Loading...
Early safety assessment of durvalumab after sCRT in patients with stage III, unresectable NSCLC (PACIFIC-6)
Garassino, M. C. Mazieres, J. Reck, M. Delmonte, A. Bischoff, H. G. Bernabe, R. Perez, I. D. Sawyer, W. Trunova, N. Faivre-Finn, Corinne
Garassino, M. C.
Mazieres, J.
Reck, M.
Delmonte, A.
Bischoff, H. G.
Bernabe, R.
Perez, I. D.
Sawyer, W.
Trunova, N.
Faivre-Finn, Corinne
Citations
Altmetric:
Abstract
Background: In the ph III PACIFIC trial, durvalumab after concurrent
chemoradiotherapy (cCRT) significantly improved survival outcomes in
pts with Stage III, unresectable NSCLC with manageable safety. As many
pts are ineligible for cCRT, we aimed to assess durvalumab after
sequential (s)CRT in pts with Stage III, unresectable NSCLC in the ph II
PACIFIC-6 trial (NCT03693300).
Methods: Up to 120 pts with ECOG PS ≤2 and no progression after sCRT
will receive durvalumab 1500 mg IV q4w ≤24 months or until
progression, unacceptable toxicity or consent withdrawal. The primary
endpoint is assessment of safety/tolerability, defined by gr 3/4
treatment-related AEs occurring within 6 months. Pre-specified early
assessment was planned after ≥50 pts in a PS 0/1 cohort (∼100–120
expected) had received durvalumab ≥6 months.
Results: As of August 24, 2020, 50 pts with ECOG PS 0/1 (46%/54%)
had received durvalumab for a median 24.0 weeks. Median agewas 67.0
years; 64% were male; 64% had adenocarcinoma histology; 38%/52%/
10% had Stage IIIA/B/C disease; and 48%/52% had PD-L1 tumor cell
expression ≥/< 1%. Many pts had past/present medical conditions,
including vascular (62%), metabolism (54%) and respiratory (50%)
disorders. Pts had received a median 4 CT cycles, with 68% receiving a
total RT dose of ≥54 to ≤60 Gy and 32% receiving >60 to ≤66 Gy. In
most pts (84%), CT and RT did not overlap. Best response to prior sCRT
(RECIST 1.1) included PR (74%) and SD (18%). In all, 88% had any AEs
and 12% had gr 3/4 AEs; 70% had any possibly related AEs (PRAEs) and
4% had gr 3/4 PRAEs (including 2% with the gr 3/4 PRAE
pneumonitis). 22% had SAEs (10% PRSAEs) and 2 pts had fatal AEs
(1 pt fatal PRAE). 72% had AESIs, including pneumonitis (32%) and
dermatitis/rash (28%). 9/25 pts who discontinued did so due to AEs,
most commonly pneumonitis (n = 8).
Conclusions: Based on early assessment, durvalumab after sCRT
appears to have a similar safety profile to that with durvalumab after
cCRT in PACIFIC pts with Stage III, unresectable NSCLC. Full cohort
results for safety primary analysis in the near future are awaited
Description
Date
2021
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Garassino MC, Mazieres J, Reck M, Delmonte A, Bischoff HG, Bernabe R, et al. 78MO Early safety assessment of durvalumab after sCRT in patients with stage III, unresectable NSCLC (PACIFIC-6). Journal of Thoracic Oncology. 2021 Apr;16(4):S737.