KEY TAKEAWAYS
- KEYNOTE-407 is a phase III clinical trial evaluating the efficacy and safety of pembrolizumab plus chemotherapy in the first-line treatment of metastatic squamous NSCLC.
- The trial’s primary endpoints were overall survival (OS) and progression-free survival (PFS) as measured by BICR.
- The results showed a significant improvement in OS and PFS. The 5-year OS rate was 18.4% for pembrolizumab plus chemotherapy and 9.7% for placebo plus chemotherapy.
T he phase III KEYNOTE-407 study looked at how well it worked and how safe it was for 5 years. Patients with metastatic squamous non-small-cell lung cancer (NSCLC) who had never been treated were given either pembrolizumab 200 mg or a placebo plus carboplatin and paclitaxel/nab-paclitaxel once every 3 weeks for 4 cycles. Afterward, they got pembrolizumab or a placebo for up to 35 cycles.
Overall survival (OS) and progression-free survival (PFS) according to RECIST version 1.1 by blinded independent central review (BICR) were the main goals. In the “intention-to-treat” population, 559 patients were randomly given either pembrolizumab plus chemotherapy or placebo plus chemotherapy. The median time from random assignment to the end of the data collection period was 56.9 months (range: 49.9–66.2). OS and PFS were better with pembrolizumab plus chemotherapy than with placebo plus chemotherapy (hazard ratio [95% CI], 0.71 [0.59 to 0.85] and 0.62 [0.52 to 0.74]), with 5-year OS rates of 18.4% versus 9.7%, respectively. The toxicity wasn’t too bad.
The objective response rate was 90.9% among the 55 patients who finished 35 cycles of pembrolizumab, and the 3-year OS rate after finishing 35 cycles (about 5 years after random assignment) was 69.5%. Pembrolizumab plus chemotherapy was better than placebo plus chemotherapy for OS and PFS patients with metastatic squamous NSCLC who had not been treated before. Pembrolizumab is a standard first-line treatment for metastatic squamous NSCLC, regardless of how much-programmed death ligand 1 is expressed.
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02775435
Novello S, Kowalski DM, Luft A, Gümüş M, Vicente D, Mazières J, Rodríguez-Cid J, Tafreshi A, Cheng Y, Lee KH, Golf A, Sugawara S, Robinson AG, Halmos B, Jensen E, Schwarzenberger P, Pietanza MC, Paz-Ares L. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol. 2023 Feb 3:JCO2201990. doi: 10.1200/JCO.22.01990. Epub ahead of print. PMID: 36735893.
