The researchers also assessed the 6-gene IFN-γ signature (IDO1
) with the Nanostring nCounter platform using RNA extracted from FFPE tumor tissue collected prior to treatment. The IFN-γ 6-gene signature score was significantly (P
<.001) associated with response in the 150 available samples. The signature was also associated with improved PFS and OS.
In April 2016, the FDA granted granted a priority review designation to pembrolizumab as a treatment for patients with recurrent or metastatic HNSCC following a platinum-based chemotherapy. Under the Prescription Drug User Fee Act, the FDA is scheduled to make an approval decision by August 9, 2016.
- Chow L QM, Mehra R, Haddad RI. Biomarkers and response to pembrolizumab (pembro) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). J Clin Oncol 34, 2016 (suppl; abstr 6010).
- Mehra R, Seiwert TY, Mahipal A, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012. J Clin Oncol 34, 2016 (suppl; abstr 6012).