| General information |
| Database: | DB00166 |
| Objective: | Results from the firstinhumanphase I trial of the antiPD1 antibody BMS936558 in patients with treatmentrefractory solid tumors, including safety, tolerability, pharmacodynamics, and immunologic correlates, have been previously reported. Here, they provide longterm followup on three patients from that trial who sustained objective tumor regressions off therapy, and test the hypothesis that reinduction therapy for late tumor recurrence can be effective. |
| Authors: | Lipson EJ, et al |
| Title: | Durable cancer regression offtreatment and effective reinduction therapy with an antiPD1 antibody. |
| Journal: | Clin Cancer Res |
| Year: | 2013 |
| PMID: | 23169436 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | BMS936558
|
| Target: | PD1
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | longterm followup on patients from the firstinhuman trial of BMS9III6558 |
| Key Patients Feature: | patients with colorectal cancer, renal cell cancer, and melanoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | achieved objective responses on an intermittent dosing regimen of BMS936558. Following cessation of therapy, patients were follotheyd for more than 3 years. A patient with melanoma who experienced a prolonged partial regression follotheyd by tumor recurrence received reinduction therapy. |
| Primary End Point: | objective tumor regressions off therapy, and test the hypothesis that reinduction therapy for late tumor recurrence can be effective. |
| Secondary End Point: | NA |
| Patients Number: | 3 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | A patient with colorectal cancer experienced a complete response, which is ongoing after 3 years. A patient with renal cell cancer experienced a partial response lasting 3 years off therapy, which converted to a complete response, which is ongoing at 12 months. A patient with melanoma achieved a partial response that was stable for 16 months off therapy; recurrent disease was successfully treated with reinduction antiPD1 therapy. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | These data represent the most prolonged observation to date of patients with solid tumors responding to antiPD1 immunotherapy and the first report of successful reinduction therapy following delayed tumor progression. They underscore the potential for immune checkpoint blockade with antiPD1 to reset the equilibrium bettheyen tumor and the host immune system. |