CheckMate 227: 3-year follow-up data show durable, long-term OS
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Patients with advanced non-small cell lung cancer who received nivolumab and ipilimumab demonstrated continued durable and long-term overall survival benefits compared with chemotherapy, according to data with 3-year minimum follow-up from the CheckMate 227 part 1 trial presented at the virtual ASCO Annual Meeting.
“We earlier reported that the survival results of the trial were favorable with nivolumab and ipilimumab, and indeed this has been published in The New England Journal of Medicine,” Suresh S. Ramalingam, MD, FASCO, professor and assistant dean and Roberto C. Goizueta distinguished chair for cancer research at Emory University School of Medicine and deputy director of the Winship Cancer Institute of Emory, said in a press conference. “What we are reporting at this meeting is data that have emerged from long-term follow-up of these patients that continue to confirm that the benefits are durable with the combination of nivolumab and ipilimumab.”
Researchers randomly assigned 1,189 patients with stage 4/recurrent non-small cell lung cancer (NSCLC) and a PD-L1 expression of 1% or less in a 1:1:1 ratio to receive 3 mg/kg of nivolumab every 2 weeks in combination with 1 mg/kg ipilimumab every 6 weeks (NIVO-IPI), 240 mg of nivolumab alone every 2 weeks, or chemotherapy. They also randomly assigned 550 patients with a PD-L1 expression of more than 1% to receive either NIVO-IPI, 360 mg of nivolumab every 3 weeks plus chemotherapy, or chemotherapy alone.
Patients with a PD-L1 expression of 1% or less continued to derive overall survival (OS) benefit from NIVO-IPI after a median follow-up of 43.1 months compared with chemotherapy (HR = 0.79; 95% CI, 0.67-0.93). Specifically, the 3-year OS rate was 33% for NIVO-IPI, 29% for nivolumab alone and 22% for chemotherapy, according to the abstract. Moreover, 18% treated with NIVO-IPI remained progression-free at year 3 compared with 12% of patients treated with nivolumab alone and 4% treated with chemotherapy. Of the confirmed responders in the NIVO-IPI arm, 38% remained in response at year 3 compared with 32% for nivolumab and 4% for chemotherapy.
Among patients with a PD-L1 expression of more than 1%, OS benefit was also gained with NIVO-IPI compared chemotherapy (HR = 0.64; 95% CI, 0.51-0.81). The 3-year OS rate was 34% for NIVO-IPI, 20% for nivolumab plus chemotherapy and 15% for chemotherapy alone, the researchers reported. Further, 13% treated with NIVO-IPI remained progression-free at year 3 compared with 8% of patients treated with nivolumab plus chemotherapy, and 2% treated with chemotherapy alone. Of the confirmed responders in the NIVO-IPI arm, 34% remained in response at year 3 compared with 15% for nivolumab plus chemotherapy, and 0% for chemotherapy alone.
“It's clear that the NIVO-IPI regimen is effective in the front-line setting of lung cancer,” Ramalingam said. “Just about a week and a half ago, the U.S. FDA approved the combination of nivolumab and ipilimumab for patients with PD-L1 greater than 1% in the first-line setting.”
The researchers also conducted an exploratory analysis of OS by response status, which included complete response/partial response, stable disease, and progressive disease at 6 months. For patients a PD-L1 expression of 1% or less with either CR/PR, NIVO-IPI conferred a longer subsequent OS compared with chemotherapy, while patients with SD or PD demonstrated similar subsequent OS between treatments, according to the abstract.
“For patients who achieved a complete response or a partial response at the 6 month time point from the time of starting treatment, their 3 year survival rate is 70% for the PD-L1 high group and 82% for the PD-L1 low group,” Ramalingam said.
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Ramalingam SS, et al. Abstract 9500. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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