Immunotherapies Opdivo Inj. and Keytruda Inj. showed excellent efficacy and safety in a real-world setting, government data showed.
The Health Insurance Review and Assessment Service (HIRA) announced the result of “Post-Assessment Study of Immune Checkpoint Inhibitors” and released detailed data on HIRA’s website on Tuesday. HIRA commissioned the study to the Korean Cancer Study Group in December.
The insurance review agency had notified that it would carry out a post-assessment study when it granted the first reimbursement for immune checkpoint inhibitors in August 2017.
The study was on Opdivo (nivolumab) and Keytruda (pembrolizumab) to evaluate their safety and efficacy in patients with progressive or metastatic non-small cell lung cancer who failed in the standard platinum-based chemotherapy.
The study was retrospective, multi-center, based on local real-world data. The researchers selected 1,181 patients at top 20 hospitals that had the most patients based on reimbursement claims for immune checkpoint inhibitors from August 2017 to June 2018.
The result showed that the two immunotherapies’ clinical effectiveness and safety were similar to or somewhat stronger than those revealed in large-scale, prospective, phase-3 trials in the past, in terms of objective response rate (ORR) and progression-free survival (PFS).
ORR, seen in tumor size reduction, rose 33.6 percent. PFS, or the length of time during and after the treatment of cancer that a patient lives with the disease, but it does not get worse, was 5.13 months. The overall survival was 10.23 months.
About 48 percent of the patients had six-month PFS, and 46.47 percent, one-year PFS.
Considering 163 patients (156 died, and 133 among them died within 90 days) who were not available for the evaluation of ORR, however, the ORR goes down to 28.95 percent.
According to the analysis of Korean-made potential biomarker that predicts the efficacy of a drug, patients with old age, high stage of a malignant tumor (TNM stage), and those accompanying bone or brain metastases had shorter survival. Patients with immune-mediated side effects survived longer than those without such side effects.
Also, patients with over 50 percent of programmed death-ligand 1 (PD-L1) had longer PFS.
The researchers said epidermal growth factor receptor (EGFR) mutation was related to the reduction of PFS, suggesting that it could be a potential biomarker to predict the disease.