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Pembrolizumab Still Effective After Five Years for Advanced Non-Small Cell Lung Cancer

Non-small cell lung cancer.

Results of the KEYNOTE-010 study (NCT01905657) have shown that pembrolizumab is more effective than docetaxel for patients with previously treated, advanced non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% and ≥1%. However, what do the results look like after long-term follow-up? According to a study presented this past weekend at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, pembrolizumab continually provides significant survival benefits compared with docetaxel for this patient population five years after initial treatment.

For this study, 1,033 patients with advanced, previously treated NSCLC with PD-L1 TPS ≥1% were enrolled and were randomized in a 1:1:1 ratio to receive either pembrolizumab 2 mg/kg or 10 mg/kg every three weeks or docetaxel 75 mg/m2 every three weeks. Pembrolizumab treatment was administered for 35 cycles (about two years) or until disease progression or unacceptable toxicity. Following disease progression after pembrolizumab discontinuation, those patients who had experienced a complete response and stopped pembrolizumab after at least six months of treatment or who had finished the pembrolizumab treatment were permitted to receive a second course of pembrolizumab for up to 17 cycles, or one year. Every nine weeks, responses were evaluated, and once treatment concluded, survival was assessed every two months.

Median time from randomization to data cutoff was 67.4 months. Median overall survival was found to be higher in the pembrolizumab group than the docetaxel group for both patients with PD-L1 TPS ≥50% (16.9 vs 8.2 months) and PD-L1 TPS ≥1% (11.8 vs 8.4 months). The five-year overall survival rate for patients with PD-L1 TPS ≥50% was 25% in the pembrolizumab group, compared with 8.2% in the docetaxel group. For patients with PD-L1 TPS ≥1%, the five-year overall survival rate was 15.6% in the pembrolizumab group, compared with 6.5% in the docetaxel group.

Median progression-free survival was higher for patients with PD-L1 ≥50% who took pembrolizumab (5.3 vs 4.2 months), while the five-year progression-free survival rate was 18.2% for pembrolizumab versus not reached with docetaxel. In the PD-L1 TPS ≥1% group, median progression-free survival was not improved by pembrolizumab (4.0 months vs 4.1 months for docetaxel), but the five-year progression-free survival rate was substantially higher with pembrolizumab (9.4% vs 0.7%).

"With more than five years of follow-up, pembrolizumab continued to provide clinically meaningful improvement in overall survival and progression-free survival versus docetaxel in patients with previously treated, PD-L1–positive advanced NSCLC; five-year overall survival rates were more than doubled in pembrolizumab-treated patients," conclude the study authors, led by Roy S. Herbst, MD, PhD, Ensign Professor of Medicine at Yale Cancer Center. "Patients who completed 35 cycles or two years of pembrolizumab had durable clinical benefit. Second-course pembrolizumab provided meaningful disease control in the majority of patients who had disease progression after two years of pembrolizumab treatment."

For More Information

Herbst RS et al (2021). 5-Year survival update from KEYNOTE-010: pembrolizumab versus docetaxel in previously treated, PD-L1-positive advanced NSCLC. IASLC World Conference on Lung Cancer. Abstract FP13.01.

Image Credit: Yale Rosen. Licensed under CC BY-SA 2.0

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