Pembrolizumab Superior to Standard of Care in SCC

A recent trial looked to compare the efficacy and safety of pembrolizumab (Keytruda) with the standard of care for the treatment of head and neck squamous cell carcinoma (SCC).

Researchers conducted a randomized, open-label, phase 3 study across 97 medical centers in 20 different countries. The trial enrolled patients with SCC whose disease had progressed during or after platinum-containing treatment for recurrent or metastatic disease (or both), or patients whose disease recurred or progressed within 3 to 6 months of previous multimodal therapy containing platinum for locally advanced disease. Patients were then randomized 1:1 to receive pembrolizumab 200 mg every 3 weeks or investigator’s choice of standard doses of methotrexate, docetaxel, or cetuximab (standard of care group).

The trial enrolled 495 patients, of whom 247 were randomized to receive pembrolizumab every 3 weeks and 248 were randomized to receive the standard of care. Researchers found that 37% of patients taking pembrolizumab survived for at least 1 year, compared with 26.5% of patients receiving the standard of care. The median overall survival was 8.4 (95% CI, 6.4-9.4) months with pembrolizumab, and 6.9 (95% CI, 5.9-8.0) months with the standard treatment.

The response rates were similar among the 2 groups, at 14.6% in the pembrolizumab group versus 10.1% in the standard of care. The most common treatment-related adverse event was hypothyroidism with pembrolizumab (in 33 [13%] patients) and fatigue with the standard of care (in 43 [18%] patients).

“The clinically meaningful prolongation of overall survival and favorable safety profile of pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma support the further evaluation of pembrolizumab as a monotherapy and as part of combination therapy in earlier stages of disease,” wrote the study authors.

Reference

Cohen E, Soulieres D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): a randomized, open-label, phase 3 study [published online November 30, 2018]. Lancet. doi: 10.1016/S0140-6736(18)31999-8.