Adding sintilimab to chemotherapy improves overall survival (OS) in patients with advanced, nonsquamous non-small cell lung cancer (NSCLC), according to final results from the phase 3 ORIENT-11 trial.

Patients who received sintilimab plus chemotherapy had significantly longer OS at a median follow-up of 2.6 years, when compared with patients who received placebo plus chemotherapy.

These results were presented at the 2022 European Lung Cancer Congress (ELCC) by Yunpeng Yang, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China.

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The ORIENT-11 trial ( Identifier: NCT03607539) enrolled 397 patients with locally advanced or metastatic nonsquamous NSCLC without sensitizing EGFR or ALK aberrations. The patients were randomly assigned 2:1 to receive first-line sintilimab plus chemotherapy (n=266) or placebo plus chemotherapy (n=131). Baseline characteristics were generally balanced between the treatment arms.

Initial treatment consisted of pemetrexed plus cisplatin or carboplatin, with sintilimab or placebo, for up to 4 cycles. This was followed by maintenance with pemetrexed plus sintilimab or placebo until disease progression.

At the data cutoff (September 15, 2021), the median follow-up was 30.8 months. Nearly half (47%) of patients in the placebo arm had crossed over to receive sintilimab monotherapy after disease progression.

Without accounting for crossover, patients in the sintilimab arm had significantly longer OS. The median OS was 24.2 months with sintilimab and 16.8 months with placebo (hazard ratio [HR], 0.65; 95% CI, 0.50-0.85). The estimated 2-year OS rate was 50% and 32%, respectively.

When the data were adjusted for the crossover effect, the OS benefit derived from sintilimab was more pronounced, with an HR of 0.52 (95% CI, 0.38-0.69).

The OS benefit with sintilimab was largely consistent across prespecified subgroups, including by age, performance status, platinum agent, and PD-L1 expression.

When patients were analyzed by disease stage, the OS trend was similar between patients with stage IIIB or IIIC disease (n=36; HR, 0.30; 95% CI, 0.10-0.89) and those with stage IV disease (n=361; HR, 0.67; 95% CI, 0.51-0.88).

Based on these results, Dr Yang concluded that the “treatment effect of sintilimab plus chemotherapy on OS was robust and consistent with other PD-L1 inhibitors in this indication.”

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


Yang Y, Wang Z, Fang J, et al. Final overall survival (OS) data of sintilimab plus pemetrexed (SPP) and platinum as first-line (1L) treatment for locally advanced or metastatic nonsquamous NSCLC (AMnsqNSCLC) in the phase 3 ORIENT-11 study. Presented at ELCC 2022; March 30 – April 2, 2022. Abstract 4MO.