New data and a price reduction have helped secure a place for Keytruda on the NHS as a treatment for some patients with lung cancer.
The National Institute for Health and Care Excellence has published new draft guidelines endorsing the drug's use to treat locally advanced or metastatic PD L1-positive non-small-cell lung cancer (NSCLC) in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [ALK] positive tumour).
The guidelines also stipulate that treatment with Keytruda (pembrolizumab) is stopped at two years of uninterrupted treatment and no documented disease progression, and that the company must continue to provide the drug at the discount agreed in the new patient access scheme to ensure its continued cost-effectiveness.
In earlier draft guidance, NICE's appraisal committee had not rejected Keytruda in this setting because of uncertainties surrounding its long term benefits. However, MSD subsequently provided a more recent analysis of trial data and offered a cheaper price for the drug, paving the way to NHS funding in England and Wales.
Around 1,700 people in England are expected to be eligible for treatment with the therapy, which is administered as an injection every three weeks.
Keytruda was approved in Europe for NSCLC back in August based on data from two studies - KEYNOTE-010, which assessed overall survival (OS) and KEYNOTE-001, which looked at overall response rates (ORR) - showed significant improvements in patients taking the drug.
In KEYNOTE-010, both doses significantly improved OS compared with docetaxel; Keytruda resulted in a 29 percent improvement for the 2 mg/kg dose and a 39 percent improvement for the 10 mg/kg dose. Median OS for was 10.4 months and 12.7 months, respectively, compared to 8.5 months for docetaxel.
Among patients with higher levels of PD-L1 expression, OS was superior for both Keytruda doses, improving 46 percent for the lower dose and 50 percent for the higher one compared to docetaxel. Median OS was 14.9 months, 17.3 months and 8.2 months, respectively.
"People with advanced non-small-cell lung cancer have had limited treatment options so it is great that pembrolizumab will now be routinely available," said Professor Carole Longson, director of the NICE centre for health technology evaluation, commenting on the decision.
"If companies work with us to price drugs reasonably and manage any uncertainties in the evidence base, we can continue to recommend patients have routine access to the treatments they need."
The Scottish Medicines Consortium is expected to publish its advice on pembrolizumab in January 2017.
Meanwhile, over in the US, regulators have agreed to undertake a priority review of Merck's application to expand the scope of the drug to refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy.
The application will also be reviewed under the FDA's accelerated approval programme, with action expected by March 15 next year.