Abstract 1244P
Background
Durvalumab (DURV) is approved by the European Medicines Agency for consolidating treatment of patients with locally advanced unresectable PD-L1-expressing NSCLC after definitive RCT. Data about its real-world efficacy is limited. Patients were treated with DURV in the EAP from 22.11.2017 to 15.10.2018 (date of approval) allowing analysis of its efficacy and safety.
Methods
With consent to the EAP, patients agreed to data analysis. Participating centres were asked for submission of pseudonymized data which was analysed for progression-free survival (PFS), overall survival (OS), reasons for discontinuation, and adverse events (AE).
Results
56 centres submitted data of 126 patients who actually received at least 1 cycle DURV (60% of 211 patients enrolled in the EAP). Patients stages were IIIA (26%), IIIB (44%), IIIC (25%), IVA (4%), and IVB (2%), i. e. more advanced than in the PACIFIC trial. Most patients (96%) were former smokers (median 42 PY), and received simultaneous RCT (median dose of 65 Gy). Median FU from start of DURV was 16.8 months. 42.9% completed 12 months of planned DURV therapy. 32.5% discontinued due to progression, 9.5% due to suspected immune-related AE, and 2.4% due to other AE. Other causes were patient wish (3.6%), and denial of reimbursement after approval (4.8%). 5 patients (4.0%) discontinued due to death (progression: 2, cardiovascular cause: 1, sepsis: 1, capillary leak syndrome: 1, considered to be possibly related to DURV). Median PFS was 18.9 months, and median OS was not yet reached. The 12/18-month PFS rate was 56%/53%, the 12/18-month OS rate was 79%/75%, respectively. Squamous cell-carcinoma, advanced stage or age, male gender and use of induction chemotherapy before RCT were associated with shorter OS. PD-L1 status was known for 111 patients (0%: 32; 1-49%: 42; ≥50%: 37). There was no difference in PFS or OS between PD-L1 negative and positive patients. No unexpected AE were reported.
Conclusions
Considering the more advanced stage of the EAP patients, survival was comparable to that reported in the PACIFIC trial. PD-L1 did not predict PFS nor OS. In conclusion, consolidation treatment with DURV is manageable and safe in a real-world setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Durvalumab EAP Consortium.
Funding
Has not received any funding.
Disclosure
M. Faehling: Honoraria (self), Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy: BMS; Honoraria (self), Honoraria (institution), Advisory/Consultancy: MSD. C. Schumann: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD. P. Christopoulos: Honoraria (self), Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (self), Honoraria (institution): Takeda; Honoraria (self), Honoraria (institution): Novartis. P. Hoffknecht: Honoraria (self): AstraZeneca; Honoraria (self): Roche; Honoraria (self): Lilly; Honoraria (self): MSD. S. Eisenmann: Honoraria (self), Honoraria (institution): AstraZeneca. D. Christoph: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Takeda. All other authors have declared no conflicts of interest.