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UK's NICE Recommends Keytruda Plus Chemo for Upfront NSCLC, Regardless of PD-L1 Expression

NEW YORK – The UK's National Institute for Health and Care Excellence published a draft guidance on Thursday recommending Merck's PD-1 inhibitor pembrolizumab (Keytruda) combined with pemetrexed and platinum-based chemotherapy as a first-line treatment for advanced non-small cell lung cancer patients regardless of PD-L1 expression status.

The pembrolizumab-chemotherapy combination, evaluated in Merck's Keynote-189 trial, is specifically indicated for patients whose tumors do not harbor EGFR mutations or ALK rearrangements. The guidance, which NICE expects to finalize next month, will make the treatment routinely available for this patient subset within the UK's National Health Service.

According to NICE, a course of treatment has a list price of £5,260 ($7,186) but will be available to the NHS at an undisclosed discount.

The pembrolizumab-chemotherapy regimen was previously available to NSCLC patients in the UK through a Cancer Drugs Fund managed access agreement, which required that Merck collect additional data to determine whether the treatment should be available for routine use. The data collected through the CDF suggested that NSCLC patients who received the pembrolizumab plus chemo regimen for up to two years will likely live longer than those on just pemetrexed and platinum chemotherapy.

NICE also noted in its guidance that although the regimen will be available to patients regardless of their tumor PD-L1 expression levels, combining pembrolizumab with chemotherapy has not been shown to offer an overall survival advantage over pembrolizumab monotherapy in patients whose tumors specifically express PD-L1 in 50 percent or more of their tumor cells. In these PD-L1-high patients, single-agent pembrolizumab is routinely prescribed.

The US Food and Drug Administration has also approved pembrolizumab with pemetrexed and platinum chemo in first-line NSCLC regardless of patients' PD-L1 status.