| General information |
| Database: | DB00167 |
| Objective: | Patients with squamous non small cell lung cancer that is refractory to multiple treatments have poor outcomes. They assessed the activity of nivolumab, a fully human IgG4 PD1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non small cell lung cancer. |
| Authors: | Rizvi NA, et al |
| Title: | Activity and safety of nivolumab, an antiPD1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non small cell lung cancer (CheckMate 063): a phase 2, singlearm trial. |
| Journal: | Lancet Oncol |
| Year: | 2015 |
| PMID: | 25704439 |
| Trial Design |
| Clinical Trial Id: | NCT01721759 |
| Agent: | nivolumab
|
| Target: | PD1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | squamous non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an international, phase II, singlearm trial |
| Key Patients Feature: | patients with advanced, refractory squamous non small cell lung cancer (CheckMate 063) at 27 sites (academic, hospital, and private cancer centres) in France, Germany, Italy, and USA. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients who had received two or more previous treatments received intravenous nivolumab (3 mg/kg) every 2 weeks until progression or unacceptable toxic effects. |
| Primary End Point: | the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee. |
| Secondary End Point: | NA |
| Patients Number: | 117 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 17 (14.5%, 95% CI 8.722.2) of 117 patients had an objective response as assessed by an independent radiology review committee. |
| Disease Control Rate: | Median time to response was 3.3 months (IQR 2.24.8), and median duration of response was not reached (95% CI 8.31not applicable); 13 (77%) of 17 of responses were ongoing at the time of analysis. 30 (26%) of 117 patients had stable disease (median duration 6.0 months, 95% CI 4.710.9). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | 20 (17%) of 117 patients reported grade 34 treatmentrelated adverse events, including: fatigue (five [4%] of 117 patients), pneumonitis (four [3%]), and diarrhoea (three [3%]). There were two treatmentassociated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease. |
| Conclusions: | Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled,phase 3 studies of firstline and secondline treatment. |