Durvalumab +/− Tremelimumab + Chemotherapy as First-line Treatment for mNSCLC: Results from the Phase III POSEIDON Study
Year: 2022
Type: article
Study design: Clinical Trial
Abstract: 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 © 2022. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany
Source: Pneumologie
Institutions: Asklepios Fachkliniken München-Gauting, Sarah Cannon, Tennessee Oncology, Yonsei Cancer Hospital, Prince of Songkla University, Russian Cancer Research Center NN Blokhin, Ministry of Health of the Russian Federation, Russian Railways, Asan Medical Center, University of Ulsan, Queen Mary University of London, Taoyuan Chang Gung Memorial Hospital, Linkou Chang Gung Memorial Hospital, Instituto Nacional de Câncer - INCA, Kanagawa Cancer Center, AstraZeneca (United States), AstraZeneca (United Kingdom), Centre Hospitalier Universitaire Vaudois, University of California, Los Angeles, Chinese University of Hong Kong, University of Freiburg, University Medical Center Freiburg
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4293147942