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Published on: September 25, 2018
Exploratory, Randomized, Dose-Response Study of the Anti-PD-L1 Antibody HFC-L1/c4G12 in Dogs with Pulmonary
Kenji Hosoya1,2, Sangho Kim1,2, Ryohei Kinoshita1,2
1Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Hokkaido University, Sapporo 060-0819, Japan.
Abstract:
Oral malignant melanoma (OMM) is a highly aggressive malignancy in dogs. The development of effective systemic therapies is urgently required to improve the treatment of canine OMM. Immunotherapy using immune checkpoint inhibitors (ICIs) has been investigated in canines following their dramatic success in human cancer treatment; however, there is still a need for extensive veterinary clinical studies to clarify and optimize their clinical benefits. Among the ICIs under development for canine cancer immunotherapy, c4G12 (HFC-L1), a canine chimeric anti-PD-L1 antibody, has shown promising efficacy in dogs with pulmonary metastatic OMM in previous clinical studies. However, the optimal dose of HFC-L1/c4G12 has not yet been determined. To explore the dose-response relationship of HFC-L1, a multicenter, randomized clinical study was conducted using three different doses (2, 5, or 10 mg/kg via intravenous infusion every 2 weeks) to treat dogs with pulmonary metastatic OMM (n = 8-9 per group). The safety profiles were similar among the dose groups, and numerically longer median overall survival was achieved in the higher dose groups (5 and 10 mg/kg) than in the 2 mg/kg group. Although the study was exploratory in nature with a small sample size, 5-10 mg/kg should be considered the preferred dose in future clinical studies using HFC-L1.
Insights
Determining the optimal dose for canine anti-PD-L1 antibody HFC-L1 in treating oral malignant melanoma is crucial. Higher doses (5-10 mg/kg) showed improved survival in dogs with metastatic cancer.
Area of Science:
- Veterinary Oncology
- Immunotherapy
- Canine Cancer Research
Background:
- Oral malignant melanoma (OMM) is an aggressive canine cancer requiring better systemic treatments.
- Immune checkpoint inhibitors (ICIs) show promise in human and canine cancer therapy.
- Canine anti-PD-L1 antibody c4G12 (HFC-L1) demonstrated efficacy but requires dose optimization.
Purpose of the Study:
- To determine the optimal dose of HFC-L1 for treating dogs with pulmonary metastatic OMM.
- To explore the dose-response relationship of HFC-L1 in canine cancer immunotherapy.
Main Methods:
- A multicenter, randomized clinical study involving 24-27 dogs with pulmonary metastatic OMM.
- Three different intravenous doses of HFC-L1 (2, 5, or 10 mg/kg) administered every two weeks.
- Assessment of safety profiles and overall survival across dose groups.
Main Results:
- Safety profiles were comparable across all tested HFC-L1 dose groups.
- Higher median overall survival was observed in dogs receiving 5 mg/kg and 10 mg/kg compared to 2 mg/kg.
- The study was exploratory with a small sample size.
Conclusions:
- The optimal dose range for HFC-L1 in treating canine pulmonary metastatic OMM is likely 5-10 mg/kg.
- These doses should be prioritized for future clinical investigations of HFC-L1.
- Further research is needed to confirm these findings in larger canine populations.
