Abstract 3887
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 26th to October 28th 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.
Resources from the same session
4294 - The Patient Voice: An Irish Survey of Nutrition Attitudes & Access to Dietetic Care Throughout the Cancer Journey
Presenter: Erin Stella Sullivan
Session: Poster Display session 1
Resources:
Abstract
1925 - Homcology: home chemotherapy delivery in a simultaneous care project for frail advanced cancer patients
Presenter: Claudio Chini
Session: Poster Display session 1
Resources:
Abstract
4701 - Treatment-related adverse events and tolerability in patients with advanced non-squamous non-small cell lung cancer treated with first-line checkpoint inhibitors in combination with chemotherapy
Presenter: Ruth D'cunha
Session: Poster Display session 1
Resources:
Abstract
2985 - Clinical utility of a systematic toxicity assessment form (STAF) in patients with breast cancer receiving adjuvant or neoadjuvant therapy.
Presenter: Jwa Hoon Kim
Session: Poster Display session 1
Resources:
Abstract
2358 - Physicians’ satisfaction with Health-related quality of life (HRQoL) assessment in daily clinical practice using electronic patient-reported outcome (ePRO) for cancer patients.
Presenter: Guillaume Mouillet
Session: Poster Display session 1
Resources:
Abstract
5172 - Predictors of Survival in Patients with Incurable Cancer
Presenter: Erin Stella Sullivan
Session: Poster Display session 1
Resources:
Abstract
2281 - Patients and Physicians' Satisfaction with Telemedicine (TM) in Cancer Care and Factors that Correlate with a Positive Patient’s Experience
Presenter: Hurria Gondal
Session: Poster Display session 1
Resources:
Abstract
2193 - Adherence to ESMO 2014 guidelines on bone-targeting agent (BTA) initiation for breast and prostate cancer patients: real-world insights from practicing European physicians
Presenter: Alex Rider
Session: Poster Display session 1
Resources:
Abstract
2200 - Use of skeletal-related events preventive agents in patients with solid tumours and bone metastases in central Denmark
Presenter: Anders Boysen
Session: Poster Display session 1
Resources:
Abstract
2504 - Inadequacy of current definition and staging system of Medication-Related Osteonecrosis of Jaw (MRONJ) released by AAOMS : a Computed Tomography study in 151 cancer and myeloma patients
Presenter: Vittorio Fusco
Session: Poster Display session 1
Resources:
Abstract