Keytruda (pembrolizumab) may be more beneficial than standard therapy for patients whose head and neck cancer has spread or returned after a first round of chemotherapy.
That’s the conclusion of a Phase 3 study, “Pembrolizumab (pembro) vs standard of care (SOC) for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 3 KEYNOTE-040 trial.” that was presented Sept. 11 at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid.
In a population that lives only seven to eight months on average, Keytruda lengthened survival by 1.3 months. While this wasn’t enough for the Phase 3 trial to meet its primary endpoint, Keytruda was safer and more effective than standard therapies, it found.
The Keynote-040 clinical trial (NCT02252042) included patients whose cancer returned after treatment, as well as those with metastatic head and neck squamous cell carcinoma that spread to other parts of the body after platinum-based chemotherapy.
Overall, 495 patients were randomized to receive either Keytruda or one of three other therapies: methotrexate, Taxotere (docetaxel) or Erbitux (cetuximab).
Results showed that Keytruda lengthened survival by 19 percent, from 7.1 months to 8.7 months. However, for patients with PD-L1+ tumors, the outcomes were far better. Among patients with at least 1 percent of cancer cells expressing PD-L1, median overall survival was 8.7 months in the Keytruda arm, and 7.1 month in the control arm — a 25 percent increase. And for patients who had PD-L1 expression in more than 50 percent of their cancer cells, Keytruda increased survival by 46 percent, from 7.9 months to 11.6 months.
Keytruda also performed well with regard to safety and side effects compared to standard-of-care therapies.
Although the 19 percent improvement in overall survival among patients treated with pembrolizumab did not meet the pre-specified requirements, it was still clinically meaningful for this population, for whom life expectancy is merely seven to eight months after initiating treatment, said lead investigator Ezra Cohen of the University of California San Diego.
“Even though the study did not meet its primary endpoint, I still think it is a positive trial,” Cohen said in a press release. “It reinforces that pembrolizumab should continue to be offered as an important option for all patients with this devastating disease.”
Added Amanda Psyrri of the University of Athens Medical School: “Keynote-040 did not reach its primary endpoint of overall survival. However, pembrolizumab was superior to investigator’s choice in terms of toxicity, an important consideration in treatment decisions for these poor-prognosis patients with recurrent/metastatic platinum-refractory HNSCC.”
