Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial

This prespecified exploratory analysis (n=299) found that pembrolizumab led to both better health-related quality-of-life scores and longer time to deterioration in symptoms of cough, dyspnoea, and chest pain compared with those for platinum-based chemotherapy.

A commentary notes that from a methodological point of view, the analysis, presentation, and interpretation of the clinical relevance of quality of life (QOL) data is not easy, particularly in an advanced-disease setting in which the proportion of missing questionnaires is not negligible due to disease progression and worsening of patients' conditions. It adds that given that the primary results of the trial showing superior efficacy and lower toxicity of pembrolizumab compared with platinum-based chemotherapy, the significant improvement in global QOL favouring pembrolizumab is not surprising. Furthermore, these data will allow a more complete definition of benefits and harms associated with the different treatments available for these patients, alongside the efficacy and safety data of the trial. The commentator points out that a delay between the publication of primary endpoint results and QOL analysis is common for many trials, but the availability of QOL data, along with the primary results would allow a timely evaluation of the benefit-to-risk ratio and of the value of the treatment. He alludes to the recent update of ASCO clinical practice guidelines that includes a strong recommendation that, in the absence of contraindications to immune checkpoint therapy, single-agent pembrolizumab should be the standard treatment for patients with either non-squamous or squamous NSCLC and high PD-L1 expression, and suggests these QOL data “reinforce the evidence supporting pembrolizumab as first-line treatment in advanced NSCLC with expression of PD-L1 on at least 50% of tumour cells.”