NICE has approved pembrolizumab with pemetrexed and platinum chemotherapy for use within the Cancer Drugs Fund, as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations.
The decision is based on data from the ongoing phase 3 KEYNOTE-189 trial of pembrolizumab combined with pemetrexed/platinum chemotherapy versus pemetrexed/chemotherapy alone.
At the most recent data cut-off date (November 2017), median overall survival (OS) for pembrolizumab combination had not been reached. The results showed a large difference in OS at 12 months (69.2% with pembrolizumab combination vs 49.4% with standard care). The results were consistent regardless of tumour proportion score (TPS).
The NICE advisory committee said the short follow-up period (median 10.5 months) made it difficult to know if pembrolizumab combination would continue to have a large benefit on overall survival in the long term. The uncertainty about the long-term benefit of the treatment led to similar uncertainty around cost-effectiveness.
Pembrolizumab combination was found to meet NICE's criteria for life-extending end-of-life treatment compared with standard care and chemotherapy, but did not meet the criteria when compared with pembrolizumab monotherapy.
The advisory committee concluded that pembrolizumab combination has the potential to be cost-effective, but more evidence is needed. “Therefore, pembrolizumab combination is recommended for use in the Cancer Drugs Fund for adults who have untreated, metastatic, non-squamous NSCLC whose tumours have no EGFR- or ALK-positive mutations,” the committee decided.
Because the clinical and cost-effective evidence to date is limited to two years of treatment, the use of pembrolizumab is limited to two years of uninterrupted treatment or less if the disease progresses.
