Some 19.1% on pembrolizumab responded to treatment compared to 34.9% on standard chemotherapy. Overall survival was significantly longer with pembrolizumab (12.3 months) compared to standard care (10.3 months, HR 0.78, p=0.0086). The results were similar in patients with a lower cut point of PD-L1 expression (CPS >1). “Patients with PD-L1 expression live longer when they have initial treatment with pembrolizumab,” said first author Prof Barbara Burtness, Yale School of Medicine and Co-Director, Development Therapeutics Research Program, Yale Cancer Center, New Haven, US. There was no difference in progression-free survival between groups (HR 0.99, 95% confidence interval 0.75–1.29). Median response duration was longer with pembrolizumab (20.9 months) than standard therapy (4.5 months).
Some 23.3% responded to pembrolizumab and 36.1% responded to standard treatment. In patients with tumour and/or surrounding cells expressing PD-L1 (combined positive score >20), overall survival was significantly longer with pembrolizumab (14.9 months) than standard treatment (10.7 months, hazard ratio 0.61, p=0.0007). The patient demographics and disease characteristics were similar between the treatment arms. In the first comparison, 301 patients received pembrolizumab and 300 patients had standard treatment, with median follow up of 11.7 and 10.7 months, respectively. Patients were randomly allocated in a 1:1:1 ratio to: 1) standard treatment with platinum-based chemotherapy (5-FU with cisplatin or carboplatin) and cetuximab (the control group) 2) pembrolizumab alone or 3) a novel combination of pembrolizumab and platinum-based chemotherapy.Īt ESMO 2018 researchers presented results on pembrolizumab alone compared to standard treatment in patients expressing PD-L1, a marker of immune activity, and on the novel combination compared to standard treatment in all patients regardless of PD-L1 expression. KEYNOTE-048 enrolled patients with head and neck cancer who had not received prior chemotherapy or biologic therapy for recurrent or metastatic disease. The phase III KEYNOTE-048 study examined whether the anti-PD-1 monoclonal antibody pembrolizumab could prolong survival and slow cancer growth compared to standard treatment. Around 35% of patients respond to treatment, which leads to a median survival of just over ten months.
#Keynote 048 results plus#
The current standard treatment for metastatic or recurrent head and neck cancer is platinum-based chemotherapy (5-fluorouracil (5-FU) with cisplatin or carboplatin) plus the EGFR inhibitor cetuximab. MUNICH, Germany – Immunotherapy with pembrolizumab improves survival in patients with head and neck cancer that has recurred or metastasised, according to late-breaking results from the KEYNOTE-048 study reported at the ESMO 2018 Congress in Munich.
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