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Ref Type Abstract
PMID
Authors V. Gounant, L. Greillier, C. Mascaux, F. Pinquie, D. Carmier, L. Moreau, B. Roch, D. Debieuvre, X. Dhalluin, E. Giroux-Leprieur, E. Berton, A. Rabeau, J. Raimbourg, A. Dixmier, C. Naltet, A. Khalil, L. Ezzeddine, A. Langlais, F. Morin, M. Duruisseaux
Title 1324P Durvalumab in treatment-naive, stage IV non-small cell lung cancer (NSCLC) patients (pts), with ECOG performance status (PS) 2-3 and high PD-L1 tumour expression: Results of IFCT-1802 SAVIMMUNE phase II trial
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 35 Supplement 2 September 2024 S842 Ann Oncol
URL https://www.annalsofoncology.org/article/S0923-7534(24)02898-9/fulltext
Abstract Text Background PS2-3 is a prognostic factor associated with poor survival and higher incidence of chemotherapy-related adverse events (AE), while the impact of poor PS on immunotherapy (IO) safety and efficacy is less documented. We sought to prospectively assess front-line durvalumab in PS2-3 pts with advanced NSCLC and high PD-L1 expression. Methods In this single-arm, multicenter, phase II trial, PS2-3 pts with metastatic ALK-/EGFRwt NSCLC, PD-L1 positive (TPS ≥25%), without brain metastases, received 1500 mg durvalumab every 4 weeks until progression or toxicity. Primary endpoint was safety defined as the incidence of grade ≥3 treatment-related AE (TRAE) during the first 8 weeks (NCI CTCAE v.5.0). Using a 2-step binomial proportion test (O’Brien-Fleming’s procedure), 67 pts were to be included, to achieve 95% power, with 5% type I error rate, to observe <40% (H0) G3-5 events. Secondary objectives included intent-to-treat blinded independent centrally reviewed (BICR) objective response rate (ORR) and progression-free survival (PFS), median duration of response (DoR), overall survival (OS) and PS improvement at 8 weeks. Results Overall, 50 pts (median age 68 yrs, PS2 n=40; PS3 n=10) were enrolled between Oct 2020 and Jul 2023. The trial was stopped due to slow accrual. Median follow-up was 15.7 months. Median number of cycles was 3 (1-26). Grade ≥3 TRAE during the first 8 weeks occurred in 10% of pts (95% CI 1.7%–18.3%). No grade 5 TRAE were reported. BICR ORR at 8 weeks (partial responses only) was 26% (95% CI 13.8%–38.2%) and 24% (95% CI 12.2%–35.8%) were confirmed at 16 weeks. Median DoR was 11.3 months (95% CI, 6.4 to NR). Median PFS was 2.3 months (95% CI 1.7–5.6). Median OS was 6.9 months (95% CI 3.9–31.1) with a 40% (95% CI 26. 1–53.7) 12-month OS rate. Median OS in PS2 pts was 9.7 months (95% CI 4.4-NR) and in PS3 pts was 3.0 months (95% CI 0.2-5.6). 12 (44%) of 27 pts with evaluable PS at 8 weeks of durvalumab treatment (95% CI, 25.7%-63.2%) had improved PS (p= 0.01). Conclusions In PS2-3 pts with advanced NSCLC and high PD-L1 expression (TPS ≥25%), front-line durvalumab is safe and showed interesting activity. Patient Reported Outcomes will be presented at the meeting. Clinical trial identification EudraCT 2018-004742-42.

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