Nivolumab and pembrolizumab have been covered in South Korea for mNSCLC as 2nd line or subsequent for PD-L1 expression more than 10% and 50% respectively. The lack of robust evidence makes it challenged for HIRA to identify to which extent benefit standard could be taken as the best to ensure patient access to needed medicines. In that circumstance drug authorizations have been added and HIRA need evidence for expanding reimbursement.
This study is to investigate nivolumab, pembrolizumab efficacy and possible side effects for mNSCLC patients. Efficacy and adverse event data were collected through patient medical chart trying to find factors for patients have better efficacy and survical results.
In total, 1018 out of 1181 patients got response rate and the rest 163 patients couldn't. 1181 patients, No. of treatment was 10.5 and 7.9 for nivolumab and pembrolizumab separately and Duration of treatment (DOT) was 99.9 and 88.9 days. 1018 patients who could get RR, No. of treatment was 9.9 and DOT was 168.7 days. For 163 patients who could not get RR, No. of treatment was 1.4 and DOT was 8.0 days. For 1018 patients, objective RR was 33.6%. Considering 156 of 163 patients died (133 died within 90 days), almost of 163 might be no response. When it comes to considering all patients include 163 patients, RR could be 29%. 163 had differences comparing all patients. They were older (69 vs. 67), had poor performance status (ECOG 2 or more 29% vs. 11%) and liver meta (22.7% vs. 11.8%) and were poor RR of previous therapy. Factors associated with response were Smoking (+), Previous RT (-), irAE(+) and PD-L1 over 50%(+), for OS were PS(+), EGFR(-), Previous RT(-) and irAE(+) and for PFS were stage(-), EGFR(-), Previous RT(-) and irAE(+).
This study's clinical benefit and toxicity for mNSCLC were comparable to those of clinical trials, although population tended to be more heavily treated and have poorer performance status. A favorable outcome could be expected in patients accompanying irAE during immunotherapy and unfavorable in patients who got previous RT. Reimbursement's PD-L1 criteria might be rational according to this study but need further study and analysis.
HIRA.
Has not received any funding.
The author has declared no conflicts of interest.