Early safety assessment of durvalumab after sCRT in patients with stage III, unresectable NSCLC (PACIFIC-6)
AuthorsGarassino, M. C.
Bischoff, H. G.
Perez, I. D.
AffiliationFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;
MetadataShow full item record
AbstractBackground: 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
CitationGarassino 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.
JournalJournal of Thoracic Oncology
TypeMeetings and Proceedings