Skip to main content
Premium Trial:

Request an Annual Quote

NICE Recommends Keytruda, Chemo Combo for Advanced TNBC, Narrows PD-L1 Expression Threshold

NEW YORK – The National Institute for Health and Care Excellence (NICE) on Wednesday recommended Merck's Keytruda (pembrolizumab) plus chemotherapy for treatment-naïve metastatic triple-negative breast cancer (TNBC) patients in England whose tumors express PD-L1 with a combined positive score of at least 10 and immune cell staining below 1 percent.

The recommendation reverses its preliminary advice in March to the National Health Service England against providing the regimen. At that time, NICE laid out how there was not enough evidence to show that the Keytruda-chemo combination was any more effective than the combination of Roche's Tecentriq (atezolizumab) plus chemo, which is available in England for treatment-naïve metastatic TNBC patients whose tumors express PD-L1 greater than 1 percent by immune cell staining. 

In its latest guidance, NICE recognizes that the PD-L1 expression eligibility criteria for Tecentriq-chemo does not capture all of the patients who could benefit from the immunotherapy combination. Accordingly, NICE decided to recommend Keytruda-chemo for patients with both the combined positive PD-L1 score of at least 10 and immune cell staining below the Tecentriq threshold of 1 percent.

NICE further clarified that the Keytruda regimen is no longer directly comparable to the Tecentriq regimen since the biomarker criteria for these treatments will identify different patient populations and some metastatic TNBC patients who are not eligible for Tecentriq plus chemo could be eligible for Keytruda plus chemo. The lack of a direct comparator removed a "key barrier" to approving Keytruda-chemo, NICE explained.

NICE's independent appraisal committee decided that Keytruda plus chemo meets a threshold of cost-effectiveness for life-extending treatments for people with a short life expectancy.

The recommendation, however, covers a narrower population of patients than those eligible for Keytruda plus chemo in, for example, the US and European Union. In those regions, the treatment regimen is available for patients with the combined positive score of at least 10, rather than those who meet the combined positive score and the immune cell staining threshold.

"Although our recommendation is for a narrower population than pembrolizumab combination is licensed for, it means the maximum number of people with advanced triple-negative breast cancer now have access to effective treatments," Helen Knight, interim director of medicines evaluation at NICE, said in a statement. The updated guidance will likely cover around 100 patients per year, according to a NICE statement.