WCLC 2020: Adding Sintilimab to Chemotherapy for Nonsquamous NSCLC
Posted: Tuesday, August 11, 2020
According to Li Zhang, MD, of the Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues, the addition of the monoclonal antibody sintilimab to chemotherapy appears to significantly improve progression-free survival in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). The results of the phase III ORIENT-11 trial, which were presented during the virtual 2020 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) Singapore (Abstract 1), suggested this regimen was also fairly well tolerated. Sintilimab has been approved in China in the treatment of resistant Hodgkin lymphoma.
In a 2:1 ratio, a total of 397 patients with untreated locally advanced or metastatic nonsquamous NSCLC were randomly assigned to receive sintilimab (n = 266) or a placebo (n = 131) intravenously with pemetrexed and platinum for four cycles. Subsequently, the patients received either sintilimab or a placebo with pemetrexed as maintenance therapy. To be enrolled, patients must have lacked sensitive EGFR mutations or ALK rearrangements. Follow-up data were provided for a median of 8.9 months.
The majority (75.3%) of planned progression-free survival events were achieved. The investigators reported a significantly longer median progression-free survival in the experimental group, compared with the placebo group (8.9 months vs. 5.0 months; P < .00001). Although the median overall survival was not reached, there appeared to be a nominally significant improvement in the experimental group (P = .01921). The confirmed objective response rates in the experimental and placebo groups were 51.9% versus 29.8%, respectively.
Adverse events of at least grade 3 were reported in 61.7% of the experimental group and in 58.8% of the placebo group. Prior to unblinding, immune-related adverse events were reported in 43.2% of the experimental group and in 36.6% of the placebo group. The safety profile appeared to be congruent with previous reports.
Disclosure: The study authors reported no conflicts of interest.