409P - IMpower010: Digital pathology (DP) vs manual SP263 PD-L1 tumour cell (TC) scoring on whole imaging slides from patients (pts) with stage II-IIIA PD-L1 TC ≥50% NSCLC

Background

PD-L1 expression is predictive of anti–PD-1/–PD-L1 therapy benefit, but intratumoural heterogeneity, interobserver variability, multiple assays and scoring systems make its reliable evaluation problematic. A clone-agnostic artificial intelligence (AI) model for AI-based measurement of PD-L1 (AIM-PD-L1) was developed to address this challenge. In this exploratory analysis, we compared manual and AIM-PD-L1 scoring of SP263-stained TC PD-L1 to assess the model’s ability to identify pts with NSCLC who can benefit from atezolizumab in an unbiased, automated manner.

Methods

IMpower010 is a global, multicenter, open-label, randomised, Phase III study of adjuvant atezolizumab vs best supportive care in pts with stage IB-IIIA NSCLC after complete resection and platinum-based chemotherapy (NCT02486718). The dataset included the stage II-IIIA biomarker-evaluable population (n=760). AIM-PD-L1 quantified PD-L1 TC expression for continuous digital scoring (range, 0–100%). Disease-free survival (DFS) at final analysis and overall survival (OS) at second interim analysis (CCOD: 26 January 2024) were used to compare DP and manual scoring. AIM-PD-L1 is for research use only and not for use in diagnostic procedures.

Results

SP263 PD-L1-positivity measured by AIM-PD-L1 at a 50% TC cutoff identified 30 additional pts (4%) with PD-L1 TC ≥50% vs manual scoring. Positive, negative and overall % agreements were 91%. Similar DFS and OS benefits were seen by DP and manual scores at 50% TC cutoffs (Table).

DFS and OS summary for PD-L1 SP263 at a 50% TC cutoff (DP vs manual scoring)

CCOD: 26 January 2024.

Conclusions

DP scoring using AIM-PD-L1 identified greater PD-L1-positive prevalence vs manual scoring at the 50% cutoff, with high analytical concordance and similar clinical benefit. This exploratory analysis demonstrates the potential of DP to be broadly and consistently applied to PD-L1 scoring and cancer immunotherapy pt selection in the clinic and for clinical trial conduct.

Clinical trial identification

NCT02486718

Editorial acknowledgement

Research support in the form of thirdparty writing assistance for this abstract, furnished by Nimisha Bhoola, PhD, of Nucleus Global, an Inizio Company,was provided by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

M. Reck: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Lilly, MSD, Merck, Novartis, Regeneron, Roche, Sanofi, GSK, Pfizer, AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Biontech, Boehringer Ingelheim, Daiichi Sankyo, Gilead, MSD, Mirati, Pfizer, Regeneron, Roche, Sanofi, GSK, Lilly; Financial Interests, Personal, Other, Member of DMSB: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Amgen, Boehringer-Ingelheim, BeiGene, Daiichi-Sankyo, GSK, BMS, Lilly, MSD, Pfizer, Seagen, Regeneron, Roche. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer, Genmab; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, BeiGene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Financial Interests, Institutional, Invited Speaker: Nuvalent; Non-Financial Interests, Personal, Leadership Role, President (2021–2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Personal, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Personal, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí N.K. Altorki: Financial Interests, Institutional, Research Grant, clinical trial: AstraZeneca. H. Wakelee: Financial Interests, Personal, Advisory Board, Served on a DSMC, completed November 2022: Mirati; Financial Interests, Personal, Invited Speaker, Develop and present a series of lectures: Fishawack Facilitate LTD; Financial Interests, Personal, Invited Speaker, Series of CME lectures: Medscape, Research to Practice; Financial Interests, Personal, Other, Discussion of new data at conferences: Curio Science; Financial Interests, Personal, Invited Speaker, Series of lectures/webinars for PER/OncLive: MJH Holdings; Financial Interests, Personal, Invited Speaker, CME lecture: Axis Medical Education, ParadigmMC, Prova Education; Financial Interests, Personal, Advisory Board: IOBiotech; Financial Interests, Personal, Invited Speaker, Facilitated speaking at several virtual conferences: Shanghai Bird Translation and Consulting; Financial Interests, Personal, Invited Speaker, Invited speaker at virtual symposium: China International Medical Foundation; Financial Interests, Personal, Invited Speaker, Invited to speak and moderate at JLCS meetings: Japanese Lung Cancer Society; Financial Interests, Personal, Invited Speaker, Presented at several CME conferences: Medical Educator Consortium; Financial Interests, Personal, Invited Speaker, Facilitated discussion of recent data: IDEOlogy Health; Financial Interests, Personal, Invited Speaker, Invited CME lecture: Vindico Medical Education; Financial Interests, Personal, Invited Speaker, Invited speaker at symposium: Taiwan Association for the Study of Lung Cancer (TASLC); Financial Interests, Personal, Royalties, I receive royalties for a chapter I wrote for UpToDate: UpToDate; Financial Interests, Institutional, Invited Speaker, Clinical Trial Conduct: AstraZeneca/Medimmune, BMS, Genentech/Roche, Merck, Seagen, Xcovery; Financial Interests, Institutional, Invited Speaker, clinical trial conduct: Helsinn; Financial Interests, Institutional, Invited Speaker, IIT for single site: Bayer; Financial Interests, Personal, Invited Speaker, uncompensated steering committee member: Merck, AstraZeneca, Genentech/Roche; Financial Interests, Personal, Other, uncompensated advisory board participation: BMS; Non-Financial Interests, Personal, Officer, Past President: International Association for the Study of Lung Cancer (IASLC); Non-Financial Interests, Personal, Leadership Role, Executive Committee: ECOG-ACRIN. E. Vallieres: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Merck. S. Oizumi: Financial Interests, Personal, Other, Honorarium: AstraZeneca, Chugai Pharmaceutical, MSD. H. Tanaka: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Boehringer Ingelheim, Eli Lilly, MSD, Ono pharmaceutical, Merck, Novartis, Takeda pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, Taiho pharmaceutical, Bristol Myers Squibb, Eisai, Hisamitsu pharmaceutical, Nippon Kayaku; Financial Interests, Institutional, Invited Speaker: Chugai pharmaceutical, Merck, AstraZeneca, MSD, Eli Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Takeda pharmaceutical, Taiho pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, AbbVie, Amgen, Janssen pharmaceutical. S. Novello: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Eli Lilly, Novartis, BeiGene, Amgen, Thermo Fisher; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen, J&J; Financial Interests, Institutional, Invited Speaker, IIT: MSD, BI; Financial Interests, Institutional, Invited Speaker: AstraZeneca, AMG, Eli Lilly, Sanofi, J&J, Roche; Non-Financial Interests, Personal, Leadership Role, president of this european advocacy: WALCE; Non-Financial Interests, Personal, Member: IASLC, AIOM, ASCO. D. Ruderman: Financial Interests, Personal, Full or part-time Employment: PathAI. B. Nabet: Financial Interests, Personal, Stocks/Shares: Roche; Financial Interests, Personal, Full or part-time Employment: Genentech Inc. L. Brunner, S. Hennek: Financial Interests, Personal, Full or part-time Employment: PathAI. B.J. Gitlitz, M. Ballinger, E. Bennett, J. Giltnane, M. Srivastava: Financial Interests, Personal, Full or part-time Employment: Genentech Inc.; Financial Interests, Personal, Stocks/Shares: Roche. C. Zhou: Financial Interests, Personal, Invited Speaker, Speaking fee, Advisory Role.: Eli Lily; Financial Interests, Personal, Invited Speaker, honoraria as a speaker.: Roche, Sanofi, Boehringer Ingelheim, MSD, C-Stone; Financial Interests, Personal, Invited Speaker, Speaking fee, advisory role.: Qilu Pharma; Financial Interests, Personal, Invited Speaker, honoraria as a speaker, advisor.: Hengrui, Innovent Biologics, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, honoraria as a speaker: Luye Pharma; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnositics; Financial Interests, Personal, Other, honoraria as a speaker: Alice; Financial Interests, Personal, Other, honoraria as a speaker from AnHeart.: AnHeart. All other authors have declared no conflicts of interest.