KEY TAKEAWAYS
- The KEYNOTE-407 study (NCT02775435) aimed to assess OS and PFS as the two primary endpoints, using a blinded independent central review based on the Response Evaluation.
- Chinese patients from mainland China enrolled in the KEYNOTE-407 global study were randomized in a 1:1 ratio to receive either pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel or placebo plus the same chemotherapy regimen.
- The study concluded that Pembrolizumab plus chemotherapy significantly improved both OS and PFS compared to placebo plus chemotherapy and also supported the using pembrolizumab-chemotherapy, as a 1L treatment option for Chinese patients with metastatic squamous NSCLC.
In the randomized, double-blind, phase 3 KEYNOTE-407 study, pembrolizumab plus chemotherapy significantly improved survival outcomes over placebo plus chemotherapy in patients with previously untreated metastatic squamous NSCLC. Researchers presented the results of Chinese patients enrolled in the global and China extension investigations of KEYNOTE-407.
Patients enrolled in the KEYNOTE-407 global (NCT02775435) and China extension (NCT03875092) studies from mainland China have randomized 1:1 to 35 cycles of pembrolizumab or placebo plus four cycles of carboplatin and paclitaxel or nab-paclitaxel. Overall survival (OS) and progression-free survival (PFS) were the two primary endpoints (based on the Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review). Randomization was performed on 125 patients (pembrolizumab-chemotherapy, n = 65; placebo-chemotherapy, n = 60). The median (range) duration of study follow-up as of September 30, 2020, was 28.1 (25.140.9) months. Pembrolizumab-chemotherapy was superior to placebo-chemotherapy in terms of OS (hazard ratio [HR] = 0.44, 95% confidence interval [CI]: 0.28-0.70) and PFS (HR = 0.35, 95% CI: 0.24-0.52). Compared to placebo chemotherapy, the two-year OS and PFS rates for pembrolizumab-chemotherapy were 56.9% versus 31.7% and 24.2% versus 3.3%, respectively. 81.5% and 81.7% of patients experienced treatment-related adverse events in grades 3 to 5. Compared to placebo-chemotherapy, pembrolizumab-chemotherapy improved global health status/quality of life scores at week 18 (difference in the least squares means = 7.6, 95% CI: 1.5-13.7) and prolonged time to deterioration in cough, chest pain, or dyspnea (HR = 0.50, 95% CI: 0.28-0.89). Pembrolizumab-chemotherapy prolonged survival compared to placebo-chemotherapy in Chinese patients with metastatic squamous NSCLC, with tolerable toxicity and preserved or enhanced health-related quality of life. These results supported using pembrolizumab-chemotherapy as a first-line treatment in this population. The study concluded that Pembrolizumab plus chemotherapy significantly improved both OS and PFS compared to placebo plus chemotherapy and also supported the using pembrolizumab-chemotherapy, as a 1L treatment option for Chinese patients with metastatic squamous NSCLC.
Source:https://pubmed.ncbi.nlm.nih.gov/34661177/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02775435
Cheng Y, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Sun Y, Li B, Hu X, Schwarzenberger P, Paz-Ares L. Pembrolizumab Plus Chemotherapy for Chinese Patients With Metastatic Squamous NSCLC in KEYNOTE-407. JTO Clin Res Rep. 2021 Sep 25;2(10):100225. doi 10.1016/j.jtocrr.2021.100225. PMID: 34661177; PMCID: PMC8503629.
