Found 1 Presentation For Request "1476p"
1476P - Outcomes to first-line pembrolizumab in patients with advanced NSCLC and high PD-L1 expression: A Spanish multicentric study
- Aida Piedra (Barcelona, Spain)
Abstract
Background
Pembrolizumab stands as a first-line option for patients (p) with advanced NSCLC and high PD-L1 expression (≥50%). Several factors influenced outcomes such as antibiotic (AB) exposure, low body mass index (BMI), certain metastasic location (e.g. bone), or ECOG-PS of 2.
Methods
We performed a multicenter retrospective study in 8 Spanish hospitals to evaluate clinical outcomes according to several factors in patients with stage IV high PD-L1 expression NSCLC treated with first-line pembrolizumab in clinical practice. We included data from patients treated between May 2017 and July 2022.
Results
Among the 494 patients, median age was 67.2 years (29.4-89.43), 379p (76.7%) were male, 138p (27.9%) had an ECOG PS of 0, 269p (54.5%) had an ECOG PS of 1, 87p (17.6%) had an ECOG of ≥2 and 230p (46.6%) had a BMI of <24.9. 158p (32.0%) had bone metastases. 175p (35.5%) had antibiotic (AB) exposure during treatment with pembrolizumab or 4 weeks before initiation, and 210p (42.5%) underwent treatment with corticosteroids during treatment with pembrolizumab or 4 weeks before initiation [>10mg prednisone equivalent (>10mg PDNe)]. 308p (62.3%) had proton pump inhibitors (PPi) exposure. With a median follow-up of 12.6 months (m), the median overall survival (OS) and the progression-free-survival (PFS) were 16.9m (95% CI 12.9-19.2) and 9.9m (95% CI 7.7-12.1), respectively, and the overall response rate (ORR) was 43.3%. Multiple variables were associated with survival after univariate analysis (Table). After multivariate analysis, corticosteroid treatment (HR 1.41) and ECOG (HR 2.40) maintained a prognostic impact: poor PS (ECOG ≥2) and having been exposed to corticosteroids were predictive of poor outcome.
Median OS - months (95% CI) p-value (univariate analysis) 0 (N=138) 36.7 (20.3-53.2) 1 (N=269) 14.8 (11.7-17.9) 2 (N=81) 2.7 (1.8-3.7) 3 (N=6) 0.3 (0.03-0.2) < 0.001 No (N=284) 22.3 (17.9-26.7) Yes (N=210) 11.4 (8.0-14.7) < 0.001 irAEs (N=57) NR Baseline conditions/symptom management (N=153) 4.8 (1.4-8.3) < 0.001 No (N=186) 23.0 (18.1-28.0) Yes (N=308) 12.6 (9.5-15.7) 0.002 No (N=336) 20.2 (16.6-23.8) Yes (N=158) 9.3m (4.9-13.7) 0.001 CR (N=30) NR PR (N=184) NR SD (N=113) 15.7 (13.8-17.8) PD (N=117) 4.0 (3.1-5.0) Not evaluated (N=50) 0.8 (0.6-1.0) <0.001
Conclusions
First-line pembrolizumab in advanced NSCLC patients with high PD-L1 expression should only be used in patients with good PS. Patients with PS 2 are in urgent need of new treatment approaches.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Arriola: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Lilly; Financial Interests, Personal, Invited Speaker: Takeda, MSD, AstraZeneca, BMS, Thermo Fisher Scientific, Guardant Health, Pfizer; Financial Interests, Personal, Other, Co-founder: Trialing Health; Financial Interests, Institutional, Research Grant: AstraZeneca. A. Calles Blanco: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Pfizer, Roche, Lilly, Merck Sharp & Dohme, Novartis, Bristol Myers Squibb, Takeda, Sanofi, Janssen; Financial Interests, Personal, Other, Speaker honoraria: Bayer; Financial Interests, Institutional, Research Grant, Drug-only for Investigator-initiated trial.: Merck Sharp & Dohme. R.M. Alvarez: Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Advisory Board: Boehringer, Novartis, Roche; Financial Interests, Personal, Other, conference registration: MSD Oncology; Financial Interests, Institutional, Coordinating PI: Roche; Financial Interests, Personal and Institutional, Coordinating PI: Janssen Oncology, Rain Therapeutics, Boehringer, Cebiotex, Novartis. I.G. Sullivan: Financial Interests, Personal, Advisory Board: Roche, Novartis, Boehringer Ingelheim, Takeda, Sanofi, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Takeda, Pfizer, Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel grant: Roche, Takeda, Lilly, AstraZeneca. 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; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, 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, Local PI, 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; Non-Financial Interests, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Cassen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. All other authors have declared no conflicts of interest.