Abstract 311P
Background
Small-cell lung cancer (SCLC) is an aggressive form of lung cancer associated with poor prognosis. In 2020, durvalumab (D) combined with platinum-etoposide (PE) was approved for extensive-stage (ES) SCLC based on efficacy demonstrated in the CASPIAN trial. The ARSENAL study aims to complement those results with real-world (rw) evidence on the effectiveness and use of D in ES-SCLC.
Methods
This prospective, observational study was conducted in 33 sites in France in patients (pts) newly treated with D plus PE for ES-SCLC between Nov 2022 and Feb 2024. Pts were regularly followed up at D0 (first infusion of D and/or PE),weeks 6 and 12 and subsequently every 2 to 3 months. Primary and secondary outcomes were Time To Discontinuation (TTD) and rw Progression Free Survival (PFS).
Results
232 pts initiated D, of whom 213 were included in the interim analysis with a median follow up of 10.4 months (mo) (IQR 6.6–13.9). At baseline, pts had a median age of 69 years (IQR 62–74), with 67.1% aged ≥65 years. 63.8% were male and 97.8% were current or former smokers. The ECOG PS distribution was 16.6%, 61.3%, 18.6%, and 3.5% for PS 0, 1, 2, and 3, respectively. The main metastatic sites were liver (48%), bone (41%), and brain (21%). D was combined with E and carboplatin in 98.1% of pts, with only 1.9% (n=4) receiving cisplatin. The treatment included a median of 4 induction cycles (D+PE), and a median of 2 maintenance cycles (D alone). Overall, 121 pts (58.2%) discontinued D, primarily due to progression (59.5%), death (14.9%), or adverse events (AEs) (9.1%). The median TTD was estimated at 5.6 months (95% CI 4.9–6.0), with a 6-mo TTD rate of 40.6% (95% CI 32.6–48.5). Median PFS was 5.1 months (95% CI 4.6–6.2), with a 6-mo PFS rate of 45.4% (95% CI 37.5–53.3). Treatment-related grade ≥3 AEs were reported in 27 (11.6%) pts with anemia and thrombocytopenia being the most frequent.
Conclusions
The effectiveness results of this first interim analysis from ARSENAL rw study are consistent with CASPIAN study (median PFS was 5.1 months in the D arm), although the study population was older and frailer. ARSENAL is, to our knowledge, the rw study in ES-SCLC pts treated with durvalumab and platinum-based chemotherapy with the highest prevalence of PS2+ pts.
Clinical trial identification
NCT05683977.
Editorial acknowledgement
The authors also thank Kappa Santé for the project management, monitoring, data management, statistics and medical writing assistance.
Legal entity responsible for the study
AstraZeneca France.
Funding
AstraZeneca France.
Disclosure
C. Decroisette: Financial Interests, Personal, Advisory Board: BMS, MSD, Roche, Takeda, Pfizer, Sanofi, AstraZeneca, Amgen, Janssen, Novartis, Danone, Novocure, Regeneron; Financial Interests, Personal, Invited Speaker: MSD, Amgen, Pfizer, Regeneron, Takeda. J.B. Auliac: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Hoffman-Roche, Takeda, BMS, MSD, Sanofi, AstraZeneca, Amgen, Janssen, Pfizer. C. Chouaid: Financial Interests, Personal, Research Grant: AbbVie, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, BMS, Daiichi Sankyo, Gilead, F. Hoffmann-La Roche, Janssen, LeoPharma, Lilly, Merk Serono, MSD, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, BeiGene, BMS, Daiichi Sankyo, Gilead, Ipsen, F. Hoffmann-La Roche, Janssen, LeoPharma, Lilly, MSD, Novocure, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi, Takeda. F. Guisier: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Janssen, MSD, Pfizer, Roche, Sanofi, Takeda, Viatris; Financial Interests, Personal, Research Grant: Janssen, Roche, Takeda. A. Vergnenegre: Financial Interests, Personal, Advisory Role: Pierre Fabre, Amgen, MSD; Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, Sanofi, Amgen, Pierre Fabre. V. Leroy: Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, Roche. C. Addi, N. Goyard, A. Lahouegue, F. Marlin, L. Mounier: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. L. Falchero: Financial Interests, Personal, Advisory Board: MSD, BMS, AstraZeneca, Roche, Amgen, Takeda.