KEYNOTE-024 three-year survival update: Pembrolizumab effective as first-line therapy for advanced non-small-cell lung cancer
First line Pembrolizumab ( Keytruda ) monotherapy provides durable long-term overall survival benefit compared to chemotherapy, according to data presented at the IASLC 2019 World Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer.
Investigators had previously presented preliminary data on KEYNOTE-024 and they are now sharing three years' worth of data on these patients.
In the phase III KEYNOTE-024 trial, first-line Pembrolizumab significantly improved progression free survival and overall survival compared with Platinum-based chemotherapy in patients with advanced non-small cell lung cancer with a PD-L1 tumor proportion score of equal to or greater than 50%, and no targetable EGFR/ALK alterations.
Patients were randomized to Pembrolizumab 200 mg for two years or Platinum doublet for four to six cycles plus optional maintenance ( nonsquamous ), with stratification by Eastern Cooperative Oncology Group score of 0 or 1, tumor histology ( squamous / nonsquamous ), and region ( East Asia /non-East Asia ).
Patients in the chemotherapy arm could cross over to Pembrolizumab upon disease progression if they met eligibility criteria.
The primary endpoint was progression-free survival and overall survival ( OS )was a key secondary endpoint.
The median overall survival length among patients in the Pembrolizumab arm was 26.3 months compared to 14.2 months in the chemotherapy arm.
The 36-month overall survival rate was 43.7% in the Pembrolizumab arm vs 24.9% in the chemotherapy arm.
Despite longer mean treatment duration in the Pembrolizumab arm ( 11.1 vs 4.4 months ), grade 3-5 treatment-related adverse events were less frequent with Pembrolizumab vs chemotherapy.
Initial results showed in addition activity for a re-exposure to Pembrolizumab for those patients, who had progressed after having received two years of treatment with Pembrolizumab with a response in 7 out of 10 patients ( 70% ).
In conclusion, with more than three years' follow-up, first-line Pembrolizumab monotherapy continued to provide durable long-term overall survival benefit versus chemotherapy despite a majority of patients assigned to chemotherapy crossing over to Pembrolizumab.
Pembrolizumab was associated with less toxicity than chemotherapy.
Patients who completed 35 cycles of pembrolizumab had durable clinical benefit and most were alive at data cutoff. ( Xagena )
Source: International Association for the Study of Lung Cancer ( IASLC ), 2019