Abstract 1242P
Background
Based on the positive results of the PACIFIC trial, AstraZeneca opened an early access program (EAP) to provide durvalumab to unresectable stage III non-small cell lung cancer (NSCLC) patients with a performance status≤2, who have not progressed after treatment with concurrent or sequential chemoradiation therapy (CRT), regardless of tumor PD-L1 expression.
Methods
Pacific Real World (Pacific R) is an observational cohort study of patients who have received at least one dose of durvalumab as part of the EAP between September 2017 and December 2018. Data are collected from routine clinical care by chart abstractions at specified intervals up to five years after the patient was enrolled in the EAP. This study will enroll up to 1200 patients from France, Germany, Italy, Spain, the UK, the Netherlands, Norway, Belgium, Switzerland, Israel and Australia. A preliminary description of the first 615 patients is presented here.
Results
At time of this analysis, all countries except the UK and Spain have enrolled patients. The cohort was mostly male (67.7%) with a mean age of 64.1 years; 28.4% were ≥70 years. Nearly all patients (91.7%) had a history of smoking. Hypertension (28.6%) and COPD (25.5%) were the most frequently reported comorbidities. PDL-1 and EGFR testing were reported for 67.5% and 44% of participants, respectively. Patients had an initial diagnosis of stage III (43.4% IIIA, 45.3% IIIB, 6.9% IIIC). Adenocarcinoma (56.9%) and squamous (33.4%) were the most common histologies. Cisplatin/vinorelbine and carboplatin/paclitaxel were the most commonly administered chemotherapies prior to durvalumab. The average duration and total dose of radiotherapy was 6.95 weeks and 62.9 Gray. Most (85%) of Pacific R patients received concurrent CRT. Further CRT details, PDL1/EGFR rate will be in the poster.
Conclusions
This preliminary analysis of a stage III unresectable NSCLC cohort provides insight into makeup of the Pacific R cohort. Future analyses will focus on progression-free survival, overall survival, duration of durvalumab and adverse events of special interest (e.g. pneumonitis, interstitial lung disease).
Clinical trial identification
D4194R00005.
Editorial acknowledgement
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZenca.
Disclosure
N. Girard: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD. R. Fietkau: Honoraria (self), Research grant/Funding (institution): Merck Serono; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Novocure; Honoraria (self): Brainlab; Honoraria (self): Fresenius Kabi; Honoraria (self): Bristol-Myers Squibb. M. Garassino: Leadership role, Research grant/Funding (institution), PI, MISP in Thimic malignancies: Eli Lilly; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Local PI, Enrollment in clinical Trials in NSCLC: Otsuka Pharma; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment and Steering Committee in clinical Trials in NSCLC: AstraZeneca; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: Novartis; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: Bristol-Myers Squibb; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: Roche; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, MISP in Thimic malignancies: Pfizer; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: Celgene; Honoraria (self): Incyte; Honoraria (self): Inivata; Honoraria (self): Takeda; Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinical Trials Thimic malignancies: Tiziana Sciences; Leadership role, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Clovis; Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: Merck Serono; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in Mesothelioma: Bayer; Honoraria (self), Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials in NSCLC: MSD; Leadership role, Research grant/Funding (institution), Local PI, Enrollment and Steering committee in clinical Trials in NSCLC: GlaxoSmithKline S.p.A. ; Honoraria (self): Sanofi-Aventis; Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials: Spectrum Pharmaceutcials; Leadership role, Research grant/Funding (institution), PI, Enrollment in clinical Trials : Blueprint Medicine; Honoraria (self): Seattle Genetics; Honoraria (self): Daiichi Sankyo; Honoraria (self): Bayer Healthcare Pharmaceuticals; Honoraria (self): Janssen; Honoraria (self): GlaxoSmithKline. P. Garrido: Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy: Blue-Print Medicines; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Speaker Bureau/Expert testimony: Gilead; Speaker Bureau/Expert testimony: Rovi. J.K. Field: Honoraria (institution): AstraZeneca. S. Peters: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Investigation in Trials: Amgen; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Investigation in Trials: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Biocartis; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Investigation in Trials: Clovis; Honoraria (self), Advisory/Consultancy: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy: Debiopharm; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, Investigation in Trials: F. Hoffmann-La Roche; Honoraria (self), Advisory/Consultancy: Foundation Medicine; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Investigation in Trials: Illumina; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, Investigation in Trials: Merck Sharp & Dohme Corp., Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Investigation in Trials: Merck Serono; Honoraria (self), Advisory/Consultancy: Merrimack; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, Investigation in Trials: Novartis; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, Investigation in Trials: Pfizer; Honoraria (self), Advisory/Consultancy: Regeneron; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Investigation in Trials: Sanofi; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Honoraria (self), Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Bioinvent. M. Pérol: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Chugai; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Amgen. A. Sibille: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche. B. Markman: Honoraria (self): Novartis; Honoraria (self): Amgen. H. Bouchaab: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca. C. Schumann: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Boehringer Ingelheim. A.B. Klein: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. I. Diaz Perez: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. W. Sawyer: Full/Part-time employment, Contractor: AstraZeneca. M. Licour: Full/Part-time employment: AstraZeneca. D. Christoph: Honoraria (self), Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Non-remunerated activity/ies: Bayer; Honoraria (self), Non-remunerated activity/ies: Boehringer Ingelheim; Honoraria (self), Non-remunerated activity/ies: Bristol-Myers Squibb; Honoraria (self), Non-remunerated activity/ies: Chugai; Honoraria (self), Non-remunerated activity/ies: Merck Sharp & Dohme Corp., Honoraria (self), Non-remunerated activity/ies: Novartis; Honoraria (self), Non-remunerated activity/ies: Pfizer; Honoraria (self), Non-remunerated activity/ies: Roche; Honoraria (self), Non-remunerated activity/ies: Takeda. All other authors have declared no conflicts of interest.