188O - Patient-reported outcomes (PROs) with perioperative durvalumab in resectable NSCLC (AEGEAN)

Background

In AEGEAN, perioperative durvalumab (D) + neoadj CT significantly improved event-free survival and pathological complete response vs neoadj CT alone in pts with resectable NSCLC (R-NSCLC), with a safety profile consistent with the individual agents. Here, we report PROs during the neoadj and adj Tx periods.

Methods

AEGEAN is a double-blind, PBO-controlled study (NCT03800134). Pts ≥18 yr with Tx-naïve R-NSCLC (stage II–IIIB[N2]; AJCC 8th ed) and ECOG PS 0/1 were randomised (1:1) to neoadj platinum-based CT plus D or PBO IV (Q3W, 4 cycles), followed by D or PBO IV (Q4W, 12 cycles), respectively, after surgery. PROs were assessed using the EORTC QLQ-C30 (both Tx periods) and QLQ-LC13 (neoadj Tx) questionnaires and analysed in the modified ITT (mITT) population (neoadj Tx), or its resected subpopulation (adj Tx), which excluded pts with documented EGFR/ALK aberrations. Changes frombaseline (BL) in key symptoms, physical (PF) and role (RF) functioning, and global health status (GHS)/quality of life (QoL) were analysed with a mixed model for repeated measures (MMRM). A ≥10-point change (scores 0–100) was defined as clinically meaningful.

Results

Questionnaire completion rates across all visits remained high in both arms (>79%). Mean neoadj and adj BL PRO scores were generally well balanced between arms. No clinically meaningful MMRM-adjusted mean changes from BL in PRO scores (avg over all visits) were observed in either arm during the neoadj or adj period (Table). There were no apparent between-arm differences in the proportions of pts reporting Tx-related symptoms, assessed by PRO-CTCAE (exploratory endpoint), except pts reporting rash, which was more prevalent in the D vs PBO arm during neoadj Tx (data to be presented).

*Avg overall visits. Higher scores=more symptom burden or better function/QoL.

Conclusions

Adding perioperative D to neoadj CT maintained QoL, functioning, and symptoms vs neoadj CT alone. Together with the significant efficacy improvements and manageable AE profile, these results further support perioperative D as a new Tx option for pts with R-NSCLC.

Clinical trial identification

NCT03800134 (release date: January 11, 2019).

Editorial acknowledgement

Medical writing support for the development of this abstract, under the direction of the authors, was provided by Andrew Gannon (New York, NY, USA) and Mark Richardson (Manchester, UK) of Ashfield MedComms, an Inizio company, and was funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

G. Pasello: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, MSD, Amgen, Pfizer, Lilly; Financial Interests, Personal, Writing Engagements: Pfizer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Roche, MSD, BMS; Pfizer, Amgen, Novartis, Lilly, J&J; Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, MSD, Lilly, J&J; Financial Interests, Institutional, Research Grant: AstraZeneca, MSD, Roche; Financial Interests, Institutional, Funding: AstraZeneca, MSD, Roche; Financial Interests, Personal, Project Lead: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca, Roche, MSD, Lilly, Amgen, Novartis, Merck; Financial Interests, Personal, Advisory Role: AstraZeneca, Roche, MSD, Lilly, J&J. M. Reck: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Lilly, MSD, Merck, Novartis, Regeneron, Roche, Sanofi, GSK, Pfizer, Pierre Fabre, AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, BioNTech, Boehringer Ingelheim, Daiichi Sankyo, Gilead, MSD, Mirati, Pfizer, Regeneron, Roche, Sanofi, GSK, Lilly, Pierre Fabre; Financial Interests, Personal, Other, Member of DMSB: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Amgen, Boehringer Ingelheim, BeiGene, Daiichi Sankyo, GSK, BMS, Lilly, MSD, Pfizer Seagen, Regeneron, Roche, Nuvalent. D. Harpole: Non-Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Personal and Institutional, Speaker’s Bureau: AstraZeneca; Non-Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca. T. Mitsudomi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Boehringer Ingelheim, Pfizer, Taiho, Eli Lilly, Daiichi Sankyo, Ono, ThermoFisher, BMS, Takeda, Janssen, MSD, Novartis, Amgen, Merck Biopharma, Kyorin; Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Boehringer Ingelheim, Pfizer, Novartis, MSD, BMS, Ono, Taiho, Takeda, Janssen, Daiichi Sankyo, Regeneron; Financial Interests, Institutional, Research Grant: BridgeBIo, Boehringer Ingelheim, Ono, Chugai; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca, BMS. T. Winder: Financial Interests, Personal, Invited Speaker: Roche, MSD, BMS, AstraZeneca, Daiichi Sankyo, Pierre Fabre, Servier; Financial Interests, Personal, Speaker’s Bureau: Roche, MSD, BMS, AstraZeneca, Daiichi Sankyo, Pierre Fabre, Servier; Financial Interests, Personal, Advisory Board: Roche, MSD, BMS, AstraZeneca, Daiichi Sankyo, Pierre Fabre, Servier. R. Zukov: Financial Interests, Personal and Institutional, Principal Investigator: A.I.Kryzhanovsky Krasnoyarsk Regional Clinical oncology center. G.E. Garbaos: Non-Financial Interests, Institutional, Principal Investigator: Fundacion Estudos Clinicos. T.V. Tran: Financial Interests, Personal, Writing Engagements: AstraZeneca; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca. R. Lai: Financial Interests, Personal and Institutional, Full or part-time Employment: Evinova, AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. H. Mann: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. T. Fouad: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. J. Heymach: Financial Interests, Personal, Full or part-time Employment: The University of Texas MD Anderson Cancer Center; Financial Interests, Personal, Royalties: Spectrum; Financial Interests, Institutional, Funding: AstraZeneca, Boehringer Ingelheim, Mirati, Bristol Myers Squibb and Takeda; Financial Interests, Personal, Advisory Board: AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech AG, Blueprint Medicines, BI, BMS, Chugai Pharmaceutical, Curio Science, DAVA Oncology, Eli Lilly & Co, EMD Serono, Genentech, GSK, IDEOlogy Health, Immunocore, InterVenn Biosciences, Janssen Biotech, Janssen Pharmaceuticals, Mirati Therapeutics, Moffitt Cancer Center, ModeX, Nexus Health Systems, Novartis Pharmaceuticals, OncoCyte, RefleXion, Regeneron Pharmaceuticals, Roche, Sandoz Pharmaceutical, Sanofi, Spectrum Pharmaceuticals, Takeda, uniQure. All other authors have declared no conflicts of interest.