Head and neck cancer: pembrolizumab improved outcome for some
Immunotherapy with the checkpoint inhibitor pembrolizumab may be a better option than standard treatments for patients whose head and neck cancer has spread, or recurred after an initial round of chemotherapy, according to results of the Keynote-040 trial presented at the ESMO 2017 Congress in Madrid.
Although the 19% improvement in overall survival among patients treated with pembrolizumab did not meet the prespecified difference for statistical significance, it was nevertheless a clinically meaningful difference for this population who only lived seven to eight months, on average, after initiating treatment, said lead investigator Dr. Ezra Cohen, from the University of California, San Diego Moores Cancer Center, in La Jolla, California.
»Even though the study did not meet its primary endpoint, I still think it is a positive trial,” he said. »It reinforces that pembrolizumab should continue to be offered as an important option for all patients with this devastating disease.”
The KEYNOTE-040 trial was a global, open-label, phase 3 study which included patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after a platinum-based chemotherapy. Patients were randomised to receive either pembrolizumab (n=247) or standard of care (SOC) treatment (n=248), which was the investigator’s choice of either methotrexate, docetaxel, or cetuximab.
Median overall survival (OS) was only marginally higher in the pembrolizumab compared to standard treatment arm (8.4 versus 7.1 months, hazard ratio [HR] 0.81 95% CI 0.66-0.99, P= .0204), however for a subset of patients who had PD-L1-expressing tumours, pembrolizumab was associated with dramatic and significantly improved outcomes.
Specifically, among patients with PD-L1-expression in more than 1% of all cells in their tumour, median OS was 8.7 months with pembrolizumab versus 7.1 months with standard treatments (HR 0.75; 95% CI 0.59-0.95, P=.0078), and among patients with PD-L1-expression in more than 50% of their cancer cells, median OS was 11.6 versus 7.9 months respectively (HR 0.54; 95% CI 0.35-0.82, P=.0017).
Compared to the other treatments, pembrolizumab measured up well in terms of side-effects.
»In almost every category it had a better side-effect profile, meaning a lower incidence of toxicity, versus standard treatments,” said Cohen. »The exception is hypothrodism, which occurred in 13% of those treated with pembro versus only 1% of those given other treatments.”
# LBA45_PR Cohen EE et al: 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
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