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Phase II evaluation of VDC-1101 in canine cutaneous T-cell lymphoma
M A Morges1, J H Burton, C F Saba
1Flint Animal Cancer Center, Colorado State University, Fort Collins, CO.
Background:
Canine cutaneous T-cell lymphoma (CTCL) is an uncommon disease for which efficacious therapies are lacking. The novel anticancer nucleotide prodrug VDC-1101 (formerly known as GS-9219) has shown efficacy in dogs with multicentric lymphoma. One of the observed adverse effects with this drug was a skin change characterized by hair loss, erythema, and pruritus, implying delivery of VDC-1101 to the skin.
Hypothesis/Objectives:
The primary study objective was to identify the objective response rate (ORR) to VDC-1101 in canine CTCL; secondary objectives included characterization of progression-free survival (PFS) and adverse events (AEs).
Animals:
Twelve dogs with chemotherapy-naïve or relapsed, histologically and immunohistochemically confirmed CTCL.
Methods:
Dogs received VDC-1101 as a 30-minute IV infusion once every 21 days. Prednisone (1 mg/kg PO q48h) was administered concurrently.
Results:
In 11 evaluable patients, responses included 1 complete response (CR), 4 partial responses (PR), 2 stable disease (SD), and 4 progressive disease for an ORR of 45% and biologic response rate (CR/PR/SD) of 64%. The median PFS was 37.5 days (26 to >399 days), which includes 1 durable and ongoing CR (>1 year). Gastrointestinal and hematologic AEs were mild; no dogs developed grade 3 or 4 AEs. Three dogs developed dermatopathies and 1 of these dogs was removed from the study as a result of this AE.
Conclusions And Clinical Importance:
VDC-1101 has activity against canine CTCL and could provide another treatment option in a disease process with a poor prognosis.
Insights
The novel anticancer drug VDC-1101 showed a 45% objective response rate in dogs with cutaneous T-cell lymphoma (CTCL). This study suggests VDC-1101 offers a new treatment option for canine CTCL, a disease with a poor prognosis.
Area of Science:
- Veterinary Oncology
- Dermatology
- Pharmacology
Background:
- Canine cutaneous T-cell lymphoma (CTCL) is an uncommon cancer with limited effective treatments.
- The novel nucleotide prodrug VDC-1101 demonstrated efficacy in canine multicentric lymphoma.
- Observed skin changes with VDC-1101 suggested drug delivery to the skin.
Purpose of the Study:
- To determine the objective response rate (ORR) of VDC-1101 in dogs with CTCL.
- To assess progression-free survival (PFS) and adverse events (AEs) associated with VDC-1101 treatment.
Main Methods:
- Twelve dogs with confirmed CTCL (chemotherapy-naïve or relapsed) were enrolled.
- Dogs received VDC-1101 intravenously every 21 days, with concurrent prednisone administration.
- Histological and immunohistochemical confirmation of CTCL was required.
Main Results:
- An ORR of 45% (1 CR, 4 PR) was observed in 11 evaluable dogs.
- The median PFS was 37.5 days, with one durable complete response lasting over a year.
- Mild gastrointestinal and hematologic adverse events were noted; three dogs experienced dermatopathies.
Conclusions:
- VDC-1101 exhibits activity against canine cutaneous T-cell lymphoma.
- This agent represents a potential new therapeutic option for canine CTCL, a condition with a generally poor prognosis.
