Issue: July 10, 2015
Perspective from Marina Chiara Garassino, MD
Perspective from Wallace Akerley, MD
June 04, 2015
3 min read

CheckMate 017: Nivolumab bests docetaxel in squamous NSCLC

Issue: July 10, 2015
Perspective from Marina Chiara Garassino, MD
Perspective from Wallace Akerley, MD
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

CHICAGO — Nivolumab improved survival outcomes compared with docetaxel in a cohort of patients with squamous non–small cell lung cancer, according to findings presented at the ASCO Annual Meeting.

David R. Spigel, MD, an oncologist at the Sarah Cannon Research Institute/Tennessee Oncology in Nashville, and colleagues compared nivolumab (Opdivo, Bristol-Myers Squibb) and docetaxel in a cohort of 272 patients with squamous NSCLC who had failed one previous platinum-based doublet chemotherapy regimen.

Researchers randomly assigned 135 patients 3 mg/kg nivolumab arm every 2 weeks and 137 patients 75 mg/m2 docetaxel every 3 weeks until disease progression, discontinuation due to toxicity or other factors.

OS served as the primary endpoint. Investigator-assessed objective response rate (ORR), PFS, efficacy by PD-L1 expression, quality of life and safety served as the secondary outcome measures.

Patients in the nivolumab arm achieved a median OS of 9.2 months (95% CI, 7.3-13.3), whereas the median OS in the docetaxel arm was 6 months (95% CI, 5.1-7.3; HR = 0.59; 95% CI, 0.44-0.79).

Forty-two percent (95% CI, 34-50) of patients in the nivolumab arm achieved 1-year OS compared with 24% (95% CI, 17-31) of patients in the docetaxel arm.

PFS was 3.5 months (95% CI, 2.1-4.9) in the nivolumab arm and 2.8 months (95% CI, 2.1-3.5) in the docetaxel arm (HR = 0.62; 95% CI, 0.47-0.81). More patients assigned nivolumab also achieved 1-year PFS (21% vs. 6%).

Spigel reported an ORR of 20% for nivolumab and 9% for docetaxel (P = .0083).  The median duration of response was not reached in patients treated with nivolumab, but was 8.4 months (1.4+ to 15.2+) among those treated with docetaxel.

“The median time to response for both drugs is essentially equivalent,” Spigel said.

Nivolumab demonstrated a survival benefit in patients with 1% or greater PD-L1 expression HR = 0.69; 95% CI, 0.45, 1.05), 5% or greater PD-L1 expression (HR = 0.53; 95% CI, 0.31, 0.89) and 10% or greater PD-L1 expression (HR = 0.5; 95% CI, 0.28, 0.89).

 “The survival benefit of nivolumab was independent of PD-L1 expression levels,” Spigel said. “A benefit was seen among patients with 1%, 5% or 10% PD-L1 expression, and the benefit was consistently higher for nivolumab.”

A 7% rate of grade 3 to grade 4 drug-related events occurred among patients treated with nivolumab, whereas 57% of patients receiving docetaxel experienced grade 3 to grade 4 events.

No deaths were related to nivolumab; however, three deaths occurred in the docetaxel arm.

“Nivolumab is the first PD-1 inhibitor to demonstrate a survival benefit vs. standard-of-care docetaxel in previously treated patients with advanced squamous NSCLC,” Spigel said. “Nivolumab demonstrates superiority across all secondary efficacy endpoints.”

Spigel added that safety outcomes were consistent with previous studies. – by Rob Volansky

For more information:

Spigel DL, et al. Abstract 8009. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.

Disclosure: Spigel reports no relevant financial disclosures. Please see the abstract for a full list of the other researchers’ relevant financial disclosures.