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2017 ; 5
(1
): 71
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Phase 1 study of intravenous administration of the chimeric adenovirus
enadenotucirev in patients undergoing primary tumor resection
#MMPMID28923104
Garcia-Carbonero R
; Salazar R
; Duran I
; Osman-Garcia I
; Paz-Ares L
; Bozada JM
; Boni V
; Blanc C
; Seymour L
; Beadle J
; Alvis S
; Champion B
; Calvo E
; Fisher K
J Immunother Cancer
2017[Sep]; 5
(1
): 71
PMID28923104
show ga
BACKGROUND: Enadenotucirev (formerly ColoAd1) is a tumor-selective chimeric
adenovirus with demonstrated preclinical activity. This phase 1 Mechanism of
Action study assessed intravenous (IV) delivery of enadenotucirev in patients
with resectable colorectal cancer (CRC), non-small-cell lung cancer (NSCLC),
urothelial cell cancer (UCC), and renal cell cancer (RCC) with a comparator
intratumoral (IT) dosed CRC patient cohort. METHODS: Seventeen patients scheduled
for primary tumor resection were enrolled. IT injection of enadenotucirev (CRC
only) was administered as a single dose (? 3 × 10(11) viral particles [vp]) on
day 1, followed by resection during days 8-15. IV infusion of enadenotucirev was
administered by three separate doses (1 × 10(12) vp) on days 1, 3, and 5,
followed by resection during days 8-15 (CRC) or days 10-25 (NSCLC, UCC, and RCC).
Enadenotucirev activity was measured using immunohistochemical staining of
nuclear viral hexon and quantitative polymerase chain reaction for viral genomic
DNA. RESULTS: Delivery of enadenotucirev was observed in most tumor samples
following IV infusion, with little or no demonstrable activity in normal tissue.
This virus delivery (by both IV and IT dosing) was accompanied by high local
CD8(+) cell infiltration in 80% of tested tumor samples, suggesting a potential
enadenotucirev-driven immune response. Both methods of enadenotucirev delivery
were well tolerated, with no treatment-associated serious adverse events.
CONCLUSIONS: This study provides key delivery and feasibility data to support the
use of IV infusion of enadenotucirev, or therapeutic transgene-bearing
derivatives of it, in clinical trials across a range of epithelial tumors,
including the ongoing combination study of enadenotucirev with the checkpoint
inhibitor nivolumab. It also provides insights into the potential
immune-stimulating properties of enadenotucirev. TRIAL REGISTRATION: This MOA
study was a phase 1, multicenter, non-randomized, open-label study to investigate
the administration of enadenotucirev in a preoperative setting
(ClinicalTrials.gov: NCT02053220).
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