CheckMate 9LA: First-Line Immunotherapy Plus Chemotherapy in NSCLC
Posted: Thursday, March 25, 2021
The addition of two chemotherapy cycles to the standard treatment of nivolumab plus ipilimumab demonstrated a “significant improvement” in overall survival compared with chemotherapy alone for patients with non–small cell lung cancer (NSCLC), according to the findings of the phase III CheckMate 9LA trial published in The Lancet Oncology. This regimen was associated with a favorable risk-benefit profile, as compared with chemotherapy alone, and should be considered a new first-line treatment for this patient population, according to Martin Reck, MD, of the Lung Clinic Grosshansdorf, Germany, and colleagues.
“Benefit improved with longer follow-up and was observed in most subgroups, except for patients who had never smoked…and older patients (> 75),” the authors commented.
From 2017 to 2019, a total of 719 patients with stage IV or recurrent NSCLC were enrolled in the study. Patients were randomly assigned to receive intravenous nivolumab (360 mg every 3 weeks), intravenous ipilimumab (1 mg/kg every 6 weeks), and two doses of intravenous platinum doublet chemotherapy every 3 weeks (n = 361) or four doses of intravenous platinum doublet chemotherapy every 3 weeks (n = 358).
The authors reported an overall increased survival with the addition of the immunotherapies (14.1 months) as compared with chemotherapy alone (10.7 months) at the interim analysis (hazard ratio = 0.69). The trend remained consistent after 3 to 5 months of follow-up, 13.2 months versus 10.9 months, respectively.
Furthermore, the authors identified differences in grade 3 or 4 adverse events between the treatment groups. They included neutropenia (7% with immunotherapies vs. 9% with chemotherapy alone), anemia (6% vs. 14%), increased lipase levels (6% vs. 1%), diarrhea (4% vs. 1%), and asthenia (1% vs. 2%). Moreover, both groups experienced a similar number of treatment-related deaths (seven with immunotherapies and six with chemotherapy alone).
Disclosure: For full disclosures of the study authors, visit thelancet.com.
