Draft guidance published today by the cost-effectiveness watchdog says that a regimen based on the checkpoint inhibitor plus carboplatin and paclitaxel should now be a treatment option for previously-untreated adults with squamous NSCLC that has spread to other parts of the body.
NICE stopped short of approving it for routine NHS prescribing, but acknowledged that trials of Keytruda (pembrolizumab) plus chemotherapy suggest people taking the regimen could live longer than those who have standard chemotherapy alone.
The clinical evidence is however immature, it says, and that means the cost-effectiveness estimates for the combination are “very uncertain,” according to NICE. Keytruda and chemotherapy should be stopped after two years of uninterrupted treatment, or earlier if disease progresses, says the draft guidance.
The decision is based on ongoing data from the KEYNOTE-407 trial, which found that the combination improved overall survival in metastatic squamous NSCLC – regardless of PD-L1 tumour expression levels – by almost 16 months, compared to just over 11 months with the chemotherapy on its own.
When further data from the study is available it could be that Keytruda transitions from the CDF to routine NHS use. NICE says around 7,500 people in England are diagnosed each year with this type of lung cancer, and of these around 1,700 may be eligible for Keytruda combination therapy.
Last year, the agency also backed the use of Keytruda with pemetrexed and platinum chemotherapy – once again via the CDF – for untreated adults with non-squamous NSCLC, an indication that has around 3,000 eligible patients…