Merck (NYSE:MRK) announces the final analysis of the Phase 3 KEYNOTE-048 clinical trial evaluating KEYTRUDA (pembrolizumab), combined with chemo, for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data are being presented today at ASCO in Chicago.
The combo failed to demonstrate a statistically significant improvement in progression-free survival (PFS) compared to the standard-of-care EXTREME regimen [Eli Lilly’s ERBITUX (cetuximab) + chemo] in patients with PD-L1 expression with Combined Positive Score (CPS) of at least 20 (high expression of PD-L1), although it did extend overall survival (OS) by 3.7 months (14.7 months versus 11.0 months) with 40% less risk of death (hazard ratio = 0.60) in this group.
The was no difference in PFS in the total population between KEYTRUDA monotherapy and the EXTREME regimen.
The company’s U.S. marketing application seeking approval to use KEYTRUDA alone and with chemo to treat HNSCC in a first-line setting is currently under FDA review with an action date of June 10.
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