Reference Detail

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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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	lung non-small cell carcinoma	predicted - sensitive	Durvalumab	Phase II	Actionable	In a Phase II trial (SAVIMMUNE), Imfinzi (durvalumab) treatment demonstrated safety and resulted in an 8-week objective response rate (ORR) of 26%, and 16-week ORR of 24%, median progression-free survival of 2.3 months, median overall survival (OS) of 6.9 months, a 12-month OS rate of 40%, and a median duration of response of 11.3 months in patients with advanced CD274 (PD-L1)-positive (TPS >/=25%) non-small cell lung cancer with a performance score of 2 or 3 (Ann Oncol (2024) 35 (suppl_2): S842).	detail...