79MO PACIFIC-R: Real-world characteristics of unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy

Background: The PACIFIC regimen (up to 12 months of durvalumab treatment in pts with unresectable stage III non-small cell lung cancer [NSCLC] who did not progress after platinum-based concurrent chemoradiotherapy [cCRT]) is now standard of care. Insights into durvalumab use outside the clinical trial setting are needed. Methods: PACIFIC-R (NCT03798535) is a large international, observational study of pts with unresectable Stage III NSCLC who received ≥1 dose of durvalumab (10 mg/kg Q2W) as part of an AstraZeneca-initiated expanded access programme (September 2017–December 2018). Pts must have completed platinum-based chemotherapy (CT) concurrent or sequential to radiotherapy (RT) within the previous 12 weeks without evidence of disease progression. Data will be retrospectively collected up to 5 years after enrolment. Results: The full analysis set (N = 1155) showed no significant differences in baseline demographics and disease characteristics by PD-L1 expression status (tested pts: ≥1% [n = 574] vs <1% [n = 138]). A majority of pts had received cCRT (n = 893). Pts who had received sequential CRT (sCRT; n = 163) were generally older (37.4% vs 28.4% aged ≥70 years); a higher proportion had larger tumour volume (25.0% vs 15.9% >70 mm). Median total RT dose (overall: 65 Gy) and duration (overall: 1.5 months) reflected local practice. For platinum-based CT regimens, vinorelbine was favoured in France/Germany/UK; paclitaxel in Australia/Israel; and etoposide in Netherlands/Belgium/Norway. Median CT duration ranged from 0.8 to 2.3 months (overall: 1.6 months). Median time of durvalumab start from end of CRT varied from 39 to 89 days (overall: 52 days). Most commonly reported adverse events of special interest (AESIs) in the first 3 months of durvalumab treatment were pneumonitis (10.6%) and endocrinopathies (6.8%), leading to permanent treatment discontinuation in 4.8% and 0.2% of pts, respectively. Conclusions: Real-world characteristics of PACIFIC-R pts reflect the PACIFIC population (only cCRT was allowed per protocol in PACIFIC). Time to durvalumab start from end of CRT was longer than in PACIFIC (except France: durvalumab start ≤6 weeks from end of CRT per protocol). Permanent discontinuation due to AESIs was infrequent. Clinical trial identification: NCT03798535. Editorial acknowledgement: Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Carole Mongin-Bulewski of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca. Legal entity responsible for the study: AstraZeneca plc. Funding: AstraZeneca. Disclosure: F. McDonald: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self): Elekta; Advisory/Consultancy: Accuracy; Research grant/Funding (institution): MSD. M.C. Garassino: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, MISP in Thimic malignancies; Speaker, advisory board: Eli Lilly; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Local PI, Enrollment in clinical Trials in NSCLC; Speaker; advisory board: Otsuka Pharma; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment and Steering Committee in clinical Trials in NSCLC; consulting, advisory boards, lectures;steering committee: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; advisory board: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Roche; Advisory/Consultancy, Research grant/Funding (self), PI, MISP MISP Sunitinib in thymic malignancies; advisory board: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Institutional Grants; Advisory board; Speaker: Incyte; Advisory/Consultancy: Inivata; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Research grant/Funding (self), PI, Enrollment in clinical Trials Thimic malignancies: Tiziana Sciences; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Clovis; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Merck Serono; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in Mesothelioma; advisory board: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; consulting, advisory boards, lectures; steering committee: MSD; Advisory/Consultancy, Research grant/Funding (self), Local PI, Enrollment and Steering committee in clinical Trials in NSCLC; advisory board: GlaxoSmithKline S.p.A.; Advisory/Consultancy, Research grant/Funding (self), Advisory board; PI, Enrollment in clinical Trials: Sanofi-Aventis; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Spectrum Pharmaceutcials; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Blueprint Medicine; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (self): Janssen; Non-remunerated activity/ies, Principal Investigator Keynote 189;MISP pembrolizumab in low expressors PD-L1(A.R. Filippi: Advisory/Consultancy, Scientific consultancy; advisory board: AstraZeneca; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: MSD. D. Christoph: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: AstraZeneca; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Boehringer Ingelheim; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bristol-Myers Squibb; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Chugai; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Merck, Sharp & Dohme; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Novartis; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Pfizer; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Roche; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Takeda; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bayer. A. Agbarya: Non-remunerated activity/ies, Non-financial support: AstraZeneca. M. Van den Heuvel: Research grant/Funding (self), Research projects, not related to Pacific R: AstraZeneca. C. Chouaid: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Sanofi Aventis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Amgen. E. Pichon: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bristol Myers Squibb; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Takeda; Non-remunerated activity/ies, Non-financial support: Merck Serono; Non-remunerated activity/ies, Non-financial support: AstraZeneca; Honoraria (self), Personal fees: Roche. S. Siva: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Speaker fees to institution and travel: AstraZeneca; Research grant/Funding (self), Research grant, un-related: Varian Industries. B. Solomon: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck. L. Decoster: Research grant/Funding (self), Data monitoring: AstraZeneca; Travel/Accommodation/Expenses, Travel grant: Roche Belgium; Research grant/Funding (self): Boehringer Ingelheim; Travel/Accommodation/Expenses, Travel grant: MSD Belgium. W. Sawyer: Full/Part-time employment: AstraZeneca. M. Licour: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment/stock options: AstraZeneca. N. Girard: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: AstraZeneca; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: BMS; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: MSD. All other authors have declared no conflicts of interest.