Abstract published. Note initial 49% increase in size of lesion in case of pseudoprogression in the eventual CR biliary cancer case.
749 Poster Session
Oncolytic virus CF33-hNIS monotherapy for the treatment of gastrointestinal (GI)
malignancies.
Daneng Li, Anthony F. Shields, Hirva Mamdani, Jennifer Leddon, Patrick M. Travis, Colt A. Egelston, Oscar Colunga Flores, Stanley R. Hamilton, Janet Austria, Amanda Seiz,
Sharon Yavrom, John Chong Han Byon, Paul Paul Woodard, Grey A Wilkinson; City of Hope National Comprehensive Cancer Center, Duarte, CA; Barbara Ann Karmanos
Cancer Institute, Detroit, MI; University of Cincinnati Medical Center, Cincinnati, OH; Highlands Oncology Group, Rogers, AR; City of Hope National Medical Center, Duarte,
CA; Imugene Limited, Sydney, Australia
Background: CF33-hNIS is a novel chimeric DNA vaccinia virus engineered with the human
sodium-iodide symporter (hNIS) gene. CF33-hNIS selectively replicates in tumor cells leading
to cell lysis and the release of tumor- and virus-associated antigens stimulating antitumor
immunity. Here, we report results of patients with GI malignancies enrolled on a first-inhuman phase 1 ascending, multiple dose, safety and tolerability study of CF33-hNIS, administered intratumorally (IT) or intravenously (IV) in adult patients with metastatic or advanced
solid tumors (MAST). Methods: The MAST study is evaluating the safety of CF33-hNIS
administered IT or IV, alone or in combination with pembrolizumab in patients with advanced
or metastatic solid tumors with $ 2 prior lines of therapy (NCT05346484). CF33-hNIS is
administered in 21-day cycles on C1D1 and C1D8, then D1 of each cycle thereafter. Pembrolizumab begins C2D1 for the combination groups and is administered Q3W. The co-primary
endpoints are safety and to identify the recommended phase 2 dose. Secondary endpoints
include objective response rate according to RECIST v1.1 and iRECIST, and to assess levels of
viral replication via Single-Photon Emission Computerized Tomography (SPECT) with
technetium-99. Results: As of Aug 2023, we report early results from seven patients with GI
malignancies who received CF33-hNIS alone, including: colorectal cancer (3), bile duct (2),
pancreatic (1) and hepatocellular carcinoma (1). The disease control rate is 86%. Notably one
patient with cholangiocarcinoma, treated IT with 3.0x107 PFU, presented with pseudoprogression with a 49% increase in tumor burden after two cycles of therapy. By the 4th cycle they
achieved a complete response (CR) with no known recurrence. A second patient with bile duct
cancer, who previously progressed on checkpoint blockade therapy, achieved stable disease
for .5 months upon receiving IV-administered CF33-hNIS (3.0x107 PFU). Treatment-related
adverse events for the CR patient included grade 1 fever and injection site reaction. All other
patients experienced no treatment-related adverse events. SPECT analysis of the CR patient
reveals intense levels of viral replication within the injected lesion and a concomitant increase
in Th1 cytokines in cycle three that coordinated with tumor reduction. In-depth immunological
changes in peripheral blood and on-treatment tumor biopsies will be presented. Conclusions:
CF33-hNIS can replicate within cholangiocarcinoma lesions, as shown by SPECT imaging, and
drive immunological changes known to promote antitumor immunity. CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies, including
cholangiocarcinoma, a rare disease with an unmet medical need. Treatment with CF33-hNIS
monotherapy was well tolerated and the study has advanced to examine combination therapy
with pembrolizumab. Clinical trial information: NCT05346484. Research Sponsor: Imugene
Limited.
https://s3.amazonaws.com/files.oncologymeetings.org/prod/s3fs-public/2024-01/GI24-Other-GI-Cancer.pdf
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- Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals
Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-100
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