Issue: July 10, 2015
Perspective from Marina Chiara Garassino, MD
Perspective from Wallace Akerley, MD
June 04, 2015
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CheckMate 017: Nivolumab bests docetaxel in squamous NSCLC

Issue: July 10, 2015
Perspective from Marina Chiara Garassino, MD
Perspective from Wallace Akerley, MD
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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.