A Phase III randomized study comparing nivolumab treatment with docetaxel chemotherapy, presented at at the 2015 meeting of the American Society of Clinical Oncology (ASCO; 29 May–2 June, IL, USA) this weekend, has highlighted the PD-1-targeting immunotherapy agent as a potentially effective treatment for patients with nonsquamous non-small-cell lung cancer (NSCLC) who have previously been treated.
Study results indicated that patients with advanced disease who deteriorated following platinum-based chemotherapy lived on average 3 months longer when treated with nivolumab, compared with those who received docetaxel chemotherapy.
“This is the first Phase III study to show that immunotherapy is effective against non-squamous-cell NSCLC, and appears to be particularly active in patients with PD-L1-positive tumors,” explained lead study author Luis Paz-Ares (Hospital Universitario 12 de Octubre; Madrid, Spain).
The trial randomly assigned 582 patients with advanced non-squamous NSCLC to receive therapy with either nivolumab or docetaxel. Both response rates and median overall survival were found to be higher in the nivolumab group in comparison with the docetaxel group (19.2% vs 12.4%; 12.2 months vs 9.4 months, respectively). In addition, responses lasted significantly longer in the nivolumab group (17.1 months vs 5.6 months, on average).
Notably, the benefits of nivolumab were most heightened for patients exhibiting high levels of PD-L1 in their tumors. Although overall, patients receiving nivolumab had a 27% lower risk of death in comparison with those who received docetaxel, patients with high tumor PD-L1 levels (≥1% cells) had a 41–60% reduction in risk of death, which was unseen in patients with low or undetectable levels of PD-L1. Median survival in patients with high PD-L1 levels was also >17 months with nivolumab as opposed to 9 months for those treated with docetaxel.
Paz-Ares further commented: “While nivolumab appears to be more potent against this most common lung cancer, it is important to note that it is also far easier on patients compared to the standard second-line treatment, docetaxel.”
Adverse effects were reduced in the nivolumab arm, with only one in ten patients experiencing serious effects, compared with >50% of those receiving docetaxel. Additionally, 4.9% and 14.9% of patients in the nivolumab arm and the docetaxel arm, respectively, ended treatment due to toxic side effects, with approximately half of these patients subsequently receiving systemic therapy. There was one treatment-related death in the docetaxel arm and none with nivolumab.
The research team believes that nivolumab could become a new standard therapy for patients who have previously been treated for NSCLC. This was supported by other experts at ASCO, including Gregory A Masters from the Helen F Graham Cancer Center (DE, USA): “Even 5 years ago, an effective immunotherapy for lung cancer was largely considered impossible. Today, we have such a treatment, and it surpasses the standard therapy both in terms of efficacy and patient quality of life.”