AIHTA - Publications - Search - Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer

Nachtnebel, A. and Ujeyl, M. (2015): Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer. DSD: Horizon Scanning in Oncology 53.

[thumbnail of DSD_HSO_Nr.53.pdf]
PDF - Sie müssen einen PDF-Viewer auf Ihrem PC installiert haben wie z. B. GSview, Xpdf oder Adobe Acrobat Reader

Nivolumab is the first immunotherapy medicine licensed in the European Union for the treatment of squamous-cell non-small cell lung cancer (NSCLC). Based on the findings of the CheckMate 017 trial, nivolumab received market authorisation for previously treated patients with squamous NSCLC in July 2015.
This open-label phase III study compared nivolumab with docetaxel in a total of 272 patients with squamous-cell NSCLC who had previously been treated with one platinum-containing regimen Median. Overall survival (the primary outcome of this phase III trial) was increased by 3.2 months in the nivolumab group in comparison to the docetaxel group, resulting in a reduction of risk of death by 41%. With 38%, the risk of progression or death was also statistically lower, leading to a gain in median progression-free survival by 0.7 months. Duration of response was not yet reached in the nivolumab group and was 8.4 months in the docetaxel group. Response rates also favoured the PD-L1 inhibitor (20% vs 9%), with the majority being partial responses (19% vs 9%).
In terms of safety outcomes, treatment-related adverse events (AEs) were less frequent in the nivolumab group than in the chemotherapy group. Any-grade AEs occurred in 58% in the nivolumab group in comparison to 86% in the docetaxel group, and grade 3 or 4 AEs in 7% and 55% respectively.
Overall, improved outcomes in all assessed endpoints were demonstrated in the CheckMate 017 trial, with fewer AEs in comparison to standard second-line chemotherapy. Nonetheless, high costs are incurred, data for patient-reported outcomes have not been published yet and long-term adverse effects of immune therapies are unknown.

Item Type:DSD: Horizon Scanning in Oncology
Keywords:Nivolumab, NSCLC, non-small cell lung cancer, bronchial carcinoma, immunotherapy, PD-L1, Nivolumab BMS,
Subjects:WB Practice of medicine > WB 300-962 Therapeutics
QZ Pathology > QZ 200-380 Neoplasms.Cysts
WF Respiratory system
QV Pharmacology, toxicology, pharmacy > QV 60-370 Pharmacology
Series Name:DSD: Horizon Scanning in Oncology 53
Deposited on:31 Aug 2015 16:16
Last Modified:15 Jul 2020 17:53

Repository Staff Only: item control page