Pembrolizumab Significantly Improves 5-Year Survival for Advanced NSCLC Patients Compared With Chemotherapy

By Jeff Craven, /alert Contributor
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Patients with locally advanced or metastatic non-small cell lung cancer (aNSCLC) who received first-line therapy with pembrolizumab had a 5-year survival rate of 23.2%, according to recent research from the KEYNOTE-001 clinical trial.

The results, which were presented at the ASCO 2019 Annual  Meeting in Chicago and will be published in the Journal of Clinical Oncology, suggest a substantial improvement in life expectancy for patients with aNSCLC receiving pembrolizumab as opposed to 5-year survival after chemotherapy, which has traditionally been about 5%.


​Photo by © ASCO

“The uniformly negative outlook that has been associated with a diagnosis of advanced non-small cell lung cancer is certainly no longer appropriate,” Edward B. Garon, MD, MS, associate professor of medicine at UCLA in Los Angeles, Calif., stated in a press release. “The fact that we have patients on this trial that are still alive after 7 years is quite remarkable. We also have evidence that most patients who are doing well after 2 years on pembrolizumab live for 5 years or more.”

The researchers noted KEYNOTE-001 is the longest follow-up of aNSCLC patients receiving pembrolizumab. They evaluated 550 patients who were treatment-naïve (101 patients) or had been previously undergone treatment (449 patients) for locally advanced or metastatic NSCLC and received either pembrolizumab at 2 mg/kg every 3 weeks, 10 mg/kg every 2 weeks or 10 mg/kg every 3 weeks. At median follow-up of 60.6 months, 450 patients had died (82%). Dr. Garon and colleagues also evaluated PD-L1 expression with contemporaneous tumor samples using immunohistochemistry.

Overall, 5-year survival rates for patients receiving first-line therapy was 23.2%, while 5-year survival for patients who had previously received treatment was 15.5%. The overall response rate was 42% (95% confidence interval, 32%-52%) for treatment-naïve patients with a median duration of response of 16.8 months, while previously treated patients had an overall response rate of 23% (95% CI, 19%-27%) and a median duration of response of 38.9 months.

Patients with a PD-L1 tumor proportion score (TPS) ≥ 50% in the treatment-naïve group (35.4 months; 95% CI, 20.3 months‒63.5 months) and the previously treated group (15.4 months; 95% CI, 10.6 months‒18.8 months) had higher median overall survival compared with patients with a PD-L1 TPS between 1% and 49% in the treatment-naïve group (19.5 months; 95% CI, 10.7 months‒26.3 months) and the previously treated group (8.5 months; 95% CI, 6.0 months-12.6 months).

The most common immune-related adverse events (irAEs) seen in the study was hypothyroidism, and the 5-year rate of irAEs was 17%, which researchers noted was similar to the irAE rate at 3 years.

Garon EB, et al. Abstract LBA9015. ASCO 2019 Annual Meeting, May 31-Jun 5; Chicago, IL.