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ORIENT-12 Trial: Sintilimab Plus Standard Chemotherapy for Metastatic Lung Cancer

By: Justine Landin, PhD
Posted: Wednesday, June 23, 2021

Addition of the anti–PD-1 antibody sintilimab to standard platinum and gemcitabine chemotherapy may improve clinical outcomes for patients with squamous non–small cell lung cancer (NSCLC), according to results from the ORIENT-12 phase III trial. In particular, patients given sintilimab plus platinum/gemcitabine had increased progression-free survival compared with those given placebo plus platinum/gemcitabine. The results of this multicenter, randomized, double-blind study were published in the Journal of Thoracic Oncology.

“The risk of disease progression or death was reduced by 37.9% at interim analysis and by 46.4% at updated analysis,” stated study author Caicun Zhou, MD, PhD, of Shanghai Pulmonary Hospital, in an International Association for the Study of Lung Cancer press release. “The results from ORIENT-12 could provide a new option for combination therapy in this patient population.”

Patients with squamous NSCLC (stage 3 or 4) and at least one measurable lesion with no previous treatment for advanced or metastatic disease were enrolled (n = 543). Patients with EGFR-sensitive mutations or ALK rearrangements were excluded. Patients were randomly assigned to receive sintilimab (200 mg) or placebo, in addition to platinum and gemcitabine. Treatment was administered every 3 weeks for four to six cycles, and maintenance therapy was conducted for 2 years, or until disease progression. An independent radiographic review committee assessed the primary endpoints.

At the median follow-up of 12.9 months, those who received sintilimab exhibited higher rates of progression-free survival (22.3%) compared with those given placebo (3.1%; hazard ratio = 0.536; 95% confidence interval = 0.422–0.681; P < .00001). Although the median overall survival was not reached, the sintilimab-treated group appeared to exhibit a benefit trend compared with the placebo-treated group (P = .017).

Treatment-related adverse events of grade 3 or higher did not significantly differ between groups (87% with sintilimab, 83% with placebo). Regarding treatment-related deaths, 4.5% and 6.7% of deaths were attributed to the sintilimab and placebo treatments, respectively.  

Disclosure: For full disclosures of the study authors, visit jto.org.



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