimen type
       Surgical resection618127 (20.6)330 (53.4)288 (46.6)
       Biopsy1743400 (22.9)895 (51.3)848 (48.7)
      Specimen source
       Primary1735377 (21.7)892 (51.4)843 (48.6)
       Metastases632143 (22.6)321 (50.8)311 (49.2)
      Histology
       Squamous507114 (22.5)288 (56.8)219 (43.2)
       Nonsquamous1906420 (22.0)956 (50.2)950 (49.8)
      Smoking status
       Never553100 (18.1)255 (46.1)298 (53.9)
       Former660159 (24.1)358 (54.2)302 (45.8)
       Current762187 (24.5)401 (52.6)361 (47.4)
      ALK translocation status
       Positive7715 (19.5)50 (64.9)27 (35.1)
       Negative1470352 (23.9)765 (52.0)705 (48.0)
      EGFR mutation status
       Positive46460 (12.9)200 (43.1)264 (56.9)
       Negative1286324 (25.2)682 (53.0)604 (47.0)
      aThe number of patients with the specific characteristic (row total) is the denominator for percentages in TPS columns.bIncludes Argentina, Canada, and Colombia.cIncludes Russian Federation, Saudi Arabia, and Turkey.

      Conclusions:
      This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumour expression using the 22C3 pharmDx kit. Testing failure rate was low despite local evaluation of PD-L1 TPS across a large number of sites. Prevalence of PD-L1 TPS ≥50% and TPS ≥1% was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations (Aggarwal et al. Ann Oncol 2016;27:1060P).

      Clinical trial identification:


      Legal entity responsible for the study:
      Merck & Co., Inc., Kenilworth, NJ, USA

      Funding:
      This study and medical writing assistance were funded by Merck & Co., Inc., Kenilworth, NJ, USA.

      Disclosure:
      G. Bigras: Advisory board member for Merck. T. Hida: Grants and personal fees from AstraZeneca, Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly, Novartis, Taiho Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim, Pfizer, Bristol-Meyers Squibb, Clovis Oncology, MSD, and Kissei; grants from Eisai, Takeda Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma, Abbvie, Merck Serono, Kyowa Hakko Kirin, Daiichi Sankyo, Astellas, Ignyta, and Servier. B. Piperdi, T. Burke, S. Khambata-Ford, A. Deitz: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. All other authors have declared no conflicts of interest.

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