Combination Immunochemotherapy in Locally Advanced or Metastatic NSCLC
Posted: Monday, October 26, 2020
According to the phase III ORIENT-11 study findings, Chinese patients experienced significantly longer progression-free survival when treated with the anti–PD-1 antibody sintilimab added to standard chemotherapy with pemetrexed and platinum, compared with chemotherapy alone. Li Zhang, MD, of Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues reported these results in the Journal of Thoracic Oncology.
In this double-blind study, patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) were randomly given treatment with 200 mg of sintilimab or placebo combined with pemetrexed and platinum once every 3 weeks for four cycles. Afterward, they received sintilimab or placebo plus pemetrexed. The primary endpoint of the study was progression-free survival.
A total of 397 eligible patients were enrolled and randomly assigned to the treatment arm (n = 266) or placebo arm (n = 131); the median duration of treatment was 7.1 months and 5.5 months, respectively. The median progression-free survival was 8.9 months with the sintilimab combination and 5.0 months with the placebo combination. Progression-free survival at 6 months was 68.3% in the sintilimab-combination group and 42.0% in the placebo-combination group. Adverse events of grade 3 or higher were observed in 61.7% of patients (n = 164) given the sintilimab combination and in 58.8% of patients (n = 77) given the placebo combination.
The addition of sintilimab to pemetrexed and platinum compared with standard chemotherapy alone prolonged median progression-free survival by 3.9 months (8.9 vs. 5.0 months) and reduced the risk of death by 39.1%. According to the study authors, their study results demonstrated that the combination regimen might offer a new treatment option for patients with NSCLC.
Disclosure: The study authors reported no conflicts of interest.