Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy

Lung Cancer. 2018 Aug:122:234-242. doi: 10.1016/j.lungcan.2018.05.023. Epub 2018 May 24.

Abstract

Objectives: To investigate the efficacy and safety of nivolumab in Korean patients with stage IIIB/IV or recurrent non-small-cell lung cancer (NSCLC) who failed platinum-based chemotherapy.

Materials and methods: In this multicenter, open-label, Phase II study, 100 patients with stage IIIB or IV squamous (n = 44) or non-squamous (n = 56) NSCLC received nivolumab 3 mg/kg every 2 weeks for 6 weeks per treatment cycle. Patients continued treatment until disease progression or intolerable adverse events (AEs), and then entered a follow-up phase. The primary efficacy endpoint was the centrally assessed objective response rate (ORR).

Results: The ORR was 20.0% (95% confidence interval [CI]: 13.3-28.9%) in the total population, 15.9% (7/44 patients; 95% CI: 7.9-29.4%) in patients with squamous NSCLC, and 23.2% (13/56 patients; 95% CI: 14.1-35.8%) in patients with non-squamous NSCLC. Median overall survival was 13.9 (95% CI: 10.8-18.5) months in the total population, 12.3 (95% CI: 8.2-18.5) months in squamous NSCLC, and 16.3 (95% CI: 10.8, -) months in non-squamous NSCLC. Median progression-free survival was 2.8 (95% CI: 1.4-5.7), 2.6 (95% CI: 1.3-5.7), and 5.3 (95% CI: 1.4-7.1) months in the total, squamous, and non-squamous NSCLC populations, respectively. The median duration of response was 11.7 (95% CI: 5.6, -), 12.0 (95% CI: 4.8, -), and 12.1 (95% CI: 3.0, -) months in the total, squamous, and non-squamous NSCLC populations, respectively. The most frequent AEs were decreased appetite, dyspnea, and cough in 43 (43.0%), 32 (32.0%), and 29 (29.0%) patients, respectively. The most common Grade ≥3 AE was pneumonia, occurring in 7.0% of patients. Common treatment-related AEs included decreased appetite (14.0%) and pruritus (6.0%), neither of which was Grade ≥3.

Conclusion: The efficacy and safety of nivolumab in Korean patients with advanced or recurrent squamous or non-squamous NSCLC are consistent with previous reports.

Keywords: Nivolumab; Non-small cell lung cancer; Programmed cell death-1.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / epidemiology
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Drug Resistance, Neoplasm
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • Follow-Up Studies
  • Humans
  • Korea / epidemiology
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / epidemiology
  • Lung Neoplasms / mortality
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Nivolumab / therapeutic use*
  • Platinum Compounds / therapeutic use
  • Pneumonia / epidemiology*
  • Pneumonia / etiology
  • Prospective Studies
  • Survival Analysis

Substances

  • Antineoplastic Agents
  • Platinum Compounds
  • Nivolumab