New draft guidance from NICE recommends that pembrolizumab with carboplatin and paclitaxel or nab-paclitaxel should be made available as a treatment option for untreated metastatic squamous non-small cell lung cancer (NSCLC) through the Cancer Drugs Fund. NICE recommends that pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if there is disease progression.
The main clinical evidence for pembrolizumab with carboplatin and paclitaxel (pembrolizumab combination therapy) comes from the ongoing randomised controlled KEYNOTE-407 trial, which compares pembrolizumab combination therapy with placebo plus carboplatin and paclitaxel or nab-paclitaxel in adults with untreated advanced or metastatic squamous NSCLC with an Eastern Cooperative Oncology Group performance status of 0 or 1.
At the most recent data-cut (April 2018), median overall survival was 15.9 months for pembrolizumab combination therapy and 11.3 months for standard chemotherapy (hazard ratio [HR] 0.64; 95% CI 0.49-0.85). Median progression-free survival was 6.4 months and 4.8 months, respectively (HR 0.56; 95% CI 0.45-0.70). Median overall survival was not reached in KEYNOTE-407 for the subgroups with a PD-L1 tumour proportion score of 50% or higher, in either arm.
Because the clinical evidence is immature, the cost-effectiveness estimates for pembrolizumab combination therapy remain very uncertain. There is also uncertainty about whether the combination therapy would meet the criteria for being considered a life-extending treatment at the end of life when compared with standard chemotherapy.
The NICE appraisal committee agreed that, with longer follow-up data from KEYNOTE-407, the combination therapy has the potential to be cost-effective, and should be considered for inclusion in the Cancer Drugs Fund.
The draft decision is open to appeal until 5 pm, 22 August 2019.