Phase III KEYNOTE-024 results for Keytruda (pembrolizumab) show improved progression-free survival in non-small cell lung cancer- Merck Inc

Results of the phase III KEYNOTE-024 trial have been announced, investigating the use of Keytruda (pembrolizumab), from Merck Inc, compared to standard of care with platinum-based chemotherapy in untreated patients with advanced non-small cell lung cancer (NSCLC) and high PD-L1 expression (defined as expression in at least 50% of tumour cells). Patients with EGFR activating mutations and ALK translocations were excluded from recruitment.

The investigators found that pembrolizumab significantly improved the primary endpoint of progression-free survival by approximately four months compared to chemotherapy (10.3 months versus 6.0 months). The secondary endpoint of overall survival was also significantly prolonged, and 80% of patients on pembrolizumab were alive at six months compared to 72% on chemotherapy. Pembrolizumab was associated with a higher overall response rate compared to chemotherapy (45% versus 28%), a longer duration of response, and lower incidences of all and serious (3/4) adverse events. A further study is needed to confirm these findings in patients with high PD-L1 expression. Data were also published in the New England Journal of Medicine. Data were presented at the ESMO 2016 Congress.

Comment: All endpoints of efficacy and tolerability favoured treatment with pembrolizumab, suggesting it should become one standard of care for first line treatment of patients with advanced NSCLC and high PD-L1 expression. It is the first time a therapy has improved progression-free survival over the current standard first line treatment with platinum-based doublet chemotherapy.