Adding sintilimab to pemetrexed and platinum chemotherapy improves overall survival (OS) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC), according to final results from the ORIENT-11 trial. 

Researchers observed an OS benefit with sintilimab across all prespecified subgroups. These results were published in the journal Lung Cancer.

The phase 3 ORIENT-11 trial (ClinicalTrials.gov Identifier: NCT03607539) enrolled patients in China with treatment-naïve locally advanced or metastatic nonsquamous NSCLC without EGFR or ALK sensitizing alterations. 


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The patients were randomly assigned 2:1 to receive sintilimab plus pemetrexed and platinum chemotherapy (n=266) or placebo plus pemetrexed and platinum chemotherapy (n=131). 

After disease progression, patients in the placebo arm could cross over to the sintilimab arm. Ultimately, 47% of the placebo arm crossed over to receive sintilimab.

The median follow-up was 30.8 months. The median OS was 24.2 months in the sintilimab arm and 16.8 months in the placebo arm (hazard ratio [HR], 0.65; 95% CI, 0.50-0.85). The estimated 2-year OS rates were 50% and 32%, respectively. 

The researchers observed an OS benefit with sintilimab regardless of PD-L1 expression, smoking status, age, performance status, and the platinum agent used. 

When the researchers adjusted for crossover from the placebo arm to the sintilimab arm, they found a greater OS benefit with sintilimab (HR, 0.52; 95% CI, 0.38-0.69). 

About half (50.8%) of patients in the sintilimab arm and 67.9% of those in the placebo arm received 1 or more therapies after study treatment (including crossover). Immunotherapy was given to 14.7% of patients in the sintilimab arm and 55.0% of patients in the placebo arm.

“This analysis further confirms the sintilimab combination as a viable treatment option for first-line therapy in metastatic nonsquamous NSCLC without sensitizing EGFR or ALK alterations, regardless of PD-L1 expression status,” the researchers concluded.

Disclosures: This research was supported by Eli Lilly and Company and Innovent Biologics, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Zhang L, Wang Z, Fang J, et al. Final overall survival data of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous NSCLC in the phase 3 ORIENT-11 study. Lung Cancer. Published online July 19, 2022. doi:10.1016/j.lungcan.2022.07.013