1282P - Concordance of PD-L1 expression between biopsy and matched surgical specimen in early-stage non-small cell lung cancer: LC-SCRUM-Advantage/MRD

Background

Determining the Programmed death-ligand 1 (PD-L1) expression status may help identify patients who will benefit from immune checkpoint inhibitor in perioperative treatment for early-stage non-small cell lung cancer (NSCLC). We evaluate the concordance of PD-L1 expression between biopsies and matched surgical specimens as part of a multicenter prospective genomic screening study in LC-SCRUM-Advantage/MRD.

Methods

Patients with preoperative untreated resectable clinical stage I to III NSCLC were eligible for this study. PD-L1 Tumor Proportion Score (TPS) was assessed in patients with operable NSCLC on both lung biopsies before surgery and matched surgical specimens after surgery, by using a 22C-3 Immunohistochemistry assay.

Results

Between August 2022 and April 2023, a total of 181 patients were enrolled in LC-SCRUM-Advantage/MRD. Of 62 evaluable patients at this analysis, 33(53%)/17(28%)/12(19%) had stage I/II/IIIA disease and 46 (74%) had adenocarcinoma histology, 54 (85%) were diagnosed by bronchoscopic biopsy before surgery. The success rate of PD-L1 TPS analysis in biopsy specimens was 98%, and median turnaround time was 7 days (quartile range, 3-13). In biopsy specimens, PD-L1 TPS was observed in 34 (56%), 17 (28%), and 9 (16%) cases for the cutoff values <1%, 1-49%, and ≥50%, respectively. On the other hand, all surgical specimens were successfully analyzed, PD-L1 TPS was observed in 22 (48%), 15 (32%), and 9 (20%) cases for the cutoff values <1%, 1-49%, and ≥50%, respectively. The overall concordance rate of PD-L1 TPS between biopsy specimen and matched surgical specimen was 74% (35/47). The concordance rate at a cut-off value of <1%/1-49%/≥50% PD-L1 TPS were 91% (20/22), 53% (8/15), and 67% (6/9). The breakdown of discordant in PD-L1 TPS 1-49% between biopsy and matched surgical specimens, 86% (6/7) was TPS <1% in biopsy specimens.

Conclusions

PD-L1 TPS demonstrated a high concordant rate between biopsy and matched surgical specimens in patients with early-stage NSCLC. However, PD-L1 TPS 1-49% concordance rate is relatively low and may be underestimated, especially in biopsy specimens.

Clinical trial identification

UMIN000048977.

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Center.

Funding

National Cancer Center Research and Development Fund 28-A-6.

Disclosure

Y. Zenke: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly, Chugai, Boehringer Ingelheim, Ono Pharmaceutical, Bristol Myers Squibb, Takeda Pharmaceutical, Taiho Pharmaceutical, MSD, Novartis, Nippon-Kayaku, Amgen, Kyowa-Hakko Kirin; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, MSD, Merck, Daiichi Sankyo, Amgen. K. Yoh: Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Lilly, Boehringer Ingelheim, Amgen, Takeda; Financial Interests, Institutional, Local PI: AstraZeneca, Lilly, Daiichi Sankyo, AbbVie, Taiho, MSD, Takeda, Amgen, Boehringer Ingelheim, Chugai; Financial Interests, Personal, Steering Committee Member: AstraZeneca. J. Samejima: Financial Interests, Personal, Writing Engagement: Taiho Pharmaceutical Co., Ltd, Shizenkagakusha, Stryker, Ziosoft; Financial Interests, Personal, Invited Speaker: B Braun, Ziosoft, Johnson & Johnson, MiRXES, Taiho Pharmaceutical Co., Ltd; Financial Interests, Personal, Other, Providing surgical videos: Olympus, Johnson & Johnson. H. Daga: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, AstraZeneca. K. Kunimasa: Financial Interests, Institutional, Funding: Taiho, AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Eli Lilly, Roche Diagnostics, Daiichi Sankyo, Novartis, Pfizer, Merck, Bristol Myers Squibb, Nippon Kayaku. I. Nakachi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, Novartis Pharma. A. Osoegawa: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Ono Pharmaceutical, AstraZeneca, Chugai Pharmaceutical, MSD. H. Izumi: Financial Interests, Institutional, Local PI: Amgen Inc, Eisai, AbbVie; Financial Interests, Personal and Institutional, Local PI, Invited Speaker: Ono Pharmaceutical Company, AstraZeneca; Financial Interests, Personal, Other, Invited Speaker: Chugai Pharmaceutical Co., Merck Biopharma Co., Takeda Pharmaceutical Co.; Financial Interests, Personal, Other, Advisory board: Amgen. T. Sakai: Financial Interests, Institutional, Funding: Amgen, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Novartis, MSD, Thermo Fisher Scientific, Merck. S. Umemura: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical. S. Matsumoto: Financial Interests, Personal, Invited Speaker: Merck Biopharma, Eli Lilly, AstraZeneca, Chugai, Novartis, Guardant Health, Amgen, Takeda; Financial Interests, Institutional, Local PI: Merck Biopharma, Janssen Pharmaceutical K.K., MSD. M. Tsuboi: Financial Interests, Personal, Invited Speaker, Lecture: Johnson & Johnson Japan; Financial Interests, Personal, Advisory Board, Lectures, Advisory boards: AstraZeneca KK, Chugai Pharmaceutical Co.,Ltd, MSD; Financial Interests, Personal, Invited Speaker, Lectures: Eli Lilly Japan, Bristol Myers Squibb KK, Taiho Pharma, Medtronic Japan, Ono Pharmaceutical Co.,Ltd; Financial Interests, Personal, Advisory Board, Advisory boards: Novartis; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo company limited; Financial Interests, Institutional, Research Grant: Beohringer-Ingelheim Japan, MSD, AstraZeneca KK, Ono Pharmaceutical Co.,Ltd, Bristol Myers Squibb KK, Novartis, MiRXES; Financial Interests, Personal, Steering Committee Member: MSD, AstraZeneca, Novartis; Financial Interests, Institutional, Steering Committee Member: Eli Lilly Japan. K. Goto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Amgen K.K., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Inc., Amoy Diagnosties Co.,Ltd., AstraZeneca K.K., Bayer HealthCare Pharmaceuticals Inc., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb K.K., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Guardant Health Inc., Merck Biopharma Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Thermo Fisher Scientific K.K., Taiho Pharmaceutical Co., Ltd., Syneos Health Clinical K.K., Life Technologies Japan Ltd.; Financial Interests, Personal, Advisory Board: Janssen Pharmaceutical K.K., Medpace Japan K.K., Haihe Biopharma Co., Ltd.; Financial Interests, Personal and Institutional, Funding: Amgen Inc., Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Haihe Biopharma Co., Ltd., Ignyta,Inc., Janssen Pharmaceutical K.K., Kissei Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Loxo Oncology, Inc., Medical & Biological Laboratories Co., Ltd., Merus N.V., MSD K.K., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sysmex Corporation., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Turning Point Therapeutics,Inc., Amgen Astellas BioPharma K.K., Bayer Yakuhin, Ltd., Blueprint Medicines Corporation., Life Technologies Japan Ltd., NEC Corporation., Novartis Pharma K.K., Craif Inc., Pfizer R&D Japan G.K., Turning Point Therapeutics,Inc.; Non-Financial Interests, Member: American Society of Clinical Oncology, The Japan Lung Cancer Society, Japanese Society of Medical Oncology, The Japanese Cancer Association. All other authors have declared no conflicts of interest.