Pneumologie 2023; 77(S 01): S7-S8
DOI: 10.1055/s-0043-1760883
Abstracts

Durvalumab (D)+/− tremelimumab (T)+chemotherapy (CT) in 1L metastatic (m) NSCLC: overall survival (OS) update from POSEIDON after median follow-up (mFU) of approximately 4 years (y)

F Griesinger
1   Pius-Hospital Oldenburg; University Medicine Oldenburg; Hematology/Oncology, Internal Medicine-Oncology
,
M Johnson
2   Sarah Cannon Research Institute, Tennessee Oncology, Pllc
,
B Cho
3   Yonsei Cancer Center
,
A Luft
4   Leningrad Regional Clinical Hospital
,
J Alatorre-Alexander
5   Health Pharma Professional Research
,
S Geater
6   Prince of Songkla University
,
K Laktionov
7   Federal State Budgetary Institution “n.N. Blokhin National Medical Research Center of Oncology” of the Ministry of Health of the Russian Federation (N.N. Blokhin Nmrco)
,
S Kim
8   Asan Medical Center, University of Ulsan College of Medicine
,
G Ursol
9   Acinus
,
M Hussein
10   Florida Cancer Specialists – Sarah Cannon Research Institute
,
F Lim
11   Queen Mary University of London
,
C Yang
12   Chang Gung Memorial Hospital
,
L Araujo
13   Instituto Nacional de Cancer-Inca
,
H Saito
14   Kanagawa Cancer Center
,
N Reinmuth
15   Asklepios Lungenklinik
,
Z Lai
16   Astrazeneca
,
H Mann
16   Astrazeneca
,
X Shi
16   Astrazeneca
,
S Peters
17   Centre Hospitalier Universitaire Vaudois, Lausanne University
,
E Garon
18   David Geffen School of Medicine at Ucla
,
T Mok
19   Chinese University of Hong Kong
,
J Kern
20   Standort Missioklinik, Klinikum Würzburg Mitte gGmbH
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Background In the Phase 3 POSEIDON study, 1L T+D+CT demonstrated statistically significant improvements in PFS and OS (OS HR 0.77; 95% CI 0.65-0.92; p=0.0030; mFU 34.9 mo in censored pts) vs CT alone in pts with mNSCLC. D+CT showed a statistically significant improvement in PFS and a positive trend for OS improvement vs CT that did not reach significance (OS HR 0.86; 95% CI 0.72-1.02; p=0.0758). Here we report an updated exploratory analysis of OS, and histology and mutational status subgroups, after a mFU of ~4y.

Methods Pts with EGFR/ALK wild-type mNSCLC were randomised 1:1:1 to 1L D (until progression)±limited-course T (up to 5 doses)+platinum-based CT (up to 4 cycles); or CT (up to 6 cycles). Alpha-controlled endpoints were PFS and OS for D+CT vs CT and T+D+CT vs CT. Pt tumours were molecularly characterised via sequencing of tissue and/or ctDNA samples.

Results At an updated data cutoff (DCO) of 11 Mar 2022 (mFU 46.5 mo in censored pts), T+D+CT continued to show OS benefit vs CT (HR 0.75; 95% CI 0.63–0.88) with an estimated 25.0% of pts alive at 3 y vs 13.6%. D+CT continued to numerically improve OS vs CT (HR 0.84; 95% CI 0.71–0.99; 3 y OS 20.7%). Consistent with results at the earlier DCO, OS benefit appeared more pronounced with T+D+CT vs CT in pts with non-squamous (than squamous; data will be presented) histology. A trend for OS benefit with T+D+CT vs CT continued to be observed in non-squamous subgroups with mutations in STK11, KEAP1 or KRAS (data will be presented). No new safety signals were identified based on collection of serious AEs during long-term FU.

Conclusions The results of this exploratory analysis from POSEIDON, after mFU of ~4 y, demonstrate the durable long-term OS benefit of adding a limited course of T to D and 4 cycles of CT. These data support the use of this regimen as a 1L treatment option for pts with mNSCLC, including harder-to-treat mutational subgroups such as STK11m, KEAP1m or KRASm.

Clinical trial identification

NCT03164616

Funded by AstraZeneca.



Publication History

Article published online:
09 March 2023

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