Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non–Small-Cell Lung Cancer: Results From the CA209-003 Study

Abstract

Purpose In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non-small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors. Patients and Methods Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method. Results The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had ≥ 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up. Conclusions Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.

Model‐Based Population Pharmacokinetic Analysis of Nivolumab in Chinese Patients With Previously Treated Advanced Solid Tumors, Including Non–Small Cell Lung Cancer

“…The phase 1/2 open‐label CheckMate 077 study investigated the use of nivolumab, including 3 mg/kg and 240 mg Q2W, in Chinese patients with previously treated advanced or recurrent solid tumors, comprising NSCLC, hepatocellular carcinoma, and nasopharyngeal carcinoma (NPC) . In this study, nivolumab was well tolerated, and its pharmacokinetic (PK) profile in Chinese patients was similar to that previously reported in a US population . The open‐label, randomized, phase 3 CheckMate 078 study evaluated nivolumab 3 mg/kg Q2W versus docetaxel 75 mg/m 2 every 3 weeks in a predominantly Chinese patient population with advanced or metastatic NSCLC (squamous or nonsquamous) and disease progression during or after 1 prior platinum‐based doublet chemotherapy regimen.…”

Retrospect and Prospect for Lung Cancer in China: Clinical Advances of Immune Checkpoint Inhibitors

“…The latest articles and abstracts published in the 2018 ASCO annual meeting have reported a series of recent results on the advances of immune checkpoint inhibitors in lung cancer. Focusing on immune checkpoint inhibitor monotherapy, 5‐year follow‐up results from the CA209‐003 study ( n = 129) showed promising long‐term OS and durable responses in a proportion of patients with pretreated advanced NSCLC receiving nivolumab treatment . The estimated 5‐year OS rate was 16% for all nivolumab‐treated patients.…”

Combined targeted DNA and RNA sequencing of advanced NSCLC in routine molecular diagnostics: Analysis of the first 3,000 Heidelberg cases

“…2 Significant advances during the last years were the advent of targeted therapies, i.e. 4 Identification of NSCLC patients likely to profit from these novel therapies relies on the detection of specific biomarkers in tumor biopsies. 4 Identification of NSCLC patients likely to profit from these novel therapies relies on the detection of specific biomarkers in tumor biopsies.…”