Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma
Rutgers, The State University of New Jersey · University of Iowa · +6 more institutions
Abstract
In this open-label, multicenter, phase Ib trial of T-VEC in combination with ipilimumab, T-VEC was administered intratumorally in week 1 (10(6) plaque-forming units/mL), then in week 4 and every 2 weeks thereafter (10(8) plaque-forming units/mL). Ipilimumab (3 mg/kg) was administered intravenously every 3 weeks for four infusions, beginning in week 6. The primary end point was incidence of dose-limiting toxicities. Secondary end points were objective response rate by immune-related response criteria and safety.
Median duration of treatment with T-VEC was 13.3 weeks (range, 2.0 to 95.4 weeks). Median follow-up time for survival analysis was 20.0 months (1.0 to 25.4 months). Nineteen patients were included in the safety analysis. No dose-limiting toxicities occurred, and no new safety signals were detected. Grade 3/4 treatment-related adverse events (AEs) were seen in 26.3% of patients; 15.8% had AEs attributed to T-VEC, and 21.1% had AEs attributed to ipilimumab. The objective response rate was 50%, and 44% of patients had a durable response lasting ≥ 6 months. Eighteen-month progression-free survival was 50%; 18-month overall survival was 67%.
Citation impact
- FWCI
- 67.25
- Percentile
- 100%
- References
- 34
Authors
12- IPIgor PuzanovCorresponding
Rutgers, The State University of New Jersey, University of Iowa, Vanderbilt University, Pacific Environment, Angeles Clinic and Research Institute, Northern California Melanoma Center, Rutgers Cancer Institute, Vanderbilt University Medical Center
- MMMohammed Milhem
Rutgers, The State University of New Jersey, University of Iowa, Vanderbilt University, Pacific Environment, Angeles Clinic and Research Institute, Northern California Melanoma Center, Rutgers Cancer Institute, Vanderbilt University Medical Center
- DRDavid R. Minor
Rutgers, The State University of New Jersey, University of Iowa, Vanderbilt University, Pacific Environment, Angeles Clinic and Research Institute, Northern California Melanoma Center, Rutgers Cancer Institute, Vanderbilt University Medical Center
- OHOmid Hamid
Rutgers, The State University of New Jersey, University of Iowa, Vanderbilt University, Pacific Environment, Angeles Clinic and Research Institute, Northern California Melanoma Center, Rutgers Cancer Institute, Vanderbilt University Medical Center
- LALi Ai
Rutgers, The State University of New Jersey, University of Iowa, Vanderbilt University, Pacific Environment, Angeles Clinic and Research Institute, Northern California Melanoma Center, Rutgers Cancer Institute, Vanderbilt University Medical Center
Topics & keywords
- Medicine
- Ipilimumab
- Melanoma
- Oncolytic virus
- Metastatic melanoma
- Stage (stratigraphy)
- Internal medicine
- Oncology
- Good health and well-being