Nivolumab prolongs OS in patients with nonsquamous NSCLC
Patients with advanced nonsquamous non–small cell lung cancer achieved longer OS with nivolumab than docetaxel, according to phase 3 study results presented at European Society for Medical Oncology’s European Cancer Congress and simultaneously published in The New England Journal of Medicine.
“Immunotherapy with nivolumab is a new standard of care for treatment of patients with recurrent lung cancer,” study researcher Hossein Borghaei, DO, chief of thoracic oncology at Fox Chase Cancer Center–Temple Health, told HemOnc Today. “Toxicities of this treatment are manageable, but require close follow-up of patients.”
Borghaei and colleagues conducted a phase 3, open-label international, randomized clinical trial to assess the safety and efficacy of nivolumab (Opdivo, Bristol-Myers Squibb) compared with docetaxel in patients with nonsquamous NSCLC after failure of platinum-based doublet chemotherapy.
The analysis included 528 adults (median age, 62 years). Researchers randomly assigned patients (n = 292) to 3 mg/kg of nivolumab every 2 weeks, or 75 mg/m2 of docetaxel every 3 weeks (n = 290).
The researchers assessed survival during treatment as well as every 3 months after treatment ended — with a minimum follow-up for survival of 13.2 months.
At the time of minimum follow-up, patients treated with nivolumab achieved a longer median OS compared with patients treated with docetaxel (12.2 months vs. 9.4 months; HR = 0.73; 95% CI, 0.59-0.89).
More patients assigned nivolumab achieved 18-month OS than patients assigned docetaxel (39% vs. 23%).
In analyses based on PD-L1 expression, researchers found the objective response rate with nivolumab appeared greater among patients with PD-L1 expression in at least 1% of their cells (31% vs. 9%). However, the median duration of response to nivolumab did not differ based on PD-L1 expression (16 months vs. 18.3 months).
The response rate to nivolumab also appeared greater among patients who were current and former smokers vs. never smokers (22% vs. 9%). This association did not persist among patients assigned docetaxel (11% vs. 15%).
Frequencies of any adverse events appeared similar in both cohorts; however, patients assigned nivolumab reported fewer serious adverse events (10%) than patients assigned docetaxel (54%).
The most common treatment-related adverse events in the nivolumab group included fatigue (16%) and nausea (12%).
The most common treatment-related adverse events in the docetaxel group included neutropenia (31%), fatigue (29%) and nausea (26%).
However more research is needed, Borghaei told HemOnc Today.
“It gives us another option for treatment of our patients that is effective,” Borghaei said. “We need to continue our research in defining the patient population that benefits the most from this drug.” – by Ryan McDonald
For more information:
Hossein Borghaei, DO, can be reached at firstname.lastname@example.org.
Horn L, et al. Abstract 3010. Presented at: European Cancer Congress; September 25-29, 2015; Vienna, Austria.
Disclosure: Borghaei reports a consultant/advisory role with Bristol-Myers Squibb, including serving as author, co-author and investigator for several research studies. Please see the study for a full list of all other researchers’ relevant financial disclosures.