The data, according to the study authors, confirm a recent Food and Drug Administration approval of the regimen and support its use in the front-line treatment of patients with advanced non-small cell lung cancer.
Treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) and two cycles of platinum doublet chemotherapy in the front-line setting was associated with a significant improvement in overall survival in patients with advanced non-small cell lung cancer, compared to treatment with chemotherapy alone.
Moreover, the data demonstrated that treatment with the combination resulted in significant improvements in progression-free survival (the time from treatment to disease progression or worsening) and objective responses to therapy.
“Efficacy and safety data support a favorable risk–benefit profile for (Opdivo) plus (Yervoy) combined with chemotherapy as first-line treatment for patients with advanced (non-small cell lung cancer),” the authors wrote in the study published in Lancet Oncology.
Previously, first-line treatment with Opdivo plus Yervoy has demonstrated improvement in overall survival in this patient population. However, the study authors aimed to assess if the addition of chemotherapy to this regimen would further improve overall survival.
The authors enrolled 1,150 patients with treatment-naive, histologically confirmed stage 4 or recurrent non-small-cell lung cancer from 103 hospitals in 19 different countries. Of those enrolled onto the phase 3 CheckMate 9LA study, 719 were eligible to receive treatment.
Patients were then randomized to receive 360 milligrams of Opdivo every three weeks plus 1 milligram of Yervoy every six weeks in combination with platinum chemotherapy every three weeks for two cycles (361 patients) or chemotherapy alone every three weeks for four cycles (358 patients).
At a median follow-up of 9.7 months (a pre-specified analysis of the data), overall survival was significantly improved in those who received the combination (14.1 months) compared to those who received chemotherapy alone (10.7 months).
Based on findings from that pre-specified analysis, the Food and Drug Administration approved this regimen as a first-line treatment option for this patient population in May 2020.
Here, the study authors published updated data with an additional 4.6 months of minimum follow-up. The updated data demonstrated that at a median follow up of 13.2 months, treatment with Opdivo plus Yervoy and two cycles of chemotherapy was still superior than chemotherapy alone at improving overall survival(15.6 months versus 10.9 months).
Moreover, median progression-free survival was 6.8 months in those who received the combination regimen and 5 months in those who received chemotherapy alone.Patients who received the combination regimen achieved a 37.7% objective response rate (the proportion of patients who had a complete or partial response to treatment) compared to 25.1% in those who received chemotherapy alone.
Side effects occurred in 168 patients in the combination regiment group and 132 patients in the chemotherapy alone group. The most common side effects included low white blood cell count, anemia, diarrhea, increased lipase and lack of energy. There were 58 patients in the combination regimen group and 16 patients in the chemotherapy alone group who discontinued treatment due to treatment-related side effects. There were 106 serious or severe treatment-related side effects in the combination regimen group and 62 in the chemotherapy alone group.
The authors did note, however, that there were some limitations with the study, including the short follow-up and that single agent chemotherapy is no longer a standard of care.
“As the study is still maturing, longer follow-up will provide further characterization of the risk–benefit profile of (Opdivo) plus (Yervoy) combined with chemotherapy in this setting.”
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