| General information |
| Database: | DB00168 |
| Objective: | They report overall survival (OS), response durability, and longterm safety in patients with non small cell lung cancer (non small cell lung cancer) receiving nivolumab in this trial. |
| Authors: | Gettinger SN, et al |
| Title: | Overall Survival and LongTerm Safety of Nivolumab (AntiProgrammed Death 1 Antibody, BMS936558, ONO4538) in Patients With Previously Treated Advanced non small cell Lung Cancer. |
| Journal: | J Clin Oncol |
| Year: | 2015 |
| PMID: | 25897158 |
| Trial Design |
| Clinical Trial Id: | NCT00730639 |
| Agent: | nivolumab
|
| Target: | PD1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I doseescalation cohort expansion trial |
| Key Patients Feature: | Patients had a median age of 65 years, and 98% had an ECOG performance status of 0 or 1; 42% and 57% had squamous and nonsquamous non small cell lung cancer, respectively |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Pts received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8week cycles for up to 96 weeks. Tumor burden was assessed by RECIST (version 1.0) after each cycle. |
| Primary End Point: | overall survival (OS) outcomes. |
| Secondary End Point: | response duration and the longterm safety profile |
| Patients Number: | 129 |
| Trial Results |
| DLT_MTD: | the maximumtolerated dose was not reached at the highest planned dose of 10 mg/kg. |
| Objective Response Rate: | Among 22 patients (17%) with objective responses, estimated median response duration was 17.0 months. An additional six patients (5%) had unconventional immunepattern responses. Response rates were similar in squamous and nonsquamous non small cell lung cancer. Eighteen responding patients discontinued nivolumab for reasons other than progressive disease; nine (50%) of those had responses lasting > 9 months after their last dose. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Median OS across doses was 9.9 months; 1, 2, and 3year OS rates were 42%, 24%, and 18%, respectively, across doses and 56%, 42%, and 27%, respectively, at the 3mg/kg dose (n = 37) chosen for further clinical development. |
| Adverse Event(agent arm): | Grade 3 to 4 treatmentrelated adverse events occurred in 14% of patients. Three treatmentrelated deaths (2% of patients) occurred, each associated with pneumonitis. |
| Conclusions: | Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated non small cell lung cancer. Randomized clinical trials with nivolumab in advanced non small cell lung cancer are ongoing. |