Pneumologie 2022; 76(S 01): S48
DOI: 10.1055/s-0042-1747796
Abstracts

Durvalumab +/− Tremelimumab + Chemotherapy as First-line Treatment for mNSCLC: Results from the Phase III POSEIDON Study

N Reinmuth
1   Asklepios Lung Clinic, Munich-Gauting, Germany
,
M L Johnson
2   Sarah Cannon Research Institute, Tennessee Oncology, Plcc, Nashville, Tn, USA
,
B C Cho
3   Yonsei Cancer Center, Seoul, Korea
,
A Luft
4   Leningrad Regional Clinical Hospital, St Petersburg, Russia
,
J A Alatorre-Alexander
5   Health Pharma Professional Research, Mexico City, Mexico
,
S L Geater
6   Prince of Songkla University, Songkhla, Thailand
,
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), Moscow, Russia
,
A Vasilyev
8   Railway Clinical Hospital of the Oao, St Petersburg, Russia
,
D Trukhin
9   Odessa Regional Oncological Dispensary, Odessa, Ukraine
,
S W Kim
10   Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
,
G Ursol
11   Acinus, Kropyvnytskyi, Ukraine
,
M Hussein
12   Florida Cancer Specialists – Sarah Cannon Research Institute, Leesburg, Fl, USA
,
F L Lim
13   Queen Mary University of London, London, United Kingdom
,
C T Yang
14   Chang Gung Memorial Hospital, Taoyuan City, Taiwan
,
L H Araujo
15   Instituto Nacional de Cancer-Inca, Rio de Janeiro, Brazil
,
H Saito
16   Kanagawa Cancer Center, Yokohama, Japan
,
X Shi
17   Astrazeneca, Gaithersburg, MD, USA
,
L Poole
18   Astrazeneca, Cambridge, UK
,
S Peters
19   Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland
,
E B Garon
20   David Geffen School of Medicine at Ucla, Los Angeles, Ca, USA
,
T Mok
21   Chinese University of Hong Kong, Hong Kong, China
,
J Rawluk
22   Medical Center University of Freiburg, Freiburg, Germany
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Introduction POSEIDON (NCT03164616) is a randomized, open label, global Phase 3 study evaluating durvalumab (D) ± tremelimumab (T) in combination with CTx regimens as first-line treatment for squamous (SQ) or non-squamous (NSQ) mNSCLC.

Methods Patients with treatment-naïve, EGFR/ALK wild-type mNSCLC were randomized (1:1:1) to receive: D 1500 mg + CTx q3w for 4 cycles followed by D 1500 mg q4w until progression; D 1500 mg + T 75 mg concurrently with CTx q3w for up to 4 cycles, followed by D 1500 mg q4w until progression, with one additional dose of T post CTx (5th dose); or CTx q3w for up to 6 cycles. The CTx options included platinum + pemetrexed (maintenance pemetrexed permitted) for NSQ histology, platinum + gemcitabine for SQ histology, or carboplatin + nab-paclitaxel for either histology. Randomization was stratified by PD-L1 expression, disease stage and histology. Primary endpoints were PFS by BICR and OS for D+CTx versus CTx; key secondary endpoints were PFS by BICR and OS for D+T+CTx versus CTx. Data cutoff dates were 24 July 2019 (PFS) and 12 March 2021 (OS and safety).

Results 1013 patients were randomized. PFS was significantly improved with D+CTx versus CTx, with a trend for OS improvement that did not reach statistical significance. Both OS and PFS were statistically significantly improved with D+T+CTx versus CTx ([Table 1]). The incidence of Grade 3/4 treatment-related AEs (TRAEs) was 51.8%, 44.6% and 44.4% with D+T+CTx, D+CTx and CTx, respectively, and 15.5%, 14.1% and 9.9% of patients had TRAEs leading to any study treatment discontinuation.

Conclusion In POSEIDON, D+T+CTx demonstrated statistically significant improvements in both PFS and OS versus CTx in patients with mNSCLC. PFS was significantly improved with D+CTx versus CTx, a positive trend for OS did not reach statistical significance. The safety profile was similar across all three arms. D+T+CTx may represent a new first-line treatment option for mNSCLC.



Publication History

Article published online:
11 May 2022

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