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P. Micke
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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
- Now Available
- Moderators:G. Scagliotti, F. Skoulidis
- Coordinates: 4/12/2018, 16:45 - 18:15, Room B
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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 (Now Available) (ID 619)
17:00 - 17:15 | Author(s): P. Micke
- Abstract
- Presentation
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%.
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.Characteristic, n (%)[a] N TPS ≥50% TPS ≥1% TPS <1% All patients 2435 540 (22.2) 1256 (51.6) 1179 (48.4) Age, years ≥75 457 107 (23.4) 227 (49.7) 230 (50.3) <75 1977 433 (21.9) 1029 (52.0) 948 (48.0) Sex Female 925 191 (20.6) 477 (51.6) 448 (48.4) Male 1509 348 (23.1) 778 (51.6) 731 (48.4) Region Asia Pacific 691 152 (22.0) 366 (53.0) 325 (47.0) Europe 849 183 (21.6) 431 (50.8) 418 (49.2) The Americas[b] 369 80 (21.7) 175 (47.4) 194 (52.6) Other[c] 526 125 (23.8) 284 (54.0) 242 (46.0) Specimen type Surgical resection 618 127 (20.6) 330 (53.4) 288 (46.6) Biopsy 1743 400 (22.9) 895 (51.3) 848 (48.7) Specimen source Primary 1735 377 (21.7) 892 (51.4) 843 (48.6) Metastases 632 143 (22.6) 321 (50.8) 311 (49.2) Histology Squamous 507 114 (22.5) 288 (56.8) 219 (43.2) Nonsquamous 1906 420 (22.0) 956 (50.2) 950 (49.8) Smoking status Never 553 100 (18.1) 255 (46.1) 298 (53.9) Former 660 159 (24.1) 358 (54.2) 302 (45.8) Current 762 187 (24.5) 401 (52.6) 361 (47.4) ALK translocation status Positive 77 15 (19.5) 50 (64.9) 27 (35.1) Negative 1470 352 (23.9) 765 (52.0) 705 (48.0) EGFR mutation status Positive 464 60 (12.9) 200 (43.1) 264 (56.9) Negative 1286 324 (25.2) 682 (53.0) 604 (47.0)
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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