Merck's Keytruda faces NICE pushback as Ibrance, Lynparza grab green lights

Merck & Co. was dealt a blow earlier this month after I-O superstar Keytruda missed its mark in a key late-stage trial for small-cell lung cancer, stripping the chance at a major label expansion. Now, in head and neck cancer, Keytruda is facing pushback from England's cost watchdog. 

The National Institute for Health and Care Excellence's (NICE) appraisal committee chose not to recommend Keytruda's placement on England's NHS as a first-line-or-later treatment for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 

The Keytruda setback was one of several cancer drug assessments NICE released this week. It wasn't the only rejection, either; Astellas' Xospata also was turned back, while Pfizer's Ibrance, and AstraZeneca and Merck's Lynparza picked up backing for new uses.

On the Keytruda front, the committee raised concerns that the pivotal trial's design didn't reflect treatment protocols for HNSCC patients on the NHS, where therapy is determined by whether the cancer started in the mouth. Because the control arm of the study didn't match up to NHS practice, the committee argued Keytruda's results in that trial may not apply in Britain.

With draft guidance expected Feb. 12, the committee directed NICE to send a list of questions to Merck in anticipation of a final decision, including asking for more detailed clinical data and cost-effectiveness information.

RELATED: Merck's Keytruda misses key mark in small cell lung cancer trial, dashing big expansion hopes