In a nutshell
This trial examined the effectiveness of combining the targeted therapy drug pembrolizumab (Keytruda) with chemotherapy at treating certain types of advanced non-small-cell lung cancer. The trial concluded that this combination is more beneficial than chemotherapy alone for treating this subset of patients.
Some background
PD-1 inhibitors, such as pembrolizumab, are drugs that target the PD-L1 protein which may be involved in lung cancer growth. Pembrolizumab has now replaced chemotherapy as first line treatment for patients with a high level of PD-L1. Early studies indicate that combining PD-1 inhibitors with platinum-based chemotherapy may be more beneficial at treating advanced NSCLC.
Methods & findings
This study examined the benefit of combining pembrolizumab with chemotherapy for treating advanced NSCLC. The study included a total of 616 patients, who were randomly assigned into two groups. Both groups received chemotherapy. The treatment group included 410 patients who were also treated with pembrolizumab. The other group of 206 patients received a placebo (substance with no active effect). Patients were followed for an average of 10.5 months.
The estimated percentage of patients to survive at 12 months was 69.2% for the treatment group and 49.4% for the placebo group. This increased survival was seen even in patients with low levels of PD-L1.
Average progression free survival (PFS, time from beginning trial until disease progression) was 8.8 months for the treatment group compared to 4.9 months for the placebo group. The estimated percentage of patients without disease progression at 12 months was 34.1% for the treatment group and 17.3% for the placebo group.
The response rate (RR, percentage of patients with a complete or partial reduction in tumor size) was 47.6% for the treatment group and 18.9% for the placebo group.
Adverse side effects grade 3 (severe) or higher occurred in 67.2% of the treatment group and 65.8% of the placebo group. 6.7% of patients in the treatment group died due to side effects compared to 5.9% in the placebo group. The most common side effects in both groups were nausea, anemia and fatigue. Diarrhea and rash were more common in the treatment group.
The bottom line
The authors concluded that combining pembrolizumab with chemotherapy is more beneficial at treating patients with advanced NSCLC without specific genetic mutations.
The fine print
This trial was funded by the manufacturers of pembrolizumab.
Published By :
The New England Journal of Medicine
Date :
Apr 16, 2018