Abstract 142P
Background
There is a lack of real-world data on the effectiveness of durvalumab in the UK clinical practice setting. The ongoing observational CODAK (NCT04667312) study addresses this data gap.
Methods
CODAK is a non-interventional cohort study with retrospective data collection and a prospective observational period of patients (pts) with locally advanced, unresectable Stage III NSCLC initiated on durvalumab following concurrent or sequential CRT in the UK from September 2017 through December 2019. Data on demographic and clinical characteristics, treatment with durvalumab and outcomes were extracted from medical records of eligible pts identified at 10 participating centres by direct care teams (planned enrolment, 120 pts). The primary outcome is real-world overall survival (rwOS) rate at 12- and 24-months post durvalumab initiation. Interim results are reported.
Results
Data cut-off for this analysis was 24 March 2022 (median follow-up from durvalumab initiation: 16.5 months). In 47 pts for whom outcomes data on durvalumab were available, 36 (77%) were aged ≥60 years and 30 (64%) were male. The 12- and 24-month rwOS rate was 75.2% (95% CI: 63.5–89.1) and 50.9% (95% CI: 37.3–69.4), and the 12- and 24-month real-world progression-free survival (rwPFS) rate was 53.6% (95% CI: 40.9–70.4) and 43.3% (95% CI: 30.7–61.1), respectively. Median rwOS and rwPFS was not reached and 15.2 months (95% CI: 7.1–not reached), respectively. The median time to subsequent therapy was 16.0 months (95% CI: 11.0–not reached). Mean duration of durvalumab treatment for the 47 pts was 195 days (range: 8–456). Mean radiotherapy dose and number of fractions per pt was 60.8 Gy and 28.4, respectively. Durvalumab treatment was discontinued due to toxicity/adverse event (AE) in 11 (23%) pts. Pneumonitis/interstitial lung disease was the most common AE leading to discontinuation (reported in 8 [17%] pts).
Conclusions
Interim results from CODAK, based on both limited sample size and follow-up, demonstrate the effectiveness of consolidation durvalumab after CRT in a real-world cohort of UK pts with unresectable Stage III NSCLC. Safety data were comparable to results from PACIFIC (NCT02125461).
Clinical trial identification
NCT04667312.
Editorial acknowledgement
Medical writing and editorial assistance, was provided by Patrick Foley, PhD, of NexGen Healthcare (London, UK) and funded by AstraZeneca UK.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
K. Franks: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Financial Interests, Personal and Institutional, Writing Engagements: AstraZeneca; Financial Interests, Personal and Institutional, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal and Institutional, Other, Support for conferences: AstraZeneca; Financial Interests, Personal, Advisory Board: Bristol Meyers Squibb, Boehringer Ingelheim, Amgen, Lilly, Roche, Takeda; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Roche, Takeda; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Other, Support for conferences: Boehringer Ingelheim, Roche, Takeda. M. Ahmed: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, MSD; Financial Interests, Institutional, Principal Investigator: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb. D. Smith: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca. P.H. Shaw: Financial Interests, Personal, Advisory Board: Takeda, Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca. G. Banna: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Astellas. T. Talbot: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca. P. Taylor: Financial Interests, Institutional, Invited Speaker: AstraZeneca. B. Blak: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. L. Lindqvist: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. S.K. Paul: Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Speaker’s Bureau: AstraZeneca; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Full or part-time Employment: AstraZeneca; Financial Interests, Institutional, Ownership Interest: AstraZeneca; Financial Interests, Institutional, Stocks/Shares: AstraZeneca; Financial Interests, Institutional, Project Lead: AstraZeneca; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Leadership Role: AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker: NovoNordisk, Genentech, Amylin Pharmaceuticals, Sanofi Avensis, South Asian Health Foundation, Chinese Diabetes Society, American Diabetes Associatio, European Association for Studies in Diabetes; Financial Interests, Personal and Institutional, Research Grant: NovoNordisk, Genentech, Amylin Pharmaceuticals, Sanofi Avensis, South Asian Health Foundation, Chinese Diabetes Society, American Diabetes Associatio, European Association for Studies in Diabetes; Financial Interests, Personal and Institutional, Funding: NovoNordisk, Genentech, Amylin Pharmaceuticals, Sanofi Avensis; Financial Interests, Personal and Institutional, Project Lead: NovoNordisk, Genentech, Amylin Pharmaceuticals, Sanofi Avensis; Financial Interests, Personal and Institutional, Principal Investigator: NovoNordisk, Genentech, Amylin Pharmaceuticals, Sanofi Avensis. D. Vincent: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. All other authors have declared no conflicts of interest.