Abstract 1491P
Background
The optimal duration of immune checkpoint inhibitors (ICI) in metastatic non-small cell lung cancer (NSCLC) remains uncertain. Some physicians administer ICI for 2 years then discontinue it according to the designs of clinical trials, while other physicians continue ICI until progression. This study aims to explore the clinical course after discontinuation of ICI and identify factors related with durable responses after ICI cessation.
Methods
We retrospectively analyzed 45 patients with metastatic NSCLC who received ICI for ≥1.5 years and then discontinued treatment. All patients showed complete response or partial response or stable disease. Patients who initiated ICI between Jan 2014 and Dec 2020 were enrolled. Clinical factors including PD-L1 status were analyzed.
Results
The median duration of ICI treatment was 23.4 months, and the median follow-up duration from ICI discontinuation was 14.1 months. Thirty-five patients (77.7%) showed durable response after ICI cessation which lasted for median 17.0 months without any treatment, while 10 patients showed disease progression. Durable response was significantly associated with PD-L1 TPS ≥50% (28/31, OR 0.12, 95% CI 0.01-0.80, p=0.013). PD-L1 TPS ≥50% was significantly associated with longer PFS (median not reached vs. 41.9 months, HR 0.16, 95% CI 0.04-0.68, p=0.005). In multivariate analysis, only PD-L1 TPS ≥50% was an independent predictor of longer PFS after ICI discontinuation (HR 0.17, 95% CI 0.04-0.71, p=0.015). Table: 1491P
Baseline characteristics
Durable response (n=35) | Disease progression (n=10) | P value | |
Male | 32 (91.4%) | 9 (90.0%) | 1.000 |
Age | 67 (37-79) | 65 (59-78) | 0.714 |
PD-L1 TPS | 90% (0-100) | 15% (0-100) | 0.005* |
≥1% | 30 (90.9%) | 6 (75.0%) | 0.528 |
≥50% | 28 (84.8%) | 3 (37.5%) | 0.019* |
ICI agent | 1.000 | ||
Pembrolizumab | 21 (60.0%) | 3 (30.0%) | |
Nivolumab | 10 (28.6%) | 6 (60.0%) | |
Others | 4 (11.4%) | 1 (10.0%) | |
ICI line | 0.124 | ||
1 | 15 (42.9%) | 1 (10.0%) | |
≥2 | 20 (57.1%) | 9 (90.0%) |
Conclusions
PD-L1 TPS ≥50% predicts durable response without any treatment after ICI discontinuation in metastatic NSCLC patients treated with ≥1.5 years of ICI. Further biomarker research is required to identify which patients should continue receiving ICI and which can be tried with ICI cessation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
B. Keam: Financial Interests, Personal, Invited Speaker: Merck, Lily; Financial Interests, Personal, Advisory Board: Handok, Trial Informatics, Immun Oncia, NeoImmuneTech, BeiGene; Financial Interests, Personal, Coordinating PI: MSD Oncology, AstraZeneca, Ono Pharmaceutical. J. Youk: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis. M. Kim: Financial Interests, Personal, Advisory Board: Ipsen, Bristol Myers Squibb/Ono Pharmaceutical, Eisai, Yuhan, MSD, Pfizer; Financial Interests, Personal, Invited Speaker: Novartis, Astellas, MSD. T.M. Kim: Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen, Novartis, Takeda, Samsung Bioepis, Regeneron; Financial Interests, Personal, Research Grant: AstraZeneca-KHIDI; Non-Financial Interests, Principal Investigator: AstraZeneca/MedImmune, Boryung, Hanmi, Janssen, Boehringer Ingelheim, Novartis, Takeda, Sanofi, Roche/Genentech, Merck Sharp & Dohme Corp, Merck Serono, Regeneron, Genmab, Bayer, Rapt Therapeutics, Blueprint Medicines Corporation, Black Diamond Therapeutics, AbbVie, Amgen, Beyondbio Inc, Fore Biotherapeutics, Dizal Pharmaceutical, Incyte Corporation. D. Kim: Financial Interests, Personal, Invited Speaker: Korean Cancer Association, Korean Society of Medical Oncology, Korean Association for Lung Cancer, Taiwan Lung Cancer Society, Japan Cancer Association; Financial Interests, Personal, Other, Scientific Advisor: Health Insurance Review & Assessment Service, Korea; Financial Interests, Personal, Writing Engagement, Medical writing assistance: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Chong Keun Dang, Daiichi Sankyo, GSK, Novartis, Pfizer, MSD, Merck, Roche, Takeda, Yuhan; Financial Interests, Institutional, Local PI, Clinical Trial Funding: Hanmi, Alpha Biopharma, Amgen, AstraZeneca/Medimmune, Boehringer Ingelheim, Daiichi Sankyo, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan, Bridge BioTherapeutics, GSK; Financial Interests, Institutional, Coordinating PI, Clinical Trial Funding: Chong Keun Dang; Financial Interests, Institutional, Research Grant, Laboratory research funding to my institution: InnoN; Non-Financial Interests, Advisory Role: Amgen, BMS / Ono Pharmaceuticals, Daiichi Sankyo, Janssen, GSK, Pfizer, AstraZeneca, SK Biopharm, Takeda, Yuhan; Non-Financial Interests, Member of Board of Directors: Korean Cancer Association, Korean Society of Medical Oncology, Korean Association for Lung Cancer, Asian Thoracic Oncology Research Group; Other, Travel support for advisory board meeting attendance: Amgen, Daiichi Sankyo; Other, Clinical trial research funding to my institution: Asian Thoracic Oncology Research Group. All other authors have declared no conflicts of interest.
Resources from the same session
1554P - Clinical Impact of ERBB2 copy number and tumor mutation burden (TMB) in patients with HER2- positive advanced gastric cancer treated by nivolumab (N-mab) plus trastuzumab (T-mab) and standard chemotherapy
Presenter: Hirokazu Shoji
Session: Poster session 21
1555P - Cell-free DNA analysis in patients with metastatic gastroesophageal adenocarcinoma: Preliminary results of the REGIRI - PRODIGE 58 ancillary study
Presenter: Alexandre Harlé
Session: Poster session 21
1556P - Pharmacokinetics, pharmacodynamics and exposure response analyses of osemitamab in patients with locally advanced or metastatic solid tumors
Presenter: Lin Shen
Session: Poster session 21
1557P - Single-cell RNA-seq dissecting the initiating liver metastasis cells and liver metastatic microenvironment in gastric cancer
Presenter: Shu-yue Zheng
Session: Poster session 21
1558P - Preoperative pembrolizumab plus chemotherapy for resectable esophageal squamous cell carcinoma (ESCC): The phase II Keystone-001 trial
Presenter: hongjing jiang
Session: Poster session 21
1559P - PD-L1 expression as a negative predictive biomarker in advanced esophageal squamous cell cancer treated with chemotherapy alone: A KMSubtraction derived analysis
Presenter: Manavi Sachdeva
Session: Poster session 21
1560P - Osemitamab (TST001): An ADCC enhanced humanized anti-CLDN18.2 mab, demonstrated improved efficacy in combination with anti-PD-L1/PD-1 mab and oxaliplatin/5-FU in preclinical tumor models
Presenter: Xueming Qian
Session: Poster session 21
1561P - APC mutation (mt.), MYC, and GATA6 amplifications (amp.) were associated with worse survival in HER2-positive advanced gastric cancer patients treated with S-1/capecitabine plus oxaliplatin combined with trastuzumab (T-mab) and nivolumab (N-mab)
Presenter: Takeru Wakatsuki
Session: Poster session 21
1562P - Claudin 18.2 expression in resected gastric cancer
Presenter: Mitsuhiro Furuta
Session: Poster session 21
1563P - Tumor-intrinsic subtypes of esophageal adenocarcinoma associate cellular phenotypes with responses to therapy
Presenter: Dionne Blangé
Session: Poster session 21