CHARACTERISTICS AND TREATMENT PATTERNS OF A REAL-WORLD COHORT OF PATIENTS WITH ADVANCED HER2-MUTANT NSCLC: INSIGHTS FROM THE ESME DATABASE
Author(s)
Nicolas GIRARD, MD, PhD1, Pauline Macouillard, MSc2, Heiko Zettl, PhD3, Anton Schönstein, MSc, PhD4, Lise Bosquet, MSc2, Xavier QUANTIN, MD, PhD5, Maurice Pérol, MD6.
1Institut Curie, Institut du Thorax Curie-Montsouris, Paris; Paris-Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France, 2Unicancer Health Data and Partnership Department, Paris, France, 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany, 5Institut du Cancer de Montpellier (ICM), Unicancer; IRCM, INSERM U1194, University of Montpellier, Montpellier, France, 6Centre Léon Bérard, Unicancecr, Lyon, France.
1Institut Curie, Institut du Thorax Curie-Montsouris, Paris; Paris-Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France, 2Unicancer Health Data and Partnership Department, Paris, France, 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany, 5Institut du Cancer de Montpellier (ICM), Unicancer; IRCM, INSERM U1194, University of Montpellier, Montpellier, France, 6Centre Léon Bérard, Unicancecr, Lyon, France.
OBJECTIVES: The Épidémio-Stratégie Médico-Economique lung cancer (ESME LC) database collects retrospective real-world data on French patients with lung cancer. This analysis observed characteristics and treatment regimens of patients with advanced HER2-mutant NSCLC who met main eligibility criteria of the Beamion LUNG-2 trial (NCT06151574, comparing zongertinib vs SOC as first-line treatment [1LT]).
METHODS: Data on 69,326 patients were obtained from the most recent ESME LC data cut (October 2025). Selection criteria included advanced or metastatic non-squamous NSCLC harboring a HER2 TKD mutation and ECOG status of 0/1 at 1LT. Patients were excluded if they had symptomatic brain or leptomeningeal metastases, received radiotherapy within 4 weeks of 1LT, another malignancy within 5 years of 1LT, or if their tumors carried EGFR, ALK, or ROS1 alterations.
RESULTS: The trial-like cohort comprised a total of N=140 patients. Patients were primarily female (62.1%), <65 years (52.1%), never-smokers (54.0%), with an ECOG status of 1 (55.7%). The majority of patients presented with de-novo metastatic disease (83.6%), and one third had non-symptomatic brain metastases (31.4%). Treatment regimens at 1LT mainly consisted of chemotherapy (CT) (42.9%), a combination of CT and immunotherapy (IO) (37.1%), and HER-2 directed therapies (13.6%, of whom 52.6% received T-DXd). Among CT patients, 48.3% received a carbo/cisplatin-based regimen with pemetrexed. Among CT+IO patients, 84.6% received carbo/cisplatin combined with pembrolizumab and pemetrexed. Three quarters of patients went on to receive second-line treatment (n=104), including HER2-directed therapy (39.4%, of whom 22.0% received T-DXd), CT (27.9%), and IO (17.3%). Median follow-up was 39.8 months (95%CI: 33.8-44.7).
CONCLUSIONS: In a large French real-world cohort, patients with HER2-mutant NSCLC meeting main Beamion LUNG-2 trial eligibility criteria were primarily treated with CT or a combination of CT/IO between 2015-2025. This contextual data provides insights into demographic/clinical characteristics and treatment patterns of patients with advanced HER2-mutant NSCLC, representative of clinical practice in the EU.
METHODS: Data on 69,326 patients were obtained from the most recent ESME LC data cut (October 2025). Selection criteria included advanced or metastatic non-squamous NSCLC harboring a HER2 TKD mutation and ECOG status of 0/1 at 1LT. Patients were excluded if they had symptomatic brain or leptomeningeal metastases, received radiotherapy within 4 weeks of 1LT, another malignancy within 5 years of 1LT, or if their tumors carried EGFR, ALK, or ROS1 alterations.
RESULTS: The trial-like cohort comprised a total of N=140 patients. Patients were primarily female (62.1%), <65 years (52.1%), never-smokers (54.0%), with an ECOG status of 1 (55.7%). The majority of patients presented with de-novo metastatic disease (83.6%), and one third had non-symptomatic brain metastases (31.4%). Treatment regimens at 1LT mainly consisted of chemotherapy (CT) (42.9%), a combination of CT and immunotherapy (IO) (37.1%), and HER-2 directed therapies (13.6%, of whom 52.6% received T-DXd). Among CT patients, 48.3% received a carbo/cisplatin-based regimen with pemetrexed. Among CT+IO patients, 84.6% received carbo/cisplatin combined with pembrolizumab and pemetrexed. Three quarters of patients went on to receive second-line treatment (n=104), including HER2-directed therapy (39.4%, of whom 22.0% received T-DXd), CT (27.9%), and IO (17.3%). Median follow-up was 39.8 months (95%CI: 33.8-44.7).
CONCLUSIONS: In a large French real-world cohort, patients with HER2-mutant NSCLC meeting main Beamion LUNG-2 trial eligibility criteria were primarily treated with CT or a combination of CT/IO between 2015-2025. This contextual data provides insights into demographic/clinical characteristics and treatment patterns of patients with advanced HER2-mutant NSCLC, representative of clinical practice in the EU.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH184
Topic
Epidemiology & Public Health, Health Service Delivery & Process of Care, Study Approaches
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology