- 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.
- #ASCO19