3887 - First Real Life Data on Durvalumab after definitive concomitant ChemoRadiotherapy (cCRT) in unresectable Stage (St) III Non-Small Cell Lung Cancer (NSCLC) in France: Analysis of 591 patients (pts) enrolled in the French cohort (c) Temporary Authorization of Use (ATU)

Background

Among pts with St III unresectable NSCLC, only 15% are alive at 5 years with the historical Standard of Care (SoC) of definitive cCRT. Durvalumab, a human monoclonal anti-PD-L1 antibody, demonstrated efficacy in PFS and OS and was approved in Europe on September 2018 for the treatment of St III unresectable NSCLC expressing PD-L1 ≥ 1% and without progression after CRT. ATU permits the access to innovative medicines for pts without alternatives before a market authorization is granted.

Methods

Durvalumab was administrated to pts as a 60 min intravenous infusion at 10 mg/kg every 2 weeks for a maximum of 12 months, or discontinuation due to progressive disease, Adverse Events (AE) or switch to commercial drug. Pts characteristics and safety data were prospectively collected during cATU.

Results

From March 26^th to October 28^th 2018, 188 sites requested a cATU for 591 pts with St III unresectable NSCLC who did not progress after cCRT, independently of their PD-L1 status. 561 pts were treated by Durvalumab (27 pts were treated with the commercial drug & 3 pts were lost to follow-up). 71.6% of pts were men, median age was 62.4±8.9 years. 51.7% of tumours were adenocarcinoma. 40.5% of pts were in St IIIA, 51.8% in St IIIB and 6.2% in St IIIC. All pts were treated with platinum-based cCRT, with a median dose of 66 Gy [45.0-74.0] and 54% with cisplatin-based chemotherapy. Best response to cCRT was partial response for 78.5% of pts, complete response for 6.3% and stable disease for 15.2%. By January 2019, 82.1 % of pts were still under Durvalumab and 46.3% pts treated more than 6 months. Overall, drug related AEs occurred in 17.3% of pts including 8.2% serious AEs. Most common Durvalumab related AEs (all grades) were hyperthyroidism (1.2%) and pneumonitis (1.1% or n = 6, including one death). Discontinuation occurred in 17.8% of pts, of which 5.2% were Durvalumab related.

Conclusions

These data confirm that Durvalumab has a manageable safety profile in real-life practice. Enrollment of 591 pts in 7 months highlights the high unmet need for stage III unresectable NSCLC pts and supports Durvalumab treatment as the new SoC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

V. Avrillon: Advisory / Consultancy: Bristol-Myers Squibb (BMS); Travel / Accommodation / Expenses, congress invitation: Merck Sharp & Dohme (MSD); Advisory / Consultancy: AbbVie; Advisory / Consultancy: Bristol-Myers Squibb (BMS); Advisory / Consultancy: AbbVie; Travel / Accommodation / Expenses: MSD. E. Pichon: Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS); Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Merck Sharp & Dohme (MSD). A.T. Stancu: Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS). C. Chouaid: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Clovis; Advisory / Consultancy: Glaxosmithkline; Advisory / Consultancy: Hoffmann-La Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy: Amgen. A. Lagrange: Travel / Accommodation / Expenses: Hoffmann-La Roche; Travel / Accommodation / Expenses: Takeda; Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS). M. Sabatini: Travel / Accommodation / Expenses: Sos Oxygene; Advisory / Consultancy: BMS; Travel / Accommodation / Expenses: Boehringer Ingelheim. G. Eberst: Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: boehringer ingelheim. P. Boisselier: Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: MSD; Honoraria (self): Merck Serono; Honoraria (self): BMS; Honoraria (self): Roche. All other authors have declared no conflicts of interest.