| General information |
| Database: | DB00170 |
| Objective: | Nivolumab, a fully human IgG4 programmed death 1 (PD1) immunecheckpointinhibitor antibody, disrupts PD1mediated signaling and may restore antitumor immunity. |
| Authors: | Borghaei H, et al |
| Title: | Nivolumab versus Docetaxel in Advanced Nonsquamous non small cell Lung Cancer. |
| Journal: | N Engl J Med. |
| Year: | 2015 |
| PMID: | 26412456 |
| Trial Design |
| Clinical Trial Id: | NCT01673867 |
| Agent: | nivolumab
|
| Target: | PD1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | nonsquamous non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized, openlabel, internationalphase III study |
| Key Patients Feature: | patients with nonsquamous non small cell lung cancer (non small cell lung cancer) that had progressed during or after platinumbased doublet chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | docetaxel |
| Treatment Info: | pts to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of bodysurface area every 3 weeks. |
| Primary End Point: | overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 292 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rate was 19% with nivolumab versus 12% with docetaxel (P=0.02). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | progression free survival did not favor nivolumab over docetaxel (median, 2.3 months and 4.2 months, respectively), the rate of progression free survival at 1 year was higher with nivolumab than with docetaxel (19% and 8%, respectively). |
| Median OS A vs. C: | The median overall survival was 12.2 months (95% confidence interval [CI], 9.7 to 15.0) among 292 patients in the nivolumab group and 9.4 months (95% CI, 8.1 to 10.7) among 290 patients in the docetaxel group (hazard ratio for death, 0.73; 96% CI, 0.59 to 0.89; P=0.002). At 1 year, the overall survival rate was 51% (95% CI, 45 to 56) with nivolumab versus 39% (95% CI, 33 to 45) with docetaxel. With additional followup, the overall survival rate at 18 months was 39% (95% CI, 34 to 45) with nivolumab versus 23% (95% CI, 19 to 28) with docetaxel. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Among patients with advanced nonsquamous NSCLC that had progressed during or after platinumbased chemotherapy, overall survival was longer with nivolumab than with docetaxel. |