Abstract CT005: AEGEAN: A phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC

• DOI: 10.1158/1538-7445.am2023-ct005
• Publication Date: 2023-05-30T18:57:36Z
• Authors: John V. Heymach; David Harpole; Tetsuya Mitsudomi; Janis M. Taube; Gabriella Galffy; Maximilian Hochmair; Thomas Winder; Ruslan Zukov; Gabriel Garbaos; Shugeng Gao; Hiroaki Kuroda; Jian You; Kang-Yun Lee; Lorenzo Antonuzzo; Mike Aperghis; Gary J. Doherty; Helen Mann; Tamer M. Fouad; Martin Reck
• Keywords: Durvalumab; Clinical endpoint

Abstract Background: Recent trials have demonstrated the clinical benefit of immunotherapy in either neoadjuvant or adjuvant resectable (R) NSCLC setting. AEGEAN (NCT03800134) is a randomized, double-blind, placebo (PBO)-controlled trial assessing durvalumab (D) + chemotherapy (CT) followed by surgery (Sx) and D patients (pts) with R-NSCLC. Methods: Adults treatment (Tx)-naïve R-NSCLC (stage II-IIIB[N2]; AJCC 8th ed) ECOG PS 0/1 were randomized (1:1) to receive 1500 mg PBO IV platinum-based CT (every 3 weeks [Q3W] for 4 cycles) before Sx, then further (Q4W, up 12 cycles). Pts stratified disease stage (II vs III) PD-L1 tumor cell expression (<1% ≥1%, Ventana SP263). documented EGFR/ALK aberrations excluded from modified intent-to-treat (mITT) population efficacy analyses. The primary endpoints pathological complete response (pCR), evaluated centrally, event-free survival (EFS; using RECIST v1.1), BICR. Safety was assessed all pts who received ≥1 study Tx dose. Results: Between Jan 2, 2019, Apr 19, 2022, 802 ITT (n=740 mITT population) whom 799 (D arm, n=400; n=399). Baseline characteristics largely balanced (mITT). Overall, 84.7% arm 87.2% completed cycles platinum-doublet 77.6% 76.7%, respectively, Sx As Nov 10, 2022 (data cutoff), median EFS follow-up censored 11.7 months pCR rate significantly higher prolonged arms (Table). In safety analysis set, maximum grade 3/4 any-cause AEs occurred 42.3% 43.4% arms, during overall period. Conclusions: met both its improved EFS. Perioperative plus associated manageable profile. Clinical identification: NCT03800134 (release date: January 11, 2019) Endpoint effect P value n/N: 63/366 (17.2%) 16/374 (4.3%) Difference (95% CI), %: 13.0 (8.7-17.6)a 0.000036 (assessed at IA)b n events/N: 98/366 (26.8%) 138/374 (36.9%) HR CI): 0.68 (0.53-0.88)d 0.003902e Median months: NR (31.9-NR)c 25.9 (18.9-NR)c aCIs Miettinen Nurminen’s method. bStatistical significance achieved IA (402 pts; data cutoff, 14, 2022); no testing performed FA. statistically significant p-value based on Cochran-Mantel-Haenszel test. cKaplan-Meier dStratified Cox proportional hazards model. eStratified log-rank CI, confidence interval; FA, final analysis; HR, hazard ratio; IA, interim NR, not reached. Citation Format: John V. Heymach, David Harpole, Tetsuya Mitsudomi, Janis M. Taube, Gabriella Galffy, Maximilian Hochmair, Thomas Winder, Ruslan Zukov, Gabriel Garbaos, Shugeng Gao, Hiroaki Kuroda, Jian You, Kang-Yun Lee, Lorenzo Antonuzzo, Mike Aperghis, Gary J. Doherty, Helen Mann, Tamer Fouad, Martin Reck. AEGEAN: A phase [abstract]. In: Proceedings American Association Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials Late-Breaking Research); 2023 14-19; Orlando, FL. Philadelphia (PA): AACR; Res 2023;83(8_Suppl):Abstract nr CT005.